Biaxin (Clarithromycin) - Summary

BIAXIN SUMMARY

Clarithromycin is a semi-synthetic macrolide antibiotic.

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.

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

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.

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.

See all Biaxin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Biaxin (Clarithromycin)

Expression comparison of azithromycin and clarithromycin in triple-therapy regimens for eradication of Helicobacter pylori in hemodialysis patients. [2014]
To compare a triple-therapy regimen based on change of antibiotic (azithromycin and clarithromycin) for the eradication of Helicobacter pylori in hemodialysis (HD) patients, we studied in a prospective, randomized, double-blinded clinical trial 39 patients who had dyspepsia and showed two positive results from the diagnostic tests of H...

Evaluation of subgingivally delivered 0.5% clarithromycin as an adjunct to nonsurgical mechanotherapy in the management of chronic periodontitis: a short-term double blinded randomized control trial. [2014]
periodontitis subjects... CONCLUSION: Adjunctive use of 0.5% CLM as a controlled drug delivery system

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.

more studies >>

Clinical Trials Related to Biaxin (Clarithromycin)

Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma [Completed]
The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells. There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.

Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects [Active, not recruiting]

Clarithromycin for the Treatment of Hypersomnia [Completed]
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a problem with the quality of sleep occurring at night, for instance when nighttime sleep is disrupted by frequent breathing pauses. In other cases, however, hypersomnia occurs even when nighttime sleep is of good quality. These cases of hypersomnia are presumed to be a symptom of brain dysfunction, and so are referred to as hypersomnias of central (i. e., brain) origin. The causes of most of these central hypersomnias are not known. However, our group has recently identified a problem with the major brain chemical responsible for sedation, known as GABA. In a subset of our hypersomnia patients, there is a naturally-occurring substance that causes the GABA receptor to be hyperactive. In essence, it is as though these patients are chronically medicated with Valium (or Xanax or alcohol, all substances that act through the GABA system), even though they do not take these medications. Current treatment of central hypersomnias is limited. For the fraction of cases with narcolepsy, there are FDA-approved, available treatments. However, for the remainder of patients, there are no treatments approved by the FDA. They are usually treated with medications approved for narcolepsy, but sleep experts agree that these medications are often not effective for this group of patients. Based on our understanding of the GABA abnormality in these patients, we evaluated whether clarithromycin (an antibiotic approved by the FDA for the treatment of infections) would reverse the GABA abnormality. In a test tube model of this disease, clarithromycin does in fact return the function of the GABA system to normal. The investigators have treated a few patients with clarithromycin and most have felt that their hypersomnia symptoms improved with this treatment. To determine whether clarithromycin is truly beneficial for central hypersomnia, this study will compare clarithromycin to an inactive pill (the placebo). All subjects will receive both clarithromycin and the placebo at different times, and their reaction times and symptoms will be compared on these two treatments to determine if one is superior. If this study shows that clarithromycin is more effective than placebo in the treatment of hypersomnia, it will identify a potential new therapy for this difficult-to-treat disorder.

Clarithromycin as Immunomodulator for the Management of Sepsis [Completed]
The herein protocol is based on the results of one former clinical trial conducted by our study group showing the considerable efficacy of intravenously administered clarithromycin as an adjuvant to antimicrobial chemotherapy for patients with sepsis, septic shock and respiratory failure in the field of ventilator-associated pneumonia. The proposed clinical trial is based on the need to generalize the application of intravenous clarithromycin in the total of admitted septic patients irrespective of the underlying cause of sepsis.

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

more trials >>

Reports of Suspected Biaxin (Clarithromycin) Side Effects

Drug Hypersensitivity (16),  Drug Interaction (12),  Nausea (12),  Rash (11),  Malaise (10),  Drug Ineffective (9),  Urticaria (9),  Paraesthesia (8),  Arthralgia (8),  Thrombosis (7), more >>

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 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Strep throat
Dosage & duration:		500 mg tablets taken twice a day for the period of 10 days
Other conditions:		none
Other drugs taken:		Advil
		Reported Results
Benefits:		It worked quickly--within two days my sore throat began to feel better and the night sweats disappeared.
Side effects:		Dry mouth, yeast infection
Comments:		The drug did not fully get rid of strep throat. After the 10 day supply was exhausted, strep throat reappeared and was treated successfully with levaquin for 14 days.

Biaxin review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		Inner Ear Infection
Dosage & duration:		500 mg taken twice a day for the period of 7 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		There weren't any. I had to stop taking this medicine after 4 days due to the side effects.
Side effects:		Severe stomach cramping along with frequent visits to the bathroom. I have had this experience with every type of this medicine: Z-Pack (zithromycin), arithromycin, and now the clarithroymcin. My doctor said the side effects with the clarithromycin are much less compared to the other types and I found this to be false. With all the above mentioned medicines, I've always started to get stomach problems on the fourth day.
Comments:		I stopped taking the medicine after side effects appeared.