CLINDAMYCIN PALMITATE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone 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 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). 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 endometri

Product summary:

Clindamycin palmitate HCl pediatric flavored granules for oral solution is available in bottles of 100 mL (NDC 59762-0016-1). When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PALMITATE HYDROCHLORIDE- CLINDAMYCIN PALMITATE
HYDROCHLORIDE SOLUTION
GREENSTONE LLC
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CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP
FOR PEDIATRIC USE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin palmitate HCl and other antibacterial drugs, clindamycin
palmitate HCl 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.
DESCRIPTION
Clindamycin palmitate hydrochloride is a water soluble hydrochloride
sal