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

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Rising Pharma Holdings, Inc.

INN (International namn):

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Sammansättning:

CLINDAMYCIN 75 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) flavored granules is available in bottles of 100 mL (NDC 64980-511-10). When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Rx only

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- CLINDAMYCIN
PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION
RISING PHARMA HOLDINGS, INC.
----------
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP
(PEDIATRIC)
NDC 64980-511-10
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 sho