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Biaxin

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Biaxin, Biaxin XL

BIAXIN® Filmtab®
(clarithromycin) Tablets, USP)

BIAXIN® XL Filmtab®
(clarithromycin) Extended-release Tablets

BIAXIN® Granules
(clarithromycin) for Oral Suspension, USP

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BIAXIN and other antibacterial drugs, BIAXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Biaxin, Biaxin XL

DRUG DESCRIPTION

Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. The structural formula is:

BIAXIN® Filmtab® (clarithromycin tablets, USP) Structural Formula Illustration

Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.

BIAXIN is available as immediate-release tablets, extended-release tablets, and granules for oral suspension.

Each yellow oval film-coated immediate-release BIAXIN tablet (clarithromycin tablets, USP) contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients:

250 mg tablets: hypromellose, hydroxypropyl cellulose, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, sorbic acid, sorbitan monooleate, stearic acid, talc, titanium dioxide, and vanillin.

500 mg tablets: hypromellose, hydroxypropyl cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sorbic acid, sorbitan monooleate, titanium dioxide, and vanillin.

Each yellow oval film-coated BIAXIN XL tablet (clarithromycin extended-release tablets) contains 500 mg of clarithromycin and the following inactive ingredients: cellulosic polymers, D&C Yellow No. 10, lactose monohydrate, magnesium stearate, propylene glycol, sorbic acid, sorbitan monooleate, talc, titanium dioxide, and vanillin.

After constitution, each 5 mL of BIAXIN suspension (clarithromycin for oral suspension, USP) contains 125 mg or 250 mg of clarithromycin. Each bottle of BIAXIN granules contains 1250 mg (50 mL size), 2500 mg (50 and 100 mL sizes) or 5000 mg (100 mL size) of clarithromycin and the following inactive ingredients: carbomer, castor oil, citric acid, hypromellose phthalate, maltodextrin, potassium sorbate, povidone, silicon dioxide, sucrose, xanthan gum, titanium dioxide and fruit punch flavor.

What are the possible side effects of clarithromycin (Biaxin, Biaxin XL, Biaxin XL-Pak)?

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:

  • uneven heartbeats, chest pain, shortness of breath;
  • diarrhea that is watery or bloody;
  • problems with your hearing; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in...

Read All Potential Side Effects and See Pictures of Biaxin, Biaxin XL »

What are the precautions when taking clarithromycin (Biaxin, Biaxin XL)?

Before taking clarithromycin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (e.g., erythromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including liver problems with past clarithromycin use), kidney disease, a certain type of muscle disease (myasthenia gravis).

Clarithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as...

Read All Potential Precautions of Biaxin, Biaxin XL »

Last reviewed on RxList: 9/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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