CLINDAMYCIN HYDROCHLORIDE- clindamycin hydrochloride capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Preferred Pharmaceuticals Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 hydrochloride capsules, USP, 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 gastr

Tóm tắt sản phẩm:

Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: 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: NDC 68788-7308-1 Bottles of 14 NDC 68788-7308-2 Bottles of 20 NDC 68788-7308-8 Bottles of 21 NDC 68788-7308-3 Bottles of 30 NDC 68788-7308-4 Bottles of 40 NDC 68788-7308-5 Bottles of 56 NDC 68788-7308-6 Bottles of 60 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
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 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.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin.