CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- clindamycin palmitate hydrochloride granule, for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Lyne Laboratories, Inc.

Designació comuna internacional (DCI):

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Composición:

CLINDAMYCIN 75 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) (clindamycin palmitate 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 gastroi

Resumen del producto:

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) flavored granules is available in bottles of 100 mL (NDC 0374-5070-01). When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Rx only

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- CLINDAMYCIN PALMITATE
HYDROCHLORIDE GRANULE, FOR SOLUTION
LYNE LABORATORIES, INC.
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CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP
(PEDIATRIC)
NDC 0374-5070-01
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
palmitate hydrochloride for oral solution (Pediatric) and other
antibacterial drugs, clindamycin palmitate
hydrochloride for oral solution (Pediatric) 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 b