Clarithromycin (Clarithromycin) - Summary

CLARITHROMYCIN SUMMARY

Clarithromycin is a semi-synthetic macrolide antibiotic.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin extended-release tablets, USP and other antibacterial drugs, clarithromycin extended-release tablets, USP 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.

Adults (Clarithromycin extended-release tablets, USP)

Clarithromycin extended-release tablets, USP are indicated for the treatment of adults with mild to moderate infection caused by susceptible strains of the designated microorganisms in the conditions listed below:

Acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.

Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae (TWAR), or Mycoplasma pneumoniae.

THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF CLARITHROMYCIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.

See all Clarithromycin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Clarithromycin

Cethromycin versus clarithromycin for community-acquired pneumonia: comparative efficacy and safety outcomes from two double-blinded, randomized, parallel-group, multicenter, multinational noninferiority studies. [2012]
Community-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem...

Clarithromycin therapy for patients with cystic fibrosis: a randomized controlled trial. [2012]
The clinically significant actions of oral azithromycin in modifying progressive cystic fibrosis (CF) lung disease have been well documented. In vitro and clinical data suggests that clarithromycin has immunomodulatory properties similar to other 14-member macrolides, however two previously reported short term, open label trials of clairthromycin in small numbers of patients with CF failed to show significant benefits in modifying lung function or inflammation...

Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. [2011.10]
OBJECTIVE: Along with conventional non-surgical periodontal therapy (NSPT) systemic antimicrobials may provide more effective treatment for chronic periodontitis by targeting tissue-invasive bacteria. The aim of this randomized, placebo-controlled, double-masked clinical trial was to evaluate the adjunctive effects of oral clarithromycin (CLM) to non-surgical periodontal therapy for chronic periodontitis... CONCLUSIONS: The utilisation of CLM in combination with SRP improves the efficacy of NSPT in reducing PD, improving CAL and in lessening microbial loads. Hence, CLM may be beneficial in the non-surgical treatment regimen of chronic periodontitis. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

A comparison between the effectiveness of erythromycin, single-dose clarithromycin and topical fusidic acid in the treatment of erythrasma. [2011.09.18]
Abstract Although erythrasma is a superficial skin infection, there is no consensus on the treatment model of erythrasma... Conclusion: Topical fusidic acid proved to be the most effective treatment; however, clarithromycin therapy may be an alternative regimen in the treatment of erythrasma because of its efficiency and better patient's compliance.

Inhibition of cytochrome P450 3A by clarithromycin uniformly affects the pharmacokinetics and pharmacodynamics of oxycodone in young and elderly volunteers. [2011.06]
The aim of this study was to investigate the effect of the cytochrome P450 3A4 inhibitor clarithromycin on the pharmacokinetics and pharmacodynamics of oral oxycodone in young and elderly subjects.Although the pharmacological response to oxycodone was not significantly influenced by clarithromycin, dose reductions may be necessary in the most sensitive patients to avoid adverse effects when oxycodone is used concomitantly with clarithromycin.

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Clinical Trials Related to Clarithromycin

Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis [Completed]
To compare the efficacy of a 5-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID) in the treatment of acute bacterial exacerbation of chronic bronchitis.

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets [Completed]
The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M. D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 250 mg tablets are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered under fasted conditions.

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State [Completed]
The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M. D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fed conditions.

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State [Completed]
The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M. D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fasting conditions.

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis [Completed]
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).

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Reports of Suspected Clarithromycin Side Effects

Drug Interaction (138),  Dyspnoea (78),  Renal Failure Acute (71),  Vomiting (62),  Pyrexia (61),  Oedema Peripheral (61),  Erythema (60),  Diarrhoea (55),  Nausea (52),  Pruritus (51), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Clarithromycin review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		lower respiratory tract infection
Dosage & duration:		500 mg taken once daily for the period of 5 days
Other conditions:		coughing
Other drugs taken:		none
		Reported Results
Benefits:		It clears the infection in the sinus and lower respiratory tract. I was coughing badly due to irritation from mucus formed by post nasal drip down the throat. The phlegm was yellow in colour.
Side effects:		I have not experienced any side effects like bloating, nausea or anything like that.
Comments:		Dosage 500 mg once daily for 5 days on full stomach.

Clarithromycin review by 21 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Sinusitis
Dosage & duration:		500mg taken every 12 hours for the period of 7 days
Other conditions:		IBS
Other drugs taken:		Birth control, Mebeverine
		Reported Results
Benefits:		Started to work within 12 hours, much less pus and blood from nostrils. Pressure in face reduced with in 36 hours.
Side effects:		Severe nausea, bitter taste in mouth within an hour of first dose. IBS flare up within a few hours of taking the dose, abdominal pain and achy joints and neck.
Comments:		Sinusitis diagnosed after 1 week of pressure headache and pussy nosebleeds. 1000mg per day for 7 days prescribed. Aggrivated IBS and caused severe nausea and bitterness in the mouth that disturbed sleep pattern. Also feeling of anxiety noted.

Clarithromycin review by 15 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Strep Throat
Dosage & duration:		500mg taken once per day for the period of once
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Immediately took the pain from the Strep away.
Side effects:		Terrible taste in mouth, 4 and a half hours of constant dry-heaving, painful and sudden headaches, body aches.
Comments:		The side effects were so terrible, never felt so badly in my entire life. WOuldnt recommend for anyone unless they have a strong stomach