CLINDAMYCIN- clindamycin phosphate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN PHOSPHATE 150 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP 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 Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the

Product summary:

Clindamycin Injection, USP, in the Pharmacy Bulk Package, supplied as clindamycin phosphate equivalent to clindamycin 150 mg/mL, is available as: Packaged individually. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not refrigerate. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLINDAMYCIN - CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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CLINDAMYCIN INJECTION USP
Rx only PHARMACY BULK PACKAGE
– NOT FOR DIRECT INFUSION
FOR INTRAVENOUS USE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Clindamycin
Injection, USP and other antibacterial drugs, Clindamycin Injection,
USP 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 Injection, USP 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 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 Injection, USP for intravenous use contains clin