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:

American Health Packaging

INN (International Name):

CLINDAMYCIN HYDROCHLORIDE

Composition:

CLINDAMYCIN 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tract); infec

Product summary:

Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: Clindamycin hydrochloride capsules, USP, 150 mg are size ‘1’ capsules with turquoise blue opaque cap and light green body imprinted with “RX692” on cap and body in black ink containing white to off white powder. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-243-01 Clindamycin hydrochloride capsules, USP, 300 mg are size ‘0’ capsules with turquoise blue opaque cap and turquoise blue opaque body imprinted with “RX693” on cap and body in black ink containing white to off white powder. They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-244-01 Store at 20° – 25° C (68° – 77° F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
AMERICAN HEALTH PACKAGING
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CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
8224301/0123
RX ONLY
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.
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
USAGEsection. 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.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
cli