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Cleocin HCL®
(clindamycin hydrochloride capsules, USP)
See:
Cleocin T-Gel
To reduce the development of drug–resistant bacteria and maintain the
effectiveness of CLEOCIN HCl and other antibacterial drugs, CLEOCIN HCl should
be used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin.
Clindamycin is a semisynthetic antibiotic produced by a 7(S)–chloro–substitution
of the 7(R)–hydroxyl group of the parent compound lincomycin.
CLEOCIN HCl Capsules contain clindamycin hydrochloride equivalent to 75 mg, 150
mg or 300 mg of clindamycin.
Inactive ingredients: 75 mg—corn starch, FD&C blue no. 1, FD&C yellow no. 5,
gelatin, lactose, magnesium stearate and talc; 150 mg—corn starch, FD&C blue no.
1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium
dioxide; 300 mg— corn starch, FD&C blue no. 1, gelatin, lactose, magnesium
stearate, talc and titanium dioxide.
The chemical name for clindamycin hydrochloride is Methyl 7–chloro–6,7,8–trideoxy–6–(1–methyl–trans–4–propyl–L–2–pyrrolidinecarboxamido)–1–thio–L–threo–α–D–galacto–octopyranoside
monohydrochloride.
WARNING
Pseudomembranous colitis has been reported
with nearly all antibacterial agents, including clindamycin, and may range in
severity from mild to life–threatening. Therefore, it is important to consider
this diagnosis in patients who present with diarrhea subsequent to the
administration of antibacterial agents.
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. Treatment with antibacterial
agents alters the normal flora of the colon and may permit overgrowth of
clostridia. Studies indicate that a toxin produced by Clostridium difficile is
one primary cause of “antibiotic–associated colitis”.
After the diagnosis of pseudomembranous colitis has been established,
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug discontinuation alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against C. difficile colitis.
Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up
to several weeks following cessation of therapy with clindamycin.
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