CLINDAMYCIN- clindamycin phosphate injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

clindamycin phosphate (UNII: EH6D7113I8) (clindamycin - UNII:3U02EL437C)

Tilgængelig fra:

Cardinal Health

INN (International Name):

clindamycin phosphate

Sammensætning:

clindamycin 150 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 WARNING box, 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 des

Produkt oversigt:

Each mL of Clindamycin Injection, USP contains clindamycin phosphate equivalent to 150 mg of clindamycin. Also contains 0.5 mg disodium edetate; and 9.45 mg benzyl alcohol as a preservative. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. Clindamycin Injection, USP is supplied as follows: NDC Clindamycin Injection, USP (150 mg per mL) Package Factor 55154-2828-5 900 mg per 6 mL Single-Dose Vial Overbagged with 5 x 6 ml vials per bag   Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLINDAMYCIN- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION
CARDINAL HEALTH
----------
CLINDAMYCIN INJECTION, USP
SAGENT
Rx only
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.
STERILE SOLUTION IS FOR INTRAMUSCULAR AND INTRAVENOUS USE
WARNING
_Clostridium difficile_ associated diarrhea (CDAD) has been reported
with use of nearly all
antibacterial agents, including clindamycin 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, a clear colorless to pale yellow sterile
solution, contains c