Biaxin

Biaxin Information

Brand Name: Biaxin

Generic Name: Clarithromycin

Other Common Names: Klaracid, Biaxin XL

Biaxin (clarithromycin) is an antibiotic used to treat infections such as sinus infections, throat infections, tonsil infections and other lung related infections. Biaxin (clarithromycin) can be used by some patients to prevent infections.

Biaxin Indications

Biaxin (clarithromycin) and granules for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Adult Biaxin Indications

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. Biaxin (clarithromycin) is generally effective in the eradication of S. pyrogenes from the nasopharynx; however, data establishing the efficacy of Biaxin (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, Moraxella catarrhalis, or Streptococcus pneumoniae.

Pneumonia due to 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 lansoprazole (Prevacid) or omeprazole (Prilosec) 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 (clarithromycin) Filmtab tablets in combination with omeprazole (Prilosec) capsules or ranitidine bismuth citrate (Tritec) tablets are also indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. However, regimens which contain Biaxin (clarithromycin) as the single antimicrobial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. Biaxin (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 Biaxin (clarithromycin) therapy, susceptibility testing should be done if possible. If resistance to Biaxin (clarithromycin) is demonstrated, a non-clarithromycin-containing therapy is recommended.

Children Biaxin Indications

Pharyngitis/Tonsillitis due to Streptococcus pyogenes.

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.

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.

Prophylaxis Biaxin Indications

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

Biaxin Ingredients and Composition

How Does Biaxin Work?

Biaxin (clarithromycin) exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis.

Biaxin (clarithromycin) is active in vitro against a variety of aerobic and anaerobic gram-positive and gram-negative microorganisms as well as most Mycobacterium avium complex (MAC) microorganisms.

Additionally, the 14-OH clarithromycin (Biaxin) metabolite also has clinically significant antimicrobial activity. The 14-OH clarithromycin (Biaxin ) is twice as active against Haemophilus influenzae microorganisms as the parent compound. However, for Mycobacterium avium complex (MAC) isolates the 14-OH metabolite is 4 to 7 times less active than Biaxin (clarithromycin). The clinical significance of this activity against Mycobacterium avium complex is unknown.

Biaxin (clarithromycin) has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in DOSAGE.

Aerobic Gram-positive Microorganisms Sensitive to Biaxin (clarithromycin): Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyrogenes.

Aerobic Gram-negative Microorganisms Sensitive to Biaxin (clarithromycin): Haemophilus influenzae, Moraxella catarrhalis.

Other Microorganisms Sensitive to Biaxin (clarithromycin): Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR).

Mycobacteria Sensitive to Biaxin (clarithromycin): Mycobacterium avium complex (MAC) consisting of: Mycobacterium avium, Mycobacterium intracellulare.

Beta-lactamase production should have no effect on Biaxin (clarithromycin)activity.

How To Take Biaxin and Biaxin Dosage and Administration

Biaxin dosage according to condition:

Pharyngitis/Tonsillitis 250 mg, 10 days
Acute maxillary sinusitis 500 mg, 14 days

Acute exacerbation of chronic bronchitis due to:

S. pneumoniae 250 mg, 7 to 14 days
M. catarrhalis 250 mg, 7 to 14 days
H. influenzae 500 mg, 7 to 14 says

Pneumonia due to:

S. pneumoniae 250 mg, 7 to 14 days
M. pneumoniae 250 mg, 7 to 14 days

Uncomplicated skin and skin structure 250 mg 7 to 14

Biaxin (clarithromycin) tablets and clarithromycin for oral suspension may be given with or without food.

Biaxin Side Effects

Biaxin Warnings

Biaxin Precautions and Contraindications

General

Biaxin (clarithromycin) is principally excreted via the liver and kidney. Biaxin (clarithromycin) may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged Biaxin dosing intervals may be appropriate.

Biaxin (clarithromycin) in combination with ranitidine bismuth citrate therapy is not recommended in patients with creatinine clearance less than 25 ml/min.

Biaxin (clarithromycin) in combination with ranitidine bismuth citrate should not be used in patients with a history of acute porphyria.

Taking Biaxin during Pregnancy or Breast-feeding

It is not known whether Biaxin (clarithromycin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Biaxin (clarithromycin) is administered to a nursing woman. It is known that Biaxin (clarithromycin) is excreted in the milk of lactating animals and that other drugs of this class are excreted in human milk. Preweaned rats, exposed indirectly via consumption of milk from dams treated with 150 mg/kg/day for 3 weeks, were not adversely affected, despite data indicating higher drug levels in milk than in plasma.

Contraindications to Biaxin

Biaxin (clarithromycin) is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics.

Concomitant administration of Biaxin (clarithromycin) with cisapride, pimozide, or terfenadine is contraindicated. There have been post-marketing reports of drug interactions when Biaxin (clarithromycin) and/or erythromycin are co-administered with cisapride, pimozide, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of hepatic metabolism of these drugs by erythromycin and Biaxin (clarithromycin). Fatalities related to such Biaxin (clarithromycin) coadministration have been reported.

Biaxin Clinical Trials and Studies

Storing Biaxin

Store Biaxin tablets and granules for oral suspension at controlled room temperature 15-30° C (59-86° F) in a well-closed container. Protect Biaxin from light. Do not refrigerate Biaxin suspension.

Information about the Manufacturer of Biaxin

Biaxin is manufactured by: Abbott.