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:

NuCare Pharmaceuticals,Inc.

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 endome

Product summary:

Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted DAN 5708 supplied in bottles of 100. NDC 68071-3207-1 Bottles of 100 Dispense in a tight container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
REVISED: MAY 2016
RX ONLY
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.
WARNING
_CLOSTRIDIUM DIFFICILE_ ASSOCIATED DIARRHEA (CDAD) HAS BEEN REPORTED
WITH USE OF NEARLY ALL
ANTIBACTERIAL AGENTS, INCLUDING CLINDAMYCIN HYDROCHLORIDE 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 HYDROCHLORIDE 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. Cl