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:

RedPharm Drug, Inc.

INN (International Name):

CLINDAMYCIN HYDROCHLORIDE

Composition:

CLINDAMYCIN 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 female pelvis and genital tract such as endometri

Product summary:

Clindamycin hydrochloride capsules, USP (equivalent to 150 mg of clindamycin) are opaque gray and opaque pink capsules imprinted “DAN 5708” supplied in bottles of 100. Clindamycin hydrochloride capsules, USP (equivalent to 300 mg of clindamycin) are opaque pink capsules imprinted “DAN 3120” supplied in bottles of 16 and 100. Dispense in a tight container with a child-resistant closure. 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 HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
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WARNING
WARNING
Clostridium difficile associated diarrhea (CDAD) has been reported
with use of nearly all
antibacterial agents, including clindamycin hydrochloride 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 hydrochloride 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.
difficileproduces 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 electrolytemanagement,
protein supplementation,
antibiotic treatment of C. difficile, and surgical evaluation should
be instituted as clinically
indicated
SPL UNCLASSIFIED SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin
hydrochloride and other antibacterial drugs, clindamycin hydrochloride
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 produced by a 7(