CLEOCIN PHOSPHATE- 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:

General Injectables & Vaccines, Inc

INN (International Name):

CLINDAMYCIN PHOSPHATE

Composition:

CLINDAMYCIN 150 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products 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 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. CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of designated or

Product summary:

Each mL of CLEOCIN PHOSPHATE Sterile Solution contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate, 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. CLEOCIN PHOSPHATE is available in the following packages: CLEOCIN PHOSPHATE is supplied in ADD-Vantage vials as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. CLEOCIN PHOSPHATE IV Solution in GALAXY plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. The single dose GALAXY plastic containers are available as follows:

Authorization status:

New Drug Application

Summary of Product characteristics

CLEOCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
CLEOCIN PHOSPHATE®
(CLINDAMYCIN INJECTION, USP) AND
(CLINDAMYCIN INJECTION IN 5% DEXTROSE)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE
should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
STERILE SOLUTION IS FOR INTRAMUSCULAR AND INTRAVENOUS USE
CLEOCIN PHOSPHATE IN THE ADD-VANTAGE® VIAL IS FOR INTRAVENOUS USE
ONLY
WARNING
WARNING
_Clostridium difficile_-associated diarrhea (CDAD) has been reported
with use of
nearly all antibacterial agents, including CLEOCIN PHOSPHATE 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 CLEOCIN PHOSPHATE 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 evalua