CLINDAMYCIN HYDROCHLORIDE- 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:

Cosette Pharmaceuticals, Inc.

INN (International Name):

CLINDAMYCIN HYDROCHLORIDE

Composition:

CLINDAMYCIN 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin HCl 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 BOXED WARNING , 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 trac

Product summary:

Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 150 mg and 300 mg of clindamycin and are available as: 150 mg: red opaque colored cap, imprinted with “G&W” and blue opaque colored body, imprinted “3171” in bottles of 100 (NDC 0713-3171-01). 300 mg: light blue opaque colored cap imprinted with “G&W” and light blue opaque colored body, imprinted “5256” in bottles of 100 (NDC 0713-5256-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN HYDROCHLORIDE - CLINDAMYCIN HYDROCHLORIDE CAPSULE
COSETTE PHARMACEUTICALS, INC.
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CLINDAMYCIN HYDROCHLORIDE CAPSULES USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
hydrochloride capsules, USP and other antibacterial drugs, clindamycin
hydrochloride capsules, USP
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
WARNING
_Clostridium difficile_ associated diarrhea (CDAD) has been reported
with use of nearly all
antibacterial agents, including clindamycin and may range in severity
from mild diarrhea to fatal
colitis. Treatment with antibacterial agents alters the normal flora
of the colon, leading to
overgrowth of _C. difficile_.
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.
_C. difficile _produces toxins A and B, which contribute to the
development of CDAD. Hypertoxin
producing strains of _C. difficile _cause increased morbidity and
mortality, as these infections can be
refractory to antimicrobial therapy and may require colectomy. CDAD
must be considered in all
patients who present with diarrhea following antibiotic use. Careful
medical history is necessary
since CDAD has been reported to occur over two months after the
administration of antibacterial
agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against _C. difficile _may
need to be discontinued. Appropriate fluid and electrolyte management,
protein supplementation,
antibiotic treatment of _C. difficile_, and surgical evaluation should
be instituted as clinically
indicated.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Clindamycin is a
s