CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- clindamycin palmitate hydrochloride solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CLINDAMYCIN PALMITATE HYDROCHLORIDE (UNII: VN9A8JM7M7) (CLINDAMYCIN - UNII:3U02EL437C)

Disponible desde:

InvaGen Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clindamycin palmitate hydrochloride for oral solution  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 palmitate hydrochloride for oral solution, USP is available in bottles of 100 mL (NDC 67787-515-71). When reconstituted as directed, each bottle yields 100 mL of solution containing 75 mg of clindamycin per 5 mL. Rx only

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- CLINDAMYCIN PALMITATE
HYDROCHLORIDE SOLUTION
INVAGEN PHARMACEUTICALS, INC.
----------
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION AND OTHER
ANTIBACTERIAL DRUGS, CLINDAMYCIN
PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION SHOULD BE USED ONLY TO TREAT
OR PREVENT INFECTIONS THAT
ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
_NOT FOR INJECTION_
.
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
Cli