Clarithromycin Extended Release
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Questions & Answers
Side Effects & Adverse Reactions
CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE. IF PREGNANCY OCCURS WHILE TAKING THIS DRUG, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. CLARITHROMYCIN HAS DEMONSTRATED ADVERSE EFFECTS OF PREGNANCY OUTCOME AND/OR EMBRYO-FETAL DEVELOPMENT IN MONKEYS, RATS, MICE, AND RABBITS AT DOSES THAT PRODUCED PLASMA LEVELS 2 TO 17 TIMES THE SERUM LEVELS ACHIEVED IN HUMANS TREATED AT THE MAXIMUM RECOMMENDED HUMAN DOSES. (See PRECAUTIONS - Pregnancy.)
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clarithromycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients. (See PRECAUTIONS.)
For information about warnings of other drugs indicated in combination with clarithromycin, refer to the WARNINGS section of their package inserts.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets and other antibacterial drugs, clarithromycin extended-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.
History
There is currently no drug history available for this drug.
Other Information
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:
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.
Clarithromycin is available as extended-release tablets.
Each yellow oval-shaped film-coated clarithromycin extended-release tablet for oral administration contains 1 gram clarithromycin, USP and the following inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, propylene glycol, shellac, sodium stearyl fumarate, talc, titanium dioxide.
Meets USP Dissolution Test 3.
Sources
Clarithromycin Extended Release Manufacturers
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Ranbaxy Pharmaceuticals Inc.
![Clarithromycin Extended Release (Clarithromycin) Tablet, Film Coated, Extended Release [Ranbaxy Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clarithromycin Extended Release | Ranbaxy Pharmaceuticals Inc.
Clarithromycin extended-release tablets should be taken with food.
Clarithromycin extended-release tablets should be swallowed whole and not chewed, broken or crushed.
ADULT DOSAGE GUIDELINES Clarithromycin Extended-Release Tablets Infection Dosage (q24h) Duration (days) Acute maxillary sinusitis due to 1 gram 14 H. influenzae M. catarrhalis S. pneumoniae Acute exacerbation of chronic bronchitis due to H. influenzae 1 gram 7 H. parainfluenzae 1 gram 7 M. catarrhalis 1 gram 7 S. pneumoniae 1 gram 7 Community-Acquired Pneumonia due to H. influenzae 1 gram 7 H. parainfluenzae 1 gram 7 M. catarrhalis 1 gram 7 S. pneumoniae 1 gram 7 C. pneumoniae 1 gram 7 M. pneumoniae 1 gram 7
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