Avandamet

Generic Name: rosiglitazone and metformin (Oral route)

met-FOR-min hye-droe-KLOR-ide, roe-zi-GLI-ta-zone MAL-ee-ate

Oral route(Tablet)

May cause or worsen congestive heart failure, is not recommended in patients with symptomatic heart failure, and is contraindicated in patients with established NYHA Class III or IV heart failure. Monitor patients for signs and symptoms of heart failure after initiation or dose increases and if heart failure occurs, consider dose reducing or discontinuing rosiglitazone maleate and manage according to current standards of care. A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared rosiglitazone to placebo, showed rosiglitazone to be associated with a statistically significant increased risk of myocardial infarction. Because of the potential increased risk of myocardial infarction, rosiglitazone maleate/metformin hydrochloride is available only through a restricted distribution program called the AVANDIA-Rosiglitazone Medicines Access Program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-AVANDIA or visit www.AVANDIA.com .Lactic acidosis can occur due to metformin accumulation during treatment with rosiglitazone maleate/metformin hydrochloride. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Commonly used brand name(s)

In the U.S.

• Avandamet

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

Uses For Avandamet

Rosiglitazone and metformin combination is used to treat a type of diabetes mellitus called type 2 diabetes. It is used together with a proper diet and exercise to help control blood sugar levels.

Rosiglitazone helps your body use insulin better. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better.

This medicine is only available through a restricted access program. Doctors who are enrolled in the program can write a prescription for this medicine.

Before Using Avandamet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rosiglitazone and metformin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rosiglitazone and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving rosiglitazone and metformin combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid


• Diatrizoate


• Ethiodized Oil


• Iobenzamic Acid


• Iobitridol


• Iocarmic Acid


• Iocetamic Acid


• Iodamide


• Iodipamide


• Iodixanol


• Iodohippuric Acid


• Iodopyracet


• Iodoxamic Acid


• Ioglicic Acid


• Ioglycamic Acid


• Iohexol


• Iomeprol


• Iopamidol


• Iopanoic Acid


• Iopentol


• Iophendylate


• Iopromide


• Iopronic Acid


• Ioseric Acid


• Iosimide


• Iotasul


• Iothalamate


• Iotrolan


• Iotroxic Acid


• Ioversol


• Ioxaglate


• Ioxitalamic Acid


• Ipodate


• Metrizamide


• Metrizoic Acid


• Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetazolamide


• Alatrofloxacin


• Balofloxacin


• Cimetidine


• Ciprofloxacin


• Clinafloxacin


• Dichlorphenamide


• Dofetilide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Topiramate


• Tosufloxacin


• Trovafloxacin Mesylate


• Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Cephalexin


• Clorgyline


• Dilevalol


• Enalaprilat


• Enalapril Maleate


• Esmolol


• Fenofibrate


• Fenugreek


• Gemfibrozil


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Rifampin


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine


• Trimethoprim


• Trospium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem (underactive) or


• Dehydration, severe or


• Kidney problems or


• Liver disease or


• Pituitary gland problem (underactive) or


• Poorly nourished condition or


• Sepsis (severe infection) or


• Weakened physical condition—Use with caution. May cause side effects to become worse.

• Anemia (low red blood cells) or


• Diabetic macular edema (swelling of the back of the eye) or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease, history of or


• Liver disease or


• Vitamin B12 deficiency—Use with caution. May make these conditions worse.

• Angina, severe and acute or


• Diabetic ketoacidosis (high ketones in the blood) or


• Heart attack, acute or


• Heart failure, severe or with symptoms or


• Kidney disease, severe or


• Liver disease, active or


• Metabolic acidosis (acid in the blood) or


• Type 1 diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—Use with caution. These conditions may cause problems with blood sugar control.

• Fragile bones (especially in women)—Use with caution. This medicine may increase the risk for fractures.

Proper Use of Avandamet

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine is only available through a restricted access program. Both you and your doctor must enroll in this program. You might have to sign a consent form in order to receive this medicine and your doctor will closely monitor your progress while you are taking this medicine. Talk to your doctor if you have questions about this.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine should be taken with meals to help reduce the unwanted stomach effects that may occur during the first few weeks.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For type 2 diabetes:
    
    • For patients on metformin therapy:
      
      • Adults—rosiglitazone 4 milligrams (mg) per day plus the dose of metformin already being taken, divided into two doses. Your doctor may adjust your dose as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients on rosiglitazone therapy:
      
      • Adults—metformin 1000 milligrams (mg) per day plus the dose of rosiglitazone already being taken, divided into two doses. Your doctor may adjust your dose as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients not on metformin or rosiglitazone therapy:
      
      • Adults—rosiglitazone 2 milligrams (mg) plus metformin 500 mg once a day or two times a day as directed by your doctor. Your doctor may adjust your dose as needed. However, the maximum dose is rosiglitazone 8 mg plus metformin 2000 mg per day, divided into two doses.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients previously treated with rosiglitazone and metformin:
      
      • Adults—The dose is the same as the dose you are already taking. Your doctor may adjust your dose as needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Avandamet

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor right away if you have chest pain or discomfort; nausea; pain or discomfort in the arms, jaw, back, or neck; shortness of breath; sweating; or vomiting. These may be symptoms of a heart attack.

If you are rapidly gaining weight or having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor right away. These may be symptoms of a heart problem or edema (fluid retention).

Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to stop taking this medicine before you have major surgery or diagnostic tests, especially tests that use a contrast dye.

Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. The symptoms of lactic acidosis include: abdominal or stomach discomfort; decreased appetite; diarrhea; fast or shallow breathing; a general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.

If you have abdominal or stomach pain; dark urine; a loss of appetite; nausea or vomiting; unusual tiredness or weakness; or yellow eyes or skin, check with your doctor right away. These may be symptoms of a serious liver problem.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs while you are taking this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Certain women may be at an increased risk for pregnancy while taking this medicine. If you had problems ovulating and had irregular periods in the past, this medicine may cause you to ovulate. This could increase your chance of becoming pregnant. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

This medicine may increase the risk for bone fractures in women. Ask your doctor about ways to keep your bones strong to help prevent fractures.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

It is very important to follow carefully any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your doctor.


• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.


• Symptoms of fluid retention—Know what to do if you start to retain fluid. Fluid retention may worsen or lead to heart problems.

This medicine can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

• Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.


• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your family also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.


• If the symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

Avandamet Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Pale skin


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Anxiety


• blurred vision


• chest pain or discomfort


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• dilated neck veins


• dizziness


• extreme fatigue


• fast heartbeat


• headache


• increased hunger


• irregular breathing


• irregular heartbeat


• nausea


• nervousness


• nightmares


• seizures


• shakiness


• shortness of breath


• slurred speech


• swelling of the face, fingers, feet, or lower legs


• weight gain


• wheezing

Rare

• Abdominal or stomach discomfort


• decreased appetite


• diarrhea


• fast, shallow breathing


• general feeling of discomfort


• muscle pain or cramping


• sleepiness

Incidence not known

• Change in vision


• dark urine


• decreased urine output


• hives or welts


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• pain or discomfort in the arms, jaw, back, or neck


• redness of the skin


• skin rash


• stomach pain


• sweating


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• cough, fever, sneezing, or sore throat


• difficulty with breathing


• ear congestion


• loss of voice


• pain or tenderness around the eyes and cheekbones


• stuffy or runny nose


• tightness of the chest

Less common

• Back pain


• cold or flu-like symptoms


• difficulty with moving


• pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Avandamet side effects (in more detail)

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More Avandamet resources

• Avandamet Side Effects (in more detail)
• Avandamet Dosage
• Avandamet Use in Pregnancy & Breastfeeding
• Drug Images
• Avandamet Drug Interactions
• Avandamet Support Group
• 3 Reviews for Avandamet - Add your own review/rating

• Avandamet Prescribing Information (FDA)


• Avandamet MedFacts Consumer Leaflet (Wolters Kluwer)


• Avandamet Consumer Overview

Compare Avandamet with other medications

• Diabetes, Type 2

ambenonium

Generic Name: ambenonium (am ben OH nee um)

Brand Names: Mytelase Chloride

What is ambenonium?

Ambenonium affects chemicals in the body that are involved in the communication between nerve impulses and muscle movement.

Ambenonium is used to treat the symptoms of myasthenia gravis.

Ambenonium may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ambenonium?

You should not use this medication if you are allergic to ambenonium, or if you are using certain medications.

Be sure your doctor knows if you use: mecamylamine, (Inversine), atropine (Atreza, Donnatal, Sal-Tropine, Lomotil, Lomocot, and others), blood pressure medications, or a diuretic (water pill).

Before using ambenonium, tell your doctor if you have asthma, Parkinson's disease, or a bladder or bowel obstruction.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

What should I discuss with my health care provider before taking ambenonium?

You should not use this medication if you are allergic to ambenonium, or if you are using certain medications. Be sure your doctor knows if you use:

• 
  

  mecamylamine, (Inversine);

  
  


• 
  

  atropine (Atreza, Donnatal, Sal-Tropine, Lomotil, Lomocot, and others);

  
  


• 
  

  blood pressure medications; or

  
  


• 
  

  a diuretic (water pill).

  
  

To make sure you can safely take ambenonium, tell your doctor if you have any of these other conditions:

• 
  

  asthma;

  
  


• 
  

  Parkinson's disease; or

  
  


• 
  

  a bladder or bowel obstruction.

  
  

It is not known whether ambenonium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ambenonium passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ambenonium.

How should I take ambenonium?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Ambenonium is usually taken every 3 to 4 hours during the day. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe diarrhea, muscle twitching, anxiety, sweating, and cough or breathing problems.

What should I avoid while taking ambenonium?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Ambenonium side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe diarrhea;

  
  


• 
  

  muscle twitching; or

  
  


• 
  

  cough with sputum (mucus).

  
  

Less serious side effects may include:

• 
  

  sweating or urinating more than usual;

  
  


• 
  

  drooling, watery eyes;

  
  


• 
  

  warmth or tingly feeling;

  
  


• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  blurred vision;

  
  


• 
  

  anxiety;

  
  


• 
  

  dizziness, spinning feeling; or

  
  


• 
  

  muscle cramps.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ambenonium?

Tell your doctor about all other medicines you use, especially:

• 
  

  atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  bladder or urinary medicines such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

  
  


• 
  

  ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

  
  

This list is not complete and other drugs may interact with ambenonium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More ambenonium resources

• Ambenonium Side Effects (in more detail)
• Ambenonium Use in Pregnancy & Breastfeeding
• Ambenonium Drug Interactions
• Ambenonium Support Group
• 0 Reviews for Ambenonium - Add your own review/rating

• Ambenonium MedFacts Consumer Leaflet (Wolters Kluwer)

Compare ambenonium with other medications

• Myasthenia Gravis

Where can I get more information?

• Your pharmacist can provide more information about ambenonium.

See also: ambenonium side effects (in more detail)

Ambifed CD

Pronunciation: KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Codeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Ambifed CD and Maxifed-G CDX

Ambifed CD is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambifed CD is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Ambifed CD if:

• you are allergic to any ingredient in Ambifed CD or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are having an asthma attack


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ambifed CD:

Some medical conditions may interact with Ambifed CD. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, dihydrocodeine, hydrocodone, oxycodone)


• if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems


• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus


• if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions


• if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Ambifed CD. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine ), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Ambifed CD's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Ambifed CD's effectiveness


• Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Ambifed CD


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Ambifed CD

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ambifed CD may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ambifed CD:

Use Ambifed CD as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambifed CD by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Drink plenty of water while taking Ambifed CD.


• If you miss a dose of Ambifed CD, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ambifed CD.

Important safety information:

• Ambifed CD may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ambifed CD with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ambifed CD; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Ambifed CD may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not take diet or appetite control medicines while you are taking Ambifed CD without checking with your doctor.


• Ambifed CD has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.


• If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.


• Do not use Ambifed CD for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Ambifed CD may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ambifed CD. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Ambifed CD may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ambifed CD.


• Tell your doctor or dentist that you take Ambifed CD before you receive any medical or dental care, emergency care, or surgery.


• Use Ambifed CD with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Ambifed CD in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Ambifed CD should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ambifed CD while you are pregnant. Ambifed CD is found in breast milk. Do not breast-feed while taking Ambifed CD.

Possible side effects of Ambifed CD:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ambifed CD side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ambifed CD:

Store Ambifed CD at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ambifed CD out of the reach of children and away from pets.

General information:

• If you have any questions about Ambifed CD, please talk with your doctor, pharmacist, or other health care provider.


• Ambifed CD is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ambifed CD. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ambifed CD resources

• Ambifed CD Side Effects (in more detail)
• Ambifed CD Use in Pregnancy & Breastfeeding
• Ambifed CD Drug Interactions
• Ambifed CD Support Group
• 0 Reviews for Ambifed CD - Add your own review/rating

• Ambifed CD Concise Consumer Information (Cerner Multum)


• Novahistine Expectorant Concise Consumer Information (Cerner Multum)

Compare Ambifed CD with other medications

• Cold Symptoms

Altafrin

Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.

• AK-Dilate


• Altafrin


• Eye Cool


• Mydfrin


• Neofrin


• Neo-Synephrine


• Ocu-Phrin


• Prefrin Liquifilm

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Uses For Altafrin

Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.

Before Using Altafrin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.

Geriatric

Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Nialamide


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline


• Amoxapine


• Clomipramine


• Desipramine


• Dothiepin


• Doxepin


• Furazolidone


• Imipramine


• Lofepramine


• Midodrine


• Nortriptyline


• Opipramol


• Pargyline


• Protriptyline


• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Guanethidine


• Propranolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or


• Heart or blood vessel disease or


• High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse

• Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur

Proper Use of phenylephrine

This section provides information on the proper use of a number of products that contain phenylephrine. It may not be specific to Altafrin. Please read with care.

Do not use if the solution turns brown or becomes cloudy.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

• It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  
  • For eye redness:
    
    • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.
    
    
  
  
  • For eye exams:
    
    • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.
    
    
  
  
  • For use before eye surgery:
    
    • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.
    
    
    • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.
    
    
  
  
  • For certain eye conditions:
    
    • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.
    
    
    • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For non-prescription strength eye drops, follow the package directions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Altafrin

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

For patients using the 2.5 or 10% eye drops:

• After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Altafrin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution

• Dizziness


• fast, irregular, or pounding heartbeat


• increased sweating


• increase in blood pressure


• paleness


• trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common with 2.5 or 10% solution

• Burning or stinging of eyes


• headache or browache


• sensitivity of eyes to light


• watering of eyes

Less common

• Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Altafrin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Altafrin resources

• Altafrin Side Effects (in more detail)
• Altafrin Use in Pregnancy & Breastfeeding
• Altafrin Drug Interactions
• Altafrin Support Group
• 0 Reviews for Altafrin - Add your own review/rating

• Altafrin Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• AK-Dilate Concise Consumer Information (Cerner Multum)


• AK-Dilate Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Altafrin with other medications

• Eye Dryness/Redness
• Eye Redness/Itching
• Pupillary Dilation

aminohippurate sodium Intravenous

a-mee-noe-HIP-ue-rate SOE-dee-um

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Kidney Function

Uses For aminohippurate sodium

Aminohippurate sodium is used as a diagnostic agent to measure kidney function.

aminohippurate sodium is to be given only by or under the direct supervision of a doctor.

Before Using aminohippurate sodium

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aminohippurate sodium or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aminohippurate sodium in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aminohippurate sodium in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or


• Heart disease—Use with caution. May make these conditions worse.

Proper Use of aminohippurate sodium

A doctor or other trained health professional will give you aminohippurate sodium in a hospital. aminohippurate sodium is given through a needle placed in one of your veins.

Precautions While Using aminohippurate sodium

Your doctor will check your progress closely while you are receiving aminohippurate sodium. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

The vial stopper of aminohippurate sodium contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you receive aminohippurate sodium.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

aminohippurate sodium Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Cough


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Desire to defecate or urinate during or shortly after infusion


• feeling of warmth


• muscle cramps


• nausea


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• tingling of the skin


• vomiting


• welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More aminohippurate sodium Intravenous resources

• Aminohippurate sodium Intravenous Support Group
• 0 Reviews for Aminohippurate sodium Intravenous - Add your own review/rating

Compare aminohippurate sodium Intravenous with other medications

• Diagnosis and Investigation

Ansaid

Generic Name: flurbiprofen (Oral route)

flur-bi-PROE-fen

Oral route(Tablet)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Flurbiprofen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Ansaid

Available Dosage Forms:

• Tablet


• Capsule, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Ansaid

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Flurbiprofen may also be used for other problems as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Ansaid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of flurbiprofen in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of flurbiprofen in the elderly. However, elderly patients are more likely to have age-related kidney and gastrointestinal problems, which may require caution and an adjustment in the dose for patients receiving flurbiprofen.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acenocoumarol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dicumarol


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


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• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


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• Landiolol


• Levobetaxolol


• Levobunolol


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• Losartan


• Mepindolol


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• Olmesartan Medoxomil


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• Penbutolol


• Pentopril


• Perindopril


• Phenprocoumon


• Pindolol


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• Polythiazide


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• Quinapril


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• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Bleeding problems or


• Congestive heart failure or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Proper Use of Ansaid

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

To lessen stomach upset, you may take this medicine with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—At first, 200 to 300 milligrams (mg) per day, divided into two to four equal doses. Your doctor may adjust your dose as needed. However, each dose usually is not more than 100 mg.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ansaid

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines such as steroids or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs are including black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, and/or lower legs; unusual bleeding or bruising; unusual weight gain; or yellow skin or eyes . Also, signs of serious heart problems could occur such as chest pain, fast or irregular heartbeat, slurring of speech, tightness in the chest, unusual flushing or warmth of the skin, or weakness. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ansaid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Abdominal or stomach pain


• bladder pain


• bloody or black, tarry stools


• bloody or cloudy urine


• constipation


• difficult, burning, or painful urination


• frequent urge to urinate


• lower back or side pain


• rash


• severe stomach pain


• swelling


• vomiting of blood or material that looks like coffee grounds

Rare

• Back or leg pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody diarrhea


• bloody nose


• blurred vision


• burning feeling in the chest or stomach


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• clay-colored stools


• cough


• cracks in the skin


• dark urine


• decreased urine output


• difficulty breathing


• difficulty swallowing


• dilated neck veins


• dizziness


• extreme fatigue


• fast heartbeat


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• fever with or without chills


• flushing or redness of the skin, especially on the face and neck


• general feeling of tiredness or weakness


• greatly decreased frequency of urination


• headache


• high fever


• hives


• hoarseness


• increased blood pressure


• increased sensitivity of the skin to sunlight


• increased thirst


• indigestion


• irregular breathing


• irregular heartbeat


• itching


• joint pain, stiffness, or swelling


• large, flat, blue, or purplish patches in the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of heat from the body


• muscle pain


• nausea


• nervousness


• noisy breathing


• nosebleeds


• pale skin


• pinpoint red or purple spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness or other discoloration of the skin


• redness, swelling, or soreness of the tongue


• scaly skin


• severe or continuing stomach pain


• severe sunburn


• shakiness and unsteady walk


• shortness of breath


• skin rash, encrusted, scaly and oozing


• slow or fast heartbeat


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stomach bloating or cramping


• stomach upset


• sweating


• swelling of the face, fingers, feet, or lower legs


• swelling or inflammation of the mouth


• swollen or painful glands


• tenderness in the stomach area


• tightness in the chest


• troubled breathing


• unpleasant breath odor


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• vomiting


• weight gain


• weight loss


• wheezing


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptom of overdose

• Change in consciousness


• fast or slow, or shallow breathing


• heartburn


• loss of consciousness


• pain or discomfort in the chest, upper stomach, or throat


• pale or blue lips, fingernails, or skin


• unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach


• belching


• changes in vision


• continuing ringing or buzzing or other unexplained noise in the ear


• diarrhea


• discouragement


• excess air or gas in the stomach or intestines


• fear


• feeling of constant movement of self or surroundings


• feeling sad or empty


• full feeling


• general feeling of discomfort or illness


• hearing loss


• irritability


• lack of appetite


• lack or loss of strength


• lightheadedness


• loss of interest or pleasure


• loss of memory


• passing gas


• problems with memory


• runny nose


• sensation of spinning


• sleepiness


• sleeplessness


• sneezing


• stomach discomfort


• stuffy nose


• tremor


• trouble concentrating


• trouble sleeping


• unable to sleep

Rare

• Burning, dry, or itching eyes


• confusion


• discharge or excessive tearing


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• transient, mild, pleasant aromatic odor


• twitching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Ansaid side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Ansaid resources

• Ansaid Side Effects (in more detail)
• Ansaid Use in Pregnancy & Breastfeeding
• Drug Images
• Ansaid Drug Interactions
• Ansaid Support Group
• 2 Reviews for Ansaid - Add your own review/rating

• Ansaid Concise Consumer Information (Cerner Multum)


• Ansaid Prescribing Information (FDA)


• Ansaid MedFacts Consumer Leaflet (Wolters Kluwer)


• Ansaid Monograph (AHFS DI)


• Flurbiprofen Professional Patient Advice (Wolters Kluwer)


• Flurbiprofen Sodium eent Monograph (AHFS DI)

Compare Ansaid with other medications

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Angiomax

Generic Name: Bivalirudin
Class: Direct Thrombin Inhibitors
Chemical Name: d - Phenylalanyl - l - prolyl - l - arginyl - l - prolylglycylglycylglycylglycyl - l - asparaginylglycyl - l - α - aspartyl - l - phenylalanyl - l - α - glutamyl - l - α - glutamyl - l - isoleucyl - l - prolyl - l - α - glutamyl - l - α - glutamyl - l - tyrosyl - l - leucine
CAS Number: 128270-60-0

Special Alerts:

The Editors of AHFS Drug Information (AHFS DI) and AHFS DI Essentials wish to inform you of an error in the monographs for bivalirudin 20:12.04.12 that resulted from an error in one of the cited references, the American College of Chest Physicians (ACCP) guideline on treatment and prevention of heparin-induced thrombocytopenia (Warkentin TE, Greinacher A, Koster A et al. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):340S-80S).^{10 25}

The error appears under the subhead Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery, in Dosage and Administration. In the second sentence under this subhead, the statement should read:

“During cardiopulmonary bypass, initially, 1 mg/kg by direct IV injection followed by 2.5 mg/kg per hour by continuous IV infusion has been used;^{10 24} if needed, additional direct IV doses of 0.1–0.5 mg/kg have been given to maintain a 2.5-fold or greater prolongation of the baseline ACT.²⁴ ”

The originally stated dosage of 0.1–0.5 mg for additional direct IV doses of bivalirudin is incorrect.²⁵

The following reflects the corrected version of this information, incorporating the change noted above.

Introduction

Anticoagulant; synthetic peptide analog of hirudin, an anticoagulant polypeptide found in the saliva of the medicinal leech (Hirudo medicinalis).^{1 2 3 4 5 6}

Uses for Angiomax

Acute Ischemic Complications of Percutaneous Coronary Intervention

Used with aspirin to reduce the risk of acute ischemic complications (e.g., death, MI, need for urgent revascularization procedures) in patients with unstable angina or non-ST-segment-elevation MI (i.e., non-ST-segment-elevation acute coronary syndromes) undergoing PCI, including percutaneous transluminal coronary angioplasty (PTCA).^{1 8 9 11 15 17}

American College of Chest Physicians (ACCP) recommends anticoagulant therapy (e.g., heparin, low molecular weight heparin, bivalirudin, fondaparinux) for all patients presenting with non-ST-segment-elevation acute coronary syndromes.¹⁷ ACCP suggests the use of bivalirudin in combination with clopidogrel over heparin for initial antithrombotic therapy in patients at moderate to high risk for an ischemic event and who are scheduled for very early coronary angiography (within <6 hours).¹⁷

Efficacy in patients with non-ST-segment-elevation acute coronary syndromes undergoing PCI similar to that of high-dose heparin.^{1 5}

Used with aspirin and “provisional” treatment with a GP IIb/IIIa-receptor inhibitor in selected patients undergoing PCI who have complications (i.e., prolonged ischemia, decreased perfusion [TIMI grade 0–2 flow] or slow reflow, dissection with decreased perfusion, new or suspected thrombus, persistent residual stenosis, distal embolism, unplanned or suboptimal stenting, side branch closure, abrupt closure, or other clinical instability).^{1 8 11 14 17} Efficacy in such patients similar to that of heparin and routine treatment with a GP IIb/IIIa-receptor inhibitor.^{1 8 9 11 14 16 17}

ACC, AHA, and the Society for Cardiovascular Angiography and Interventions (SCAI) suggest bivalirudin as an alternative to heparin and a GP IIb/IIIa-receptor inhibitor in patients undergoing PCI who are at low risk for ischemic complications.¹⁵

ACCP recommends either bivalirudin and provisional treatment with a GP IIb/IIIa-receptor inhibitor or heparin and routine treatment with a GP IIb/IIIa-receptor inhibitor in patients with non-ST-segment-elevation acute coronary syndromes undergoing PCI who are at low to moderate risk for ischemic complications.¹⁷

Safety and efficacy not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.¹

Heparin-induced Thrombocytopenia in Patients Undergoing PCI

Used with aspirin in patients undergoing PCI who have, or are at risk for, heparin-induced thrombocytopenia (HIT).^{1 10 15}

ACC/AHA/SCAI recommend bivalirudin or argatroban and ACCP recommends bivalirudin, argatroban, or lepirudin as a substitute for unfractionated heparin or low molecular weight heparin in patients with HIT undergoing PCI.^{10 15}

ACCP suggests use of a nonheparin anticoagulant over continued therapy with unfractionated or low molecular weight heparin in patients with a history of HIT (antibody negative) who require cardiac catheterization or PCI.¹⁰

Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery

Recommended as a substitute for heparin in patients with acute HIT (thrombocytopenic and HIT-antibody positive) who require cardiac surgery† (e.g., coronary artery bypass grafting [CABG]).^{10 24} ACCP recommends delaying surgery (if possible) until HIT antibodies are no longer detected or use of bivalirudin for intraoperative anticoagulation during cardiopulmonary bypass or “off-pump” cardiac surgery, provided special precautions to prevent blood stasis are followed.^{10 24 26} (See Patients with HIT Undergoing Cardiac Surgery under Cautions.)

Acute ST-Segment-Elevation MI

Used as an alternative to heparin in patients with acute ST-segment-elevation MI†.^{20 21 22} May be used in patients who have been pretreated with heparin and who are to undergo PCI; may also be used as an alternative to heparin in patients who have received fondaparinux in conjunction with a thrombolytic agent prior to PCI.²⁰

Angiomax Dosage and Administration

General

• 
  

  Manufacturer states that bivalirudin is intended for use concomitantly with aspirin 300–325 mg daily.¹ However, ACC/AHA/SCAI and ACCP recommend lower maintenance dosages of aspirin (e.g., 75–162 mg daily).^{15 17 18 19 20 21 23}

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by direct IV injection followed by IV infusion.¹ Do not administer IM.¹

Reconstitution

Reconstitute vial containing 250 mg of lyophilized bivalirudin with 5 mL of sterile water for injection (swirl gently) to provide a solution containing 50 mg/mL.¹

Discard any unused reconstituted solution.¹

Dilution

Dilute reconstituted solution in 50 mL of 5% dextrose or 0.9% sodium chloride injection to a final concentration of 5 mg/mL for direct IV injection and infusion.¹

For low-rate infusion, further dilute the 5-mg/mL solution in 500 mL of 5% dextrose or 0.9% sodium chloride injection to a final concentration of 0.5 mg/mL.^{1 7}

Dosage

Adults

Acute Ischemic Complications of PCI

IV

0.75 mg/kg (5-mg/mL solution) by direct IV injection immediately before PCI, followed by 1.75 mg/kg per hour (5-mg/mL solution) by continuous IV infusion for the duration of the procedure.¹ Obtain an activated clotting time (ACT) (as measured by a Hemochron device) 5 minutes after initial loading dose and administer an additional direct IV dose of 0.3 mg/kg if needed (e.g., if the ACT is <225 seconds).^{1 8}

May continue infusion for up to 4 hours after the procedure if necessary.¹ If needed, administer an additional IV infusion (0.5-mg/mL solution) at 0.2 mg/kg per hour for up to 20 hours.¹

Heparin-induced Thrombocytopenia in Patients Undergoing PCI

IV

0.75 mg/kg (5-mg/mL solution) by direct IV injection immediately before PCI, followed by 1.75 mg/kg per hour (5-mg/mL solution) by continuous IV infusion for the duration of the procedure.¹

May continue infusion for up to 4 hours after the procedure if necessary.¹ If needed, administer an additional IV infusion (0.5-mg/mL solution) at 0.2 mg/kg per hour for up to 20 hours.¹

Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery†

IV

During “off-pump” cardiac surgery (i.e., without cardiopulmonary bypass), 0.75 mg/kg by direct IV injection, followed by 1.75 mg/kg per hour by continuous IV infusion to maintain an ACT >300 seconds has been used.^{10 26}

During cardiopulmonary bypass, initially, 1 mg/kg by direct IV injection followed by 2.5 mg/kg per hour by continuous IV infusion has been used;^{10 24} if needed, additional direct IV doses of 0.1–0.5 mg/kg have been given to maintain a 2.5-fold or greater prolongation of the baseline ACT.²⁴ In addition, 50 mg of bivalirudin is added to the recirculating priming fluid of the cardiopulmonary bypass circuit.^{10 24}

Acute ST-Segment-Elevation MI†

IV

0.25 mg/kg by direct IV injection followed by 0.5 mg/kg per hour by continuous IV infusion for the first 12 hours, then 0.25 mg/kg per hour for the subsequent 36 hours, has been used.^{21 22} Obtain aPTT 12 and 24 hours after the initial dosage; adjust dosage if needed.²¹

Special Populations

Renal Impairment

Reduction of the initial loading dose not necessary in patients with moderate to severe renal impairment.^{1 7} Closely monitor activated clotting time (ACT) in patients with renal impairment.¹ Reduce infusion rate to 1 mg/kg per hour in patients with severe renal impairment (Cl_cr <30 mL/minute).¹ In dialysis-dependent patients, reduce off-dialysis infusion rate to 0.25 mg/kg per hour.¹

Cautions for Angiomax

Contraindications

• 
  

  Active major bleeding.¹

  
  


• 
  

  Known hypersensitivity to bivalirudin or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Hematologic Effects

Possible bleeding, especially at site of arterial puncture.^{1 7} Unexplained decreases in hematocrit, hemoglobin, or BP may indicate hemorrhage.¹

Discontinue if severe hemorrhage occurs.¹ Use with caution in patients with an increased risk of hemorrhage.^{1 7}

Increased risk of potentially fatal thrombosis during vascular brachytherapy procedures; use caution.¹ Assess catheter function frequently by attempting to aspirate blood, and ensure patency by repeated flushing.¹ Minimize conditions promoting stasis within the catheter or circulatory system.^{1 10}

Sensitivity Reactions

Hypersensitivity

Positive bivalirudin antibody tests found rarely in clinical studies; however, no allergic or anaphylactic reactions reported.^{1 7}

General Precautions

Factors Increasing Risk of Hemorrhage

Increased risk of major bleeding events with concomitant heparin, warfarin, thrombolytic, or GP IIb/IIIa-receptor inhibitor therapy in clinical trials.¹ (See Common Adverse Effects and see Specific Drugs under Interactions.) No experience with concomitant administration of plasma expanders such as dextran.¹

Use with caution in patients with disease states associated with increased risk of hemorrhage.¹

Brachytherapy Procedures

Use with caution during vascular brachytherapy procedures because of an increased risk of potentially fatal thrombosis.¹

Patients with HIT Undergoing Cardiac Surgery

Possible formation of clots due to degradation of bivalirudin in areas of blood stasis; special maneuvers needed to avoid stasis within the cardiopulmonary bypass circuit during and after cardiac surgery.^{10 24 26} Avoid use of cardiotomy suction; also avoid use of patient blood to test graft patency or for cardioplegia solutions.^{10 24 26}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether bivalirudin is distributed into milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults.^{1 7}

Renal Impairment

Dosage reduction recommended in patients with moderate to severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Major hemorrhagic events less frequent with bivalirudin with or without provisional GP IIb/IIIa-receptor inhibitor therapy (2.3%) compared with unfractionated heparin and routine GP IIb/IIIa-receptor inhibitor therapy (4%).¹

Nonhemorrhagic effects in patients with unstable angina undergoing PTCA: Back pain,¹ pain (unspecified),¹ nausea,¹ headache,¹ hypotension,¹ injection site pain,¹ insomnia,¹ hypertension,¹ vomiting,¹ pelvic pain,¹ anxiety,¹ bradycardia,¹ dyspepsia,¹ abdominal pain,¹ fever,¹ nervousness,¹ urinary retention.¹

Nonhemorrhagic effects in patients undergoing PCI and receiving provisional therapy with a GP IIb/IIIa-receptor inhibitor: Back pain, angina pectoris,¹ pain (unspecified),¹ hypotension,¹ nausea,¹ injection site pain,¹ headache,¹ chest pain.¹

Interactions for Angiomax

Specific Drugs

Drug	Interaction	Comments
Aspirin	Increased risk of hemorrhage13
GP IIb/IIIa-receptor inhibitors	Increased risk of hemorrhage1
Heparin	Increased risk of hemorrhage1
Heparin, low molecular weight	No apparent pharmacodynamic interaction13	Limited data; safety and efficacy of combination therapy not established13
Plasma-volume expanders (e.g., dextran)	No experience with concomitant therapy1
Thrombolytic agents	Increased risk of hemorrhage1
Ticlopidine	No apparent pharmacodynamic interaction13	Limited data; safety and efficacy of combination therapy not established13
Warfarin	Increased risk of hemorrhage1

Angiomax Pharmacokinetics

Absorption

Onset

Immediate anticoagulant effect.¹

Duration

Effects are dose- and concentration-dependent and reversible; thrombin slowly cleaves the bivalirudin-Arg₃-Pro₄ bond, which results in recovery of the thrombin active site function.^{1 3 4} Coagulation times return to normal approximately 1–2 hours after cessation of infusion.^{1 7}

Distribution

Extent

Not known whether the drug is distributed into human milk.¹

Plasma Protein Binding

Does not bind to plasma proteins (other than thrombin).¹

Elimination

Metabolism

Cleared from the plasma by a combination of renal mechanisms and intracellular proteolysis.^{1 b}

Elimination Route

Approximately 20% of unchanged bivalirudin is cleared renally, and the remainder presumably undergoes intracellular proteolysis.^b

Half-life

22 minutes.¹

Special Populations

In patients with mild renal impairment (GFR of 60–89 mL/minute), half-life is 25 minutes.¹

In patients with moderate renal impairment (GFR of 30–59 mL/minute), half-life is 34 minutes.¹

In patients with severe renal impairment (GFR of 10–29 mL/minute), half-life is 57 minutes.¹

In dialysis-dependent patients, off-dialysis half-life is 3.5 hours.¹

Total body clearance reduced by about 20% in patients with moderate to severe renal impairment and by 80% in dialysis-dependent patients.¹

Approximately 25% of drug removed by hemodialysis.¹

Stability

Storage

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).¹

Reconstituted solution (50 mg/mL) may be stored at 2–8°C for up to 24 hours.¹

Diluted IV solutions (0.5–5 mg/mL) are stable at room temperature for up to 24 hours.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility¹

Compatible
Dextrose 5% in water
Sodium chloride 0.9%

Drug Compatibility^HID

Y-Site CompatibilityHID

Compatible
Abciximab
Alfentanil HCl
Amikacin sulfate
Aminophylline
Ampicillin sodium
Ampicillin sodium-sulbactam sodium
Azithromycin
Aztreonam
Bretylium tosylate
Bumetanide
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Cefepime HCl
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Cimetidine HCl
Ciprofloxacin
Clindamycin phosphate
Co-trimoxazole
Dexamethasone sodium phosphate
Digoxin
Diltiazem HCl
Diphenhydramine HCl
Dobutamine HCl
Dopamine HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Ephedrine sulfate
Epinephrine HCl
Epoprostenol sodium
Eptifibatide
Erythromycin lactobionate
Esmolol HCl
Famotidine
Fentanyl citrate
Fluconazole
Furosemide
Gentamicin sulfate
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium succinate
Hydromorphone HCl
Isoproterenol HCl
Labetalol HCl
Levofloxacin
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ActionsActions

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  Specific and reversible direct thrombin inhibitor that binds to circulating and clot-bound thrombin.^{1 2 3 4}

  
  


• 
  

  Inhibition of thrombin prevents various steps in the coagulation process (e.g., activation of factors V, VIII, and XIII; conversion of fibrinogen to fibrin; platelet activation and aggregation).^{1 2 3 4}

  
  


• 
  

  Prolongs activated clotting time (ACT), aPTT, thrombin time (TT), and PT.^{1 7}

  
  

Advice to Patients

• 
  

  Importance of patients reporting any signs of bleeding (e.g., bruising, petechiae, hematuria) to clinicians immediately.¹

  
  


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  Importance of patients informing clinicians of history of bleeding disorders or impaired renal function.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant diseases.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Bivalirudin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	250 mg	Angiomax	Medicines Company

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 25, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. The Medicines Company. Angiomax (bivalirudin) for injection prescribing information. Cambridge, MA; 2005 Dec 6.

2. Haines ST, Bussey HI. Thrombosis and the pharmacology of antithrombotic agents. Ann Pharmacother. 1995; 29:892-905. [IDIS 353388] [PubMed 8547739]

3. Stringer KA, Lindenfeld J. Hirudins: antithrombin anticoagulants. Ann Pharmacother. 1992; 26:1535-40. [IDIS 306624] [PubMed 1482812]

4. Bates SM, Weitz JI. Direct thrombin inhibitors for treatment of arterial thrombosis: potential differences between bivalirudin and hirudin. Am J Cardiol. 1998; 82:12-8P.

5. Bittl JA, Strony J, Brinker JA et al for the Hirulog Angioplasty Study investigators. Treatment with bivalirudin (hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. N Engl J Med. 1995; 333:764-9. [IDIS 353197] [PubMed 7643883]

6. Bittl JA, Feit F for Hirulog Angioplasty Study investigators. A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Am J Cardiol. 1998; 82:43-9P. [PubMed 9671007]

7. The Medicines Company, Cambridge, MA: Personal communication.

8. Lincoff AM, Bittl JA, Harrington RA et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003; 289:853-63. [IDIS 493155] [PubMed 12588269]

9. Saw J, Lincoff M, DeSmet W et al. Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade: a REPLACE-2 substudy. J Am Coll Cardiol. 2004; 44:1194-9. [IDIS 524399] [PubMed 15364319]

10. Warkentin TE, Greinacher A, Koster A et al. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed) Chest. 2008; 133 (Suppl):340S-80S

11. Popma JJ, Berger P, Ohman EM et al. Antithrombotic therapy in patients undergoing percutaneous coronary intervention. Chest. 2001; 119(Suppl):321S-36S.

12. Harrington RA, Becker RC, Ezekowitz M et al. Antithrombotic therapy in coronary artery disease. Chest. 2004; 126:513S-48S. [IDIS 523845] [PubMed 15383483]

13. The Medicines Company. Angiomax (bivalirudin) for injection prescribing information. Cambridge, MA; 2002 Jun 18.

14. Lincoff, AM, Kleiman NS, Kereiakes DJ et al. Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial. JAMA. 2004; 292:696-703.

15. Smith SC, Feldman TE, Hirschfeld JW et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Revise the 2001 Guidelines for Percutaneous Coronary Intervention). 2005. Available at the American College of Cardiology web site.

16. Lansky AJ, Hochman JS, Ward PA et al. Percutaneous coronary intervention and adjunctive pharmacotherapy in women: a statement for healthcare professionals from the American Heart Association. Circulation. 2005; 111:940-5. [PubMed 15687113]

17. Harrington RA, Becker RC, Cannon CP et al. Antithrombotic therapy for non-ST-segment elevation acute coronary syndromes.American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133:670S-707S. [PubMed 18574276]

18. King SB, Smith SC, Hirshfeld JW et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008; 51:172-9. [PubMed 18191745]

19. Becker RC, Meade TW, Berger PB et al. The primary and secondary prevention of coronary artery disease: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl): 776S-814S. [PubMed 18574278]

20. Antman EM, Hand M, Armstrong PW et al. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction. J Am Coll Cardiol. 2008; 51:210-47. [PubMed 18191746]

21. Goodman SG, Menon V, Cannon CP et al. Acute ST-segment elevation myocardial infarction: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):708S-75S. [PubMed 18574277]

22. Schulman S, Beyth RJ, Kearon C et al. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):257S-98S. [PubMed 18574268]

23. Anderson JL, Adams CD, Antman EM et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction). Available at ACC website. Accessed 2008 Oct 15.

24. Koster A, Dyke CM, Aldea G et al. Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON trial. Ann Thorac Surg. 2007; 83:572-7.

25. Lewis SZ (American College of Chest Physicians, Northbrook, IL): Personal communication. 2011 Mar 15.

26. Dyke CM, Aldea G, Koster A et al. Off-pump coronary artery bypass with bivalirudin for patients with heparin-induced thrombocytopenia or antiplatelet factor four/heparin antibodies. Ann Thorac Surg. 2007; 84:836-40.

b. Robson R, White H, Aylward P et al. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002; 71:433-39. [PubMed 12087346]

HID. Trissel LA. Handbook on injectable drugs. 14th ed; Bethesda, MD: American Society of Health-System Pharmacists; 2007:207-13.

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• Angiomax Side Effects (in more detail)
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