Clarithromycin

Clarithromycin is an oral macrolide antibiotic similar to erythromycin and azithromycin. Like azithromycin, clarithromycin penetrates lung tissue and macrophages to a greater degree than does erythromycin. This may partially explain why clarithromycin is effective against Mycobacterium avium complex (MAC). Clarithromycin is commonly used in infections of the respiratory tract, sexually transmitted infections, otitis media, and infections in AIDS patients. Clarithromycin also has been used to treat gastrointestinal Helicobacter pylori infection.

Clarithromycin’s innovator is Abbott-Global and is known world-wide under the brand names: Biaxin and Klaricid.

Like other macrolides, clarithromycin binds to the 50 S subunit of the 70 S ribosome, thereby blocking RNA-mediated bacterial protein synthesis. Clarithromycin can be bacteriostatic or bactericidal in action, depending on the concentration as well as the particular organism and its inoculum. In addition, it appears that an alkaline pH facilitates bacterial cell penetration, since clarithromycin exists in a unionized state in this environment. Clarithromycin also penetrates phagocytes and macrophages efficiently, and, as a result, it is effective against a wide variety of organisms in respiratory infections.

Clarithromycin is generally active against organisms that are usually susceptible to erythromycin. These include most staphylococcal and streptococcal strains. In addition, clarithromycin is active against Moraxella catarrhalis, Mycoplasma pneumoniae, Legionella species, and Chlamydia pneumoniae. Clarithromycin inhibits Mycobacterium avium at concentrations achievable in lung tissue and is active against Borrelia burgdorferi, the cause of Lyme disease.

In addition, Clarithromycin is metabolized to 14-OH clarithromycin, which has substantial antimicrobial activity.
Clarithromycin inhibits the hepatic microsomal CYP3A4 isoenzyme. Clarithromycin also acts as an inhibitor of P-glycoprotein, an energy-dependent drug efflux pump.

Clarithromycin appears in the following formulation and dosages:
Oral Powder for Suspension: 125 MG/5 ML, 250 MG/5 ML
Oral Tablet: 250 MG, 500 MG
Oral Tablet, Extended Release: 500 MG

General data on Clarithromycin Active Pharmaceutical Ingredient

CAS Registry: 81103-11-9
ATC: J01FA09
Molecular Formula: C38H69NO13
Molecular Weight: 748.0
Pharmacopoeias: In Chin., Eur., Jpn, and US.

TAPI's Clarithromycin Pharmaceutical Ingredient

TAPI's Clarithromycin Active Pharmaceutical Ingredient is produced in Assia Chemical Industries Limited - Teva Tech site in Beer Sheva, Israel.

Clarithromycin is produced by TAPI by Semi-Synthetic - Antibiotic synthesis and considered to be high volume Active Pharmaceutical Ingredient.

Pharmacopoeias

Ph. Eur. 5.5: Clarithromycin is a white or almost white, crystalline powder. Clarithromycin is practically insoluble in water; soluble in acetone and in dichloromethane; slightly soluble in methyl alcohol.

USP 29: Clarithromycin is a white to off-white crystalline powder. Clarithromycin  is practically insoluble in water; slightly soluble in dehydrated alcohol, in methyl alcohol, and in acetonitrile; soluble in acetone; slightly soluble in phosphate buffer at pH values of 2 to 5. pH of a 0.2% suspension in a mixture of water and methyl alcohol (19:1) is between 8.0 and 10.0.

2008 Available DMF: U.S. DMF, EU CTD, CEP, LATAM DMF, India DMF, Japan DMF and Korea DMF.

TAPI provide full service on this product and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Clarithromycin. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Clarithromycin.

Another product, in the group of ANTIBACTERIALS - Macrolides, available on TAPI's portfolio is: Azithromycin. Contact us today for information on these products.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients