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:

Marlex Pharmaceuticals Inc

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 for oral solution, USP (pediatric) is indicated in the treatment of serious infections cause 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 WARNING box, 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 fema

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 100mL of solution containing 75mg of clindamycin per 5mL (NDC 10135-569-19). Storage Conditions:   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN PALMITATE HYDROCHLORIDE- CLINDAMYCIN PALMITATE
HYDROCHLORIDE SOLUTION
MARLEX PHARMACEUTICALS INC
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CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE- CLINDAMYCIN PALMITATE
HYDROCHLORIDE POWDER, FOR SOLUTION
MARLEX PHARMACEUTICALS INC. OF NEW CASTLE, DELAWARE
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CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP (PEDIATRIC)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
palmitate hydrochloride (HCl) for oral solution, USP (pediatric) and
other antibacterial drugs,
clindamycin palmitate HCl for oral solution, USP (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