CLINDAMYCIN HYDROCHLORIDE capsule

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

REMEDYREPACK INC.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules 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); infections of the female pelvis and geni­tal tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; seri­ous skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to deter­mine the causative organisms and their susceptibility to clindamycin. 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 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 hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

পণ্য সারাংশ:

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. NDC: 70518-2735-00 NDC: 70518-2735-01 NDC: 70518-2735-02 NDC: 70518-2735-03 NDC: 70518-2735-04 NDC: 70518-2735-05 NDC: 70518-2735-06 NDC: 70518-2735-07 PACKAGING: 20 in 1 BLISTER PACK PACKAGING: 16 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 21 in 1 BOTTLE PLASTIC PACKAGING: 28 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP
RX ONLY
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.
WARNING
_Clostridioides 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. Clindamycin
is a semisynt