CLINDAMYCIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba Sky Packaging

INN (International Name):

CLINDAMYCIN HYDROCHLORIDE

Composition:

CLINDAMYCIN 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is 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 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 gastrointestinal tract); infections of the female pelvis and genital tract such as

Product summary:

Product: 63739-059 NDC: 63739-059-10 100 CAPSULE in a BLISTER PACK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
MCKESSON CORPORATION DBA SKY PACKAGING
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CLINDAMYCIN
HYDROCHLORIDE
CAPSULES USP
RX only
Revised: March 2009
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin HCl
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.
WARNING
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
semisyn