CLARITHROMYCIN tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Rebel Distributors Corp.

INN (Medzinárodný Name):

clarithromycin

Zloženie:

clarithromycin 250 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions as listed below: 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,

Prehľad produktov:

Clarithromycin tablets 250 mg are white, oval-shaped, film-coated tablets, debossed GG C6 on one side and plain on the reverse side, and are supplied as follows: NDC 21695-557-10 in bottles of 10 tablets Clarithromycin tablets 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows: NDC 21695-558-10 in bottles of 10 tablets NDC 21695-558-14 in bottles of 14 tablets NDC 21695-558-20 in bottles of 20 tablets NDC 21695-558-28 in bottles of 28 tablets Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight container as described in the USP. Protect from light.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CLARITHROMYCIN- CLARITHROMYCIN TABLET
REBEL DISTRIBUTORS CORP.
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CLARITHROMYCIN TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin
and other antibacterial drugs, clarithromycin tablets 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 747.96. 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 clarithromycin tablet intended for oral administration contains
250 mg or 500 mg of
clarithromycin. In addition, each clarithromycin tablet contains the
following inactive ingredients:
croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 80, povidone, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
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.
38
69
13
In nonfasting healthy human subjects (male