CLARITHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clarithromycin (UNII: H1250JIK0A) (clarithromycin - UNII:H1250JIK0A)

Available from:

Allied Pharma Inc

INN (International Name):

clarithromycin

Composition:

clarithromycin 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below: Adults 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 , Mycop

Product summary:

Clarithromycin Tablets, USP 500 mg are white to off-white, film- coated, oval-shaped tablets, debossed with "NT" on one side and "061" on the other side of the tablet, bottles of 60 NDC 76267-061-02 Clarithromycin Tablets, USP 250 mg are white to off-white, film- coated, oval-shaped tablets, debossed with "NT" on one side and "060" on the other side of the tablet, bottles of 60 NDC 76267-060-02 Store in a well closed container at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.   Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closures (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN - CLARITHROMYCIN TABLET, FILM COATED
ALLIED PHARMA INC
---------- CLARITHROMYCIN TABLETS, USP R ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CLARITHROMYCIN AND OTHER ANTIBACTERIAL DRUGS, CLARITHROMYCIN SHOULD BE
USED ONLY TO TREAT OR
PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED
BY BACTERIA.
DESCRIPTION
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically,
it is 6-_0_-methylerythromycin.
The molecular formula is C
H NO , and the molecular weight is 747.95. The structural formula is:
Clarithromycin is a white to off-white crystalline powder. It is
soluble in acetone, slightly soluble in
methanol, ethanol, and acetonitrile, and practically insoluble in
water.
Each white to off-white, film-coated, oval shaped immediate-release
clarithromycin tablets, USP
contains 250 mg or 500 mg of clarithromycin and the following inactive
ingredients:
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
povidone, pregelatinized
starch, colloidal silicon dioxide, talc, titanium dioxide, polyvinyl
alcohol and polyethylene glycol.
CLINICAL PHARMACOLOGY
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PHARMACOKINETICS
Clarithromycin is rapidly absorbed from the gastrointestinal tract
after oral administration. The absolute
bioavailability of 250 mg clarithromycin tablets was approximately
50%. For a single 500 mg dose of
clarithromycin, food slightly delays the onset of clarithromycin
absorption, increasing the peak time
from approximately 2 to 2.5 hours. Food also increases the
clarithromycin peak plasma concentration by
about 24%, but does not affect the extent of clarithromycin
bioavailability. Food does not affect the
onset of formation of the antimicrobially active metabolite, 14-OH
clarithromycin or its peak plasma
concentration but does slightly decrease the extent of metabolite
formation, indicated by an 11%
decrease in area under the plasma concentration-time curve (AUC).
Therefore, clarithromycin tablets
may be given without regard to food.
In n