Biaxin

Generic Name: clarithromycin (Oral route)

kla-rith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

• Biaxin
• Biaxin Filmtab
• Biaxin XL

Available Dosage Forms:

• Powder for Suspension
• Tablet
• Tablet, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For Biaxin

Clarithromycin 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.

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

Before Using Biaxin

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

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.

Geriatric

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.

Pregnancy

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

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.

• Astemizole
• Bepridil
• Cisapride
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Levomethadyl
• Mesoridazine
• Methylergonovine
• Methysergide
• Pimozide
• Ranolazine
• Silodosin
• Terfenadine
• Thioridazine
• Tolvaptan
• Ziprasidone

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.

• Acecainide
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Aprepitant
• Aprindine
• Arsenic Trioxide
• Atazanavir
• Atorvastatin
• Azimilide
• Bretylium
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Colchicine
• Dasatinib
• Desipramine
• Dibenzepin
• Digoxin
• Disopyramide
• Dofetilide
• Dolasetron
• Doxepin
• Droperidol
• Enflurane
• Erythromycin
• Etravirine
• Everolimus
• Fentanyl
• Flecainide
• Fluconazole
• Fluoxetine
• Fluticasone
• Foscarnet
• Gemifloxacin
• Halofantrine
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Iloperidone
• Imipramine
• Isoflurane
• Isradipine
• Ixabepilone
• Lapatinib
• Lidoflazine
• Lorcainide
• Lovastatin
• Mefloquine
• Nifedipine
• Nilotinib
• Nortriptyline
• Octreotide
• Pazopanib
• Pentamidine
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Rifabutin
• Risperidone
• Romidepsin
• Salmeterol
• Sematilide
• Sertindole
• Simvastatin
• Sirolimus
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sultopride
• Sunitinib
• Tadalafil
• Tamsulosin
• Tedisamil
• Telithromycin
• Temsirolimus
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Vasopressin
• Venlafaxine
• Vinorelbine
• Voriconazole
• Zolmitriptan
• Zotepine

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.

• Acenocoumarol
• Alfentanil
• Alprazolam
• Bromocriptine
• Carbamazepine
• Cilostazol
• Conjugated Estrogens
• Cyclosporine
• Darunavir
• Delavirdine
• Diazepam
• Efavirenz
• Esterified Estrogens
• Estradiol
• Estriol
• Estrone
• Estropipate
• Fesoterodine
• Glipizide
• Glyburide
• Hexobarbital
• Indinavir
• Itraconazole
• Lopinavir
• Methylprednisolone
• Midazolam
• Nevirapine
• Paroxetine
• Phenytoin
• Prednisone
• Repaglinide
• Rifapentine
• Ritonavir
• Saquinavir
• Tacrolimus
• Tipranavir
• Tolterodine
• Trazodone
• Triazolam
• Verapamil
• Warfarin

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:

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

Proper Use of clarithromycin

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

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 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 forms (suspension and tablets):
  • For bacterial infections:
    • 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 community-acquired pneumonia:
      • 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 prevention or treatment of Mycobacterium avium complex (MAC) infection:
      • 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:
      • 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.
  • For long-acting oral dosage form (extended release tablets)
    • For bacterial infections:
      • Adults and teenagers— 1000 milligrams (mg) once a day for seven to fourteen days.
    • For community-acquired pneumonia:
      • Adults and teenagers—1000 milligrams (mg) once a day for seven days

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.

Do not store suspension in the refrigerator.

Precautions While Using Biaxin

Clarithromycin should not be taken with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or 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.

Biaxin 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:

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

• 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

• Abdominal pain
• anxiety
• black, tarry stools
• blistering, peeling, loosening of skin
• blurred vision
• chest pain or discomfort
• chills
• clay-colored stools
• 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

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:

• 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

• 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 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.

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