CLINDAMYCIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clindamycin hydrochloride (UNII: T20OQ1YN1W) (clindamycin - UNII:3U02EL437C)

Available from:

Rebel Distributors Corp

INN (International Name):

clindamycin hydrochloride

Composition:

clindamycin hydrochloride 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules 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. Clindamycin 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 describe

Product summary:

Clindamycin hydrochloride capsules are available in the following strengths, colors and sizes: 150 mg Turquoise blue opaque cap and light green body printed with “RX692” on cap and body in black ink. NDC 21695-033-12 Bottles of 12 NDC 21695-033-21 Bottles of 21 NDC 21695-033-28 Bottles of 28 NDC 21695-033-40 Bottles of 40 NDC 21695-033-60 Bottles of 60 NDC 21695-033-90 Bottles of 90 300 mg Turquoise blue opaque cap and turquoise blue opaque body printed with “RX693” on cap and body in black ink. NDC 21695-034-21 Bottles of 21 NDC 21695-034-30 Bottles of 30 Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
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CLINDAMYCIN HYDROCHLORIDE CAPSULES
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.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
hydrochloride capsules and other antibacterial drugs, clindamycin
hydrochloride capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Clindamycin is a
semisynthetic antibiotic produ