CLINDAMYCIN HYDROCHLORIDE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

St. Mary's Medical Park Pharmacy

Designación común internacional (DCI):

CLINDAMYCIN HYDROCHLORIDE

Composición:

CLINDAMYCIN 300 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 p

Resumen del producto:

Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in: NDC: 60760-0693-16 bottle of 16 60760-0693-20 bottle of 20 60760-0693-30 bottle of 30 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].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
ST. MARY'S MEDICAL PARK PHARMACY
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CLINDAMYCIN HCL CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
hydrochloride 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 HCl 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 HCl 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
semisynthetic