CLINDAMYCIN- clindamycin phosphate injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
08-12-2022

Viambatanisho vya kazi:

Clindamycin Phosphate (UNII: EH6D7113I8) (Clindamycin - UNII:3U02EL437C)

Inapatikana kutoka:

Akorn

INN (Jina la Kimataifa):

Clindamycin Phosphate

Tungo:

Clindamycin 300 mg in 50 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% dextrose injection 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 antibiotic-associated pseudomembranous 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). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. Clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused b

Bidhaa muhtasari:

Clindamycin in 5% dextrose injection is a sterile solution of clindamycin phosphate with 5% dextrose. It is available in 50 mL clear molded glass bottles fitted with an injection stopper. Bottles are intended for single use only and are available as follows: Exposure of pharmaceutical products to heat should be minimized. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                CLINDAMYCIN- CLINDAMYCIN PHOSPHATE INJECTION
AKORN
----------
CLINDAMYCIN IN 5% DEXTROSE INJECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin in 5% dextrose injection and other antibacterial drugs,
clindamycin in 5%
dextrose injection should be used only to treat or prevent infections
that are proven or
strongly suspected to be caused by bacteria.
FOR INTRAVENOUS USE ONLY
WARNING
_Clostridium difficile-_associated diarrhea (CDAD) has been reported
with use of
nearly all antibacterial agents, including clindamycin in 5% dextrose
injection 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 in 5% dextrose injection 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 in 5% dextrose injection in bottles contains clindamycin
phosphat
                                
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