CLINDAMYCIN HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

RedPharm Drug Inc.

INN (Nome Internazionale):

CLINDAMYCIN HYDROCHLORIDE

Composizione:

CLINDAMYCIN HYDROCHLORIDE 150 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Dettagli prodotto:

Clindamycin hydrochloride capsules are available in the following strengths, colors and sizes: 150 mg Turquoise blue opaque cap and light green body printed with “RX692” on cap and body in black ink. NDC 67296-0315-3 Bottles of 40 Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CLINDAMYCIN HYDROCHLORIDE - CLINDAMYCIN HYDROCHLORIDE CAPSULE
REDPHARM DRUG INC.
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WARNING
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin hydrochloride and other antibacterial drugs, clindamycin
hydrochloride should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by
bacteria.
PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH NEARLY ALL
ANTIBACTERIAL AGENTS, INCLUDING
CLINDAMYCIN, AND MAY RANGE IN SEVERITY FROM MILD TO LIFE-THREATENING.
THEREFORE, IT IS
IMPORTANT TO CONSIDER THIS DIAGNOSIS IN PATIENTS WHO PRESENT WITH
DIARRHEA SUBSEQUENT TO
THE ADMINISTRATION OF ANTIBACTERIAL AGENTS.
Because clindamycin therapy has been associated with severe colitis
which may end fatally, it
should be reserved for serious infections where less toxic
antimicrobial agents are inappropriate,
as described in the INDICATIONS AND USAGE section. It should not be
used in patients with
nonbacterial infections such as most upper respiratory tract
infections. Treatment with
antibacterial agents alters the normal flora of the colon and may
permit overgrowth of clostridia.
Studies indicate that a toxin produced by _Clostridium difficile _is
one primary cause of “antibiotic-
associated colitis”.
After the diagnosis of pseudomembranous colitis has been established,
therapeutic measures
should be initiated. Mild cases of pseudomembranous colitis usually
respond to drug
discontinuation alone. In moderate to severe cases, consideration
should be given to management
with fluids and electrolytes, protein supplementation, and treatment
with an antibacterial drug
clinically effective against _C. difficile _colitis.
Diarrhea, colitis, and pseudomembranous colitis have been observed to
begin up to several weeks
following cessation of therapy with clindamycin.
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)-hydroxy