clarithromycin (Biaxin)

Macrolide Antibiotics

Clarithromycin is part of the Macrolide Antibiotics class and treats Ear Infection, Bacterial Infection, Lower Respiratory Infection, and other conditions. Macrolide antibiotics are used to treat bacterials infections including sinus infections, pneumonia, lower respiratory infections, upper respiratory infections, skin infections, eye infections, ear infections, and acne. They work by killing the bacteria causing the infection. Clarithromycin is available in both brand and generic forms.

What is clarithromycin?


Commonly Used Brand Name(s): Biaxin, Biaxin Filmtab, Biaxin XL

Therapeutic Classification: Antibiotic

Chemical Classification: Macrolide

Clarithromycin is used to treat bacterial infections in many different parts of the body. It is also used in combination with other medicines to treat duodenal ulcers caused by H. pylori. This medicine is also used to prevent and treat Mycobacterium avium complex (MAC) infection.

Clarithromycin belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

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.

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

You may take this medicine with meals or milk or on an empty stomach. However, clarithromycin extended release tablets should be taken with food.

If you are using the extended-release tablets:

  • Swallow the tablet whole. Do not break, crush, or chew it.
  • While taking the extended-release form of this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.

Measure the oral liquid with a marked measuring spoon, syringe, or cup. The average household teaspoon may not hold the right amount of liquid. Shake the bottle of medicine well just before taking each dose.

If you are taking clarithromycin and zidovudine, these medicines should be taken at least 2 hours apart.

Keep using the medicine for the full time of treatment, even if you or your child begin to feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

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 (extended-release tablets):
    • For bacterial infections:
      • Adults—1000 milligrams (mg) once a day for 7 to 14 days.
      • Children—Use and dose must be determined by your doctor.
    • For community-acquired pneumonia:
      • Adults—1000 milligrams (mg) once a day for 7 days.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (suspension and tablets):
    • For bacterial infections:
      • Adults—250 to 500 milligrams (mg) every twelve hours for 7 to 14 days.
      • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight every twelve hours for 10 days.
      • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
    • For community-acquired pneumonia:
      • Adults—250 milligrams (mg) every twelve hours for 7 to 14 days.
      • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight every twelve hours for 10 days.
      • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
    • For prevention or treatment of Mycobacterium avium complex (MAC) infection:
      • Adults—500 milligrams (mg) two times a day.
      • Children 20 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight, up to 500 mg, two times a day.
      • Children younger than 20 months of age—Use and dose must be determined by your doctor.
    • For treatment of ulcers associated with H. pylori:
      • Adults—500 milligrams (mg) two or three times a day for 10 or 14 days, in combination with omeprazole or ranitidine bismuth sulfate; 500 mg every twelve hours in combination with amoxicillin and lansoprazole for 10 or 14 days; or 500 mg every twelve hours in combination with amoxicillin and omeprazole for 10 days.
      • 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

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.

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

Do not refrigerate or freeze the oral liquid. Throw away any unused mixed medicine after 14 days.

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 clarithromycin to treat bacterial infections in children younger than 6 months of age, and to prevent and treat Mycobacterium avium complex in children younger than 20 months of age. Safety and efficacy have not been established in these age groups.

Geriatric

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

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Drug Interactions

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.

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.

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.

Other Interactions

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.

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:

  • Cholestatic jaundice, history of or
  • Heart rhythm problems (e.g., QT prolongation, Torsades de Pointes, ventricular arrhythmia), history of or
  • Liver disease, history of—Should not be used in patients with a history of these conditions caused by clarithromycin.
  • Decreased kidney function or
  • Porphyria (enzyme problem), history of—Clarithromycin together with ranitidine bismuth citrate should not be used in patients with these conditions.
  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Do not use this medicine if you or your child are also using astemizole (Hismanal®), cisapride (Propulsid®), lovastatin (Mevacor®), pimozide (Orap®), simvastatin (Zocor®), terfenadine (Seldane®), or certain ergot medicines (such as dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®). If you have kidney or liver disease, do not take both this medicine and colchicine (Colcrys®). Using these medicines together may increase risk for more serious side effects.

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

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, tell your doctor right away.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you or your child stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

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

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.

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