Biaxin XL

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|Biaxin XL

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CLARITHROMYCIN (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Biaxin
  • Biaxin XL

In Canada—

  • Biaxin

Category

  • Antibacterial, systemic
  • antimycobacterial

Description

Clarithromycin (kla-RITH-roe-mye-sin) is used to treat bacterial infections in many different parts of the body. It works by killing bacteria or preventing their growth. It is also used to treat and prevent Mycobacterium avium complex (MAC) infection, and to treat duodenal ulcers caused by Helicobacter pylori . However, this medicine will not work for colds, flu, or other virus infections. Clarithromycin also may be used for other problems as determined by your doctor.

Clarithromycin is available only with your doctor"s prescription, in the following dosage forms:

  • Oral
  • Oral suspension (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S.)

Before Using This Medicine

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 clarithromycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clarithromycin or to any related medicines, such as erythromycin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Clarithromycin has not been studied in pregnant women. However, studies in animals have shown that clarithromycin causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Clarithromycin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Mothers who are taking this medicine and who wish to breast feed should discuss this with their doctor.

Children—Studies on this medicine have not been done in children up to 6 months of age. In effective doses, the medicine has not been shown to cause different side effects or problems in children over the age of 6 months than it does in adults.

Older adults—This medicine has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other 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 clarithromycin, it is especially important that your health care professional know if you are taking any of the following:

  • Anticoagulants (blood thinners such as warfarin [e.g., Coumadin]) or
  • Astemizole (e.g., Hismanal) or
  • Carbamazepine (e.g., Tegretol) or
  • Cisapride (e.g., Propulsid) or
  • Colchicine (medicine used to treat gout) or
  • Digoxin (e.g., Lanoxin) or
  • Disopyramide (e.g., Norpace) or
  • Pimozide (e.g., Orap) or
  • Quinidine (e.g., Quinaglute, Quinidex) or
  • Terfanadine (e.g., Seldane) or
  • Theophylline (e.g., Theodur, Slo-Bid)—Clarithromycin may increase the chance of side effects of these medicines; astemizole, cisapride, pimozide, and terfenadine should not be taken with clarithromycin
  • Dihydroergotamine (e.g., Migranal) or
  • Ergotamine (e.g., Ergomar)—Clarithromycin can cause these medicines to build up in your body and cause serious side effects. These medicines should not be taken with clarithromycin.
  • Omeprazole (e.g., Prilosec)—Clarithromycin may cause the amount of omeprazole in your body to increase when taken at the same time.
  • Rifabutin (e.g., Mycobutin) or
  • Rifampin (e.g., Rifadin)—Rifabutin or rifampin may decrease the amount of clarithromycin in the blood
  • Sildenafil (e.g., Viagra)—Clarithromycin may cause increases in sildenafil concentrations in the body. Your doctor may consider lowering your sildenafil dose.
  • Zidovudine (e.g., Retrovir)—Clarithromycin may decrease the amount of zidovudine in the blood

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

  • Kidney disease—Patients with severe kidney disease may have an increased chance of side effects.

Proper Use of This Medicine

Clarithromycin may be taken with meals or milk or on an empty stomach, extended release tablets should be taken with food.

If you are taking clarithromycin and zidovudine, these medicines should be taken at least 4 hours apart.

To help clear up your infection completely, keep taking clarithromycin for the full time of treatment , even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

If you are using clarithromycin oral suspension , use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Dosing—The dose of clarithromycin 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 clarithromycin. Your dose may be different if you have kidney disease. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine.

  • For oral dosage forms (suspension and tablets):
    • For bacterial infections:
      • For oral dosage form ( suspension and tablets):
      • Adults and teenagers—250 to 500 milligrams (mg) every twelve hours for seven to fourteen days.
      • Children 6 months of age and older—7.5 mg per kilogram (kg) (3.4 mg per pound) of body weight every twelve hours for ten days.
      • Infants up to 6 months of age—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (extended release tablets)
      • Adults and teenagers— 1000 milligrams (mg) once a day for seven to fourteen days.
    • For Community-acquired pneumonia
      For oral dosage form ( suspension and tablets):
      • Adults and teenagers—250 to 500 milligrams (mg) every twelve hours for seven to fourteen days.
      • Children 6 months of age and older—7.5 mg per kilogram (kg) (3.4 mg per pound) of body weight every twelve hours for ten days.

      For long-acting oral dosage form (extended-release tablets):
      • Adults and teenagers—1000 milligrams (mg) once a day for seven days
    • For prevention or treatment of Mycobacterium avium complex (MAC) infection:
      • For oral dosage form ( suspension and tablets):
      • Adults and teenagers—500 mg two times a day.
      • Children 6 months of age and older—7.5 mg per kg (3.4 mg per pound) of body weight, up to 500 mg, two times a day.
      • Infants up to 6 months of age—Use and dose must be determined by your doctor.
    • For treatment of ulcers associated with Helicobacter pylori :
      • For oral dosage form ( suspension and tablets):
      • Adults and teenagers—500 mg three times a day for fourteen days, in combination with omeprazole or ranitidine bismuth sulfate; or 500 mg every twelve hours in combination with amoxicillin and lansoprazole for fourteen days.
      • Infants and 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—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
  • Do not store suspension in the refrigerator.

Precautions While Using This Medicine

Clarithromycin should not be taken with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, terfenadine . Doing so may increase the risk of serious side effects affecting the heart.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Side Effects of This Medicine

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:

Incidence less frequent

Cough; fever or chills; hoarseness; lower back or side pain; painful or difficult urination

Rare

Abdominal tenderness; fever with or without chills; nausea and vomiting; severe abdominal or stomach cramps and pain; shortness of breath; skin rash and itching; unusual bleeding or bruising; watery and severe diarrhea, which may also be bloody; yellow eyes or skin

Incidence not known

Abdominal pain; anxiety; black, tarry stools; blistering, peeling, loosening of skin; blurred vision; chest pain or discomfort; chills; clay-colored stools; cold sweats; coma; confusion; confusion about identity, place, and time; cool pale skin; dark urine; depression; difficulty swallowing; dizziness; fainting; fast, pounding, or irregular heartbeat or pulse; feeling of unreality; feeling that others are watching you or controlling your behavior; feeling that others can hear your thoughts; feeling, seeing, or hearing things that are not there; hives; increased hunger; irregular heartbeat; joint or muscle pain; light-colored stools; loss of appetite; nervousness; nightmares; palpitations; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; recurrent fainting; red irritated eyes; red skin lesions, often with a purple center; redness, swelling, or soreness of tongue; seeing, hearing, or feeling things that are not there; seizures; sense of detachment from self or body; severe mood or mental changes; shakiness; slow heartbeat; slurred speech; sore throat; sores, ulcers, or white spots in mouth or on lips; sudden death; swollen glands; tightness in chest; unpleasant breath odor; unusual behavior; unusual tiredness or weakness; vomiting of blood; wheezing

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Less common

Acid or sour stomach; belching; bloated, full feeling; change in sensation of taste; diarrhea (mild); excess air or gas in stomach or intestines; headache; heartburn ; indigestion; passing gas; stomach discomfort, upset, or pain

Incidence not known

Alterations of sense of smell; continuing ringing or buzzing or other unexplained noise in the ears; fear; feeling of constant movement of self or surroundings; hearing loss; lightheadedness; mental depression; mood or mental changes; sensation of spinning; shakiness in legs, arms, hands, feet; skin eruptions; sleeplessness; sore mouth or tongue; swelling or inflammation of the mouth; taste loss; tongue discoloration; tooth discoloration; trembling or shaking of hands or feet; trouble sleeping; unable to sleep; weight loss; white patches in mouth and/or on tongue

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, clarithromycin is used in certain patients with the following medical condition:

  • Legionnaires" disease

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 01/06/2006

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