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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

CLINDAMYCIN PALMITATE HYDROCHLORIDE

Composition:

CLINDAMYCIN 75 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Product summary:

Clindamycin palmitate HCl for oral solution, USP (pediatric) is a white to off-white powder forming a clear colorless cherry flavored solution upon constitution with water. When reconstituted as directed, each bottle yields 100 mL of solution containing 75 mg of clindamycin per 5 mL (NDC 65162-468-19). Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)- CLINDAMYCIN
PALMITATE HYDROCHLORIDE POWDER, FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
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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
_Clostridioides 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.
DES