Biaxin (Clarithromycin) - Summary

BIAXIN SUMMARY

BIAXIN® Filmtab®
(clarithromycin tablets, USP)
BIAXIN® XL Filmtab®
(clarithromycin extended-release tablets)
BIAXIN® Granules
(clarithromycin for oral suspension, USP)

Clarithromycin is a semi-synthetic macrolide antibiotic.

BIAXIN Filmtab (clarithromycin tablets, USP) and BIAXIN Granules (clarithromycin for oral suspension, USP) are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below:

Adults (BIAXIN Filmtab Tablets and Granules for Oral Suspension)

Pharyngitis/Tonsillitis due to Streptococcus pyogenes (The usual drug of choice in the treatment and prevention of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route. Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present).

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, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR).

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage).

Disseminated mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare

BIAXIN (clarithromycin) Filmtab tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) Delayed-Release Capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.

BIAXIN Filmtab tablets in combination with PRILOSEC (omeprazole) capsules or TRITEC (ranitidine bismuth citrate) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain clarithromycin as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting.

In patients who fail therapy, susceptibility testing should be done if possible. If resistance to clarithromycin is demonstrated, a non-clarithromycin-containing therapy is recommended. (For information on development of resistance see Microbiology section.) The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.

Children (BIAXIN Filmtab Tablets and Granules for Oral Suspension)

Pharyngitis/Tonsillitis due to Streptococcus pyogenes.

Community-Acquired Pneumonia due to Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae (TWAR)

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

Acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis , or Streptococcus pneumoniae

NOTE: For information on otitis media, see CLINICAL STUDIES - Otitis Media.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, or Streptococcus pyogenes (Abscesses usually require surgical drainage.)

Disseminated mycobacterial infections due to Mycobacterium avium , or Mycobacterium intracellulare

Adults (BIAXIN XL Filmtab Tablets)

BIAXIN XL Filmtab (clarithromycin extended-release tablets) 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 BIAXIN XL IN TREATING OTHER INFECTIONS FOR WHICH OTHER FORMULATIONS OF BIAXIN ARE APPROVED HAVE NOT BEEN ESTABLISHED.

Prophylaxis

BIAXIN Filmtab tablets and BIAXIN Granules for oral suspension are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BIAXIN and other antibacterial drugs, BIAXIN 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.

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BIAXIN NEWS HIGHLIGHTS

Published Studies Related to Biaxin (Clarithromycin)

Clarithromycin vs ciprofloxacin as adjuncts to rifampicin and ethambutol in treating opportunist mycobacterial lung diseases and an assessment of Mycobacterium vaccae immunotherapy. [2008.07]
BACKGROUND: The mainstays of treatment for pulmonary disease caused by opportunist mycobacteria are rifampicin (R) and ethambutol (E). The role of macrolides, quinolones and immunotherapy with Mycobacterium vaccae is not clear. A trial was undertaken to compare clarithromycin [generic for Biaxin] (Clari) and ciprofloxacin (Cipro) as third drugs added after 2 years of treatment with R and E for pulmonary disease caused by M avium-intracellulare (MAC), M malmoense and M xenopi (REClari and RECipro). An optional comparison of immunotherapy with M vaccae vs no immunotherapy was also performed... CONCLUSION: Considering all three species together, there were no differences in outcome between the REClari and RECipro groups. Immunotherapy did not improve outcome. New therapies, optimised management of co-morbid conditions and a more holistic approach must be explored in the hope of improving outcome.

Clinical trial: randomized study of clarithromycin versus placebo in active Crohn's disease. [2008.06]
BACKGROUND: Crohn's disease is characterized by defective innate immune responses to intestinal bacteria. Clarithromycin [generic for Biaxin] is a broad-spectrum antibiotic that has good penetration into macrophages. AIM: To assess the efficacy of clarithromycin in active Crohn's disease... CONCLUSION: Clarithromycin 1 g for 3 months is ineffective in active Crohn's disease but possible benefit was observed at 1 month, suggesting that an initial effect may be attenuated by subsequent bacterial resistance.

Prevalence of A2143G mutation of H. pylori-23S rRNA in Chinese subjects with and without clarithromycin use history. [2008.05.28]
CONCLUSION: Primary prevalence of the A2143G mutation was 10~14% among Chinese population without history of CLR therapy. Administration of CLR to eliminate H. pylori infection increased the prevalence of the A2143G mutation in Chinese subjects (32%) significantly.

Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease. [2008.05.02]
Objectives: We have reported increased 2.6-year mortality in clarithromycin [generic for Biaxin]- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses...

Darunavir/ritonavir pharmacokinetics following coadministration with clarithromycin in healthy volunteers. [2008.01]
This study investigated the steady-state pharmacokinetic interaction between the HIV protease inhibitor, darunavir (TMC114), administered with low-dose ritonavir (darunavir/ritonavir), and clarithromycin [generic for Biaxin] in HIV-negative healthy volunteers. In a 3-way crossover study, 18 individuals received darunavir/ritonavir 400/100 mg bid, clarithromycin 500 mg bid, and darunavir/ritonavir 400/100 mg bid plus clarithromycin 500 mg bid in 3 separate sessions for 7 days, with a washout period of at least 7 days between treatments...

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Clinical Trials Related to Biaxin (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.

Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia [Completed]

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BIAXIN PATIENT REVIEWS / RATINGS / COMMENTS

Biaxin review by 38 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		severe sinus infection
Dosage & duration:		1,000mg taken twice daily for the period of 14 days
Other conditions:		nasal cogestion
Other drugs taken:		Sudafed
		Reported Results
Benefits:		Effects on the infection were immediate; felt better in the first week of treatment.
Side effects:		Caused severe hyperpigmentation on skin unprotected with SPF.
Comments:		In 1993, after treatment of a sinus infection, had to deal with hyperpigmentation issues. So far, as of March 2008, I'm nearing my 2nd round of hydroquinone treatment to correct it.

Biaxin review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Sinus Infection
Dosage & duration:		500 mg taken twice per day for the period of 2 weeks
Other conditions:		Severe allergies, mitral valve prolapse, heartburn
Other drugs taken:		Benadryl, Claritin D, Nasocort
		Reported Results
Benefits:		Cleared up the sinus infection quickly, felt effects almost immediately (less pressure, less pain, less pus being expelled)
Side effects:		Horrible upset stomach and extremely bitter taste in the mouth.
Comments:		Took Biaxin twice per day (1,000mg total daily) and used Nasocort inhaler for inflammation of the sinuses.

Biaxin review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		ulcer
Dosage & duration:		500mg taken x2 daily for the period of 9 days
Other conditions:		none
Other drugs taken:		prevacid, amoxycillin
		Reported Results
Benefits:		I had been having abdominal pain for quites some time which was diagnosed as h-pylorybacter. I started taking the Biaxin as pary of Prevpac. In about 3 days, I noticed that the pain was lessening and I was feeling less run down. I had been ill due to the condition being undiagnosed for about 5 months. The infection was clearing up
Side effects:		After taking the Biaxin for 9 days and feeling much improvement, I started noticing some itchy bumps on my legs. Over the next 2 days, my whole body erupted into welts, especially in the axilla, the groin. I called my doctoe and stopped the Biaxin. I continued to have new hives each day for the next 5 days. Gradually they went away.
Comments:		To eliminate the side effects of hives, I had to stop the Biaxin and all other medication. I ties taking Sudaphed to control the itching, but this was not effective. I ended up going to the emergency room because the welst were so itchy and painful and I had not slept in 2 days. They were unable to give me any medication for the reaction beacuse of my gastrointestinal distress. I had to jus wait it out.