CLINDAMYCIN HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CLINDAMYCIN HYDROCHLORIDE

Sammensetning:

CLINDAMYCIN 300 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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  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

Produkt oppsummering:

Clindamycin Hydrochloride Capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted “DAN 3120” supplied in bottles of Bottles of 4 (NDC 55289-890-04). Bottles of 9 (NDC 55289-890-09). Bottles of 15 (NDC 55289-890-15). Bottles of 20 (NDC 55289-890-20). Bottles of 21 (NDC 55289-890-21). Bottles of 28 (NDC 55289-890-28). Bottles of 30 (NDC 55289-890-30). Bottles of 40 (NDC 55289-890-40). Bottles of 56 (NDC 55289-890-56). 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]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Rx only

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
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, USP is the hydrated hydrochloride salt of
clindamycin.
Clindamycin is a semisy