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:

ALMAJECT, INC.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clindamycin phosphate products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin 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. Clindamycin phosphate is indicated in the treatment of serious infections caused by susceptible strains of

Product summary:

Each mL of Clindamycin Injection, USP 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. Clindamycin Injection, USP is supplied in single dose vials as follows: Clindamycin Injection, USP is supplied as a Pharmacy Bulk Package as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION
ALMAJECT, INC.
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CLINDAMYCIN INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
clindamycin phosphate and other antibacterial drugs, clindamycin
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
WARNING
_Clostridioides difficile-_associated diarrhea (CDAD) has been
reported with use of
nearly all antibacterial agents, including clindamycin 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 clindamycin 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 evaluation should be instituted as clinically indicated.
DESCRIPTION
Clindamycin Injection, USP in vials contains clindamycin phosphate, a
water solubl