CLINDAMYCIN HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)

可用日期:

DIRECT RX

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastro

授权状态:

Abbreviated New Drug Application

产品特点

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
DIRECT RX
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CLINDAMYCIN HYDROCHLORIDE 150MG
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Clindamycin is a
semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the
7(R)-hydroxyl group of the parent
compound lincomycin.
Clindamycin hydrochloride capsules, USP contain clindamycin
hydrochloride, USP equivalent to 150
mg or 300 mg of clindamycin.
Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C
Yellow #10, FD&C Blue no. 1,
gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide,
propylene glycol, shellac, talc,
and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C
Blue no. 1, gelatin, lactose
monohydrate, magnesium stearate, potassium hydroxide, propylene
glycol, shellac, talc, and titanium
dioxide.
The structural formula is represented below:
structure
C18H33ClN2O5S•HCl M.W. 461.45
The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,
7, 8-trideoxy-6-(1-methyl-
trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside
monohydrochloride.
CLINICAL PHARMACOLOGY
Human Pharmacology
Absorption
Serum level studies with a 150 mg oral dose of clindamycin
hydrochloride in 24 normal adult
volunteers showed that clindamycin was rapidly absorbed after oral
administration. An average peak
serum level of 2.50 mcg/mL was reached in 45 minutes; serum levels
averaged 1.51 mcg/mL at 3 hours
and 0.70 mcg/mL at 6 hours. Absorption of an oral dose is virtually
complete (90%), and the
concomitant administration of food does not appreciably modify the
serum concentrations; serum levels
have been uniform and predictable from person to person and dose to
dose. Serum level studies
following multiple doses of clindamycin hydrochloride for up to 14
days show no evidence of
accumulation or altered metabolism of drug. Doses of up to 2 grams of
clindamycin per day for 14 days
have been well tolerated by healthy volunteers, except that