Biaxin, Biaxin XL

DRUG DESCRIPTION

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

BIAXIN® Filmtab® (clarithromycin) 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; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • uneven heartbeats, chest pain, shortness of breath;
  • diarrhea that is watery or bloody;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and...

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 or 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 severe dizziness, fainting) that require immediate medical...

Read All Potential Precautions of Biaxin, Biaxin XL »


Biaxin, Biaxin XL Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, vomiting, stomach upset, changes in taste, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: hearing loss, mental/mood changes.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: new signs of infection (e.g., fever, persistent sore throat), muscle weakness, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes or skin, change in the amount of urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 or 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 severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using clarithromycin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using clarithromycin safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Based on information for similar drugs, this medication may pass into breast milk. Therefore, consult your doctor before breast-feeding.


Biaxin, Biaxin XL Patient Information Including Side Effects

Brand Names: Biaxin, Biaxin XL, Biaxin XL-Pak

Generic Name: clarithromycin (Pronunciation: kla RITH roe MYE sin)

  • What is clarithromycin (Biaxin, Biaxin XL)?
  • What are the possible side effects of clarithromycin (Biaxin, Biaxin XL)?
  • What is the most important information I should know about clarithromycin (Biaxin, Biaxin XL)?
  • What should I discuss with my healthcare provider before taking clarithromycin (Biaxin, Biaxin XL)?
  • How should I take clarithromycin (Biaxin, Biaxin XL)?
  • What happens if I miss a dose (Biaxin, Biaxin XL)?
  • What happens if I overdose (Biaxin, Biaxin XL)?
  • What should I avoid while taking clarithromycin (Biaxin, Biaxin XL)?
  • What other drugs will affect clarithromycin (Biaxin, Biaxin XL)?
  • Where can I get more information?

What is clarithromycin (Biaxin, Biaxin XL)?

Clarithromycin is in a group of drugs called macrolide antibiotics. Clarithromycin fights bacteria in your body.

Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori.

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

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • uneven heartbeats, chest pain, shortness of breath;
  • diarrhea that is watery or bloody;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • problems with your hearing.

Less serious side effects may include:

  • mild stomach pain, nausea, vomiting, diarrhea, upset stomach;
  • unusual or unpleasant taste in your mouth;
  • tooth discoloration;
  • dizziness, headache, anxiety, confusion;
  • skin rash; or
  • vaginal itching or discharge.

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 is the most important information I should know about clarithromycin (Biaxin, Biaxin XL)?

Do not use clarithromycin if you are also using any of the drugs listed below. They can interact with clarithromycin and cause life-threatening heart rhythm disorders:

  • cisapride (Propulsid);
  • pimozide (Orap); or
  • ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray).

Take this medication for the entire length of time prescribed by your doctor. Clarithromycin is usually given for 7 to 14 days (or longer when treating stomach ulcer). Your symptoms may get better before the infection is completely treated. Clarithromycin will not treat a viral infection such as the common cold or flu.

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