CLINDAMYCIN HYDROCHLORIDE capsule

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)

Disponible depuis:

RedPharm Drug, Inc.

DCI (Dénomination commune internationale):

CLINDAMYCIN HYDROCHLORIDE

Composition:

CLINDAMYCIN 150 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are 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). 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

Descriptif du produit:

Clindamycin Hydrochloride Capsules USP, 150 mg are light blue opaque/light green transparent size ‘1’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘39’ on light green transparent body with black ink. Bottles of 100 NDC 65862-185-01 Bottles of 500 NDC 65862-185-05 Clindamycin Hydrochloride Capsules USP, 300 mg are light blue opaque/light blue opaque size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘40’ on light blue opaque body with black ink. Bottles of 16 NDC 65862-186-16 Bottles of 100 NDC 65862-186-01 Bottles of 500 NDC 65862-186-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight container with child-resistant closure.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
----------
BOXED 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. 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.
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 produce