CLINDAMYCIN- clindamycin phosphate injection, solution, concentrate

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Medical Purchasing Solutions, LLC

INN (שם בינלאומי):

CLINDAMYCIN PHOSPHATE

הרכב:

CLINDAMYCIN PHOSPHATE 150 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 str

leaflet_short:

Each mL of Clindamycin Injection USP (150 mg/mL) contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin Injection, USP (150 mg/mL) is supplied as follows: Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature.] Do not refrigerate.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

CLINDAMYCIN- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE
MEDICAL PURCHASING SOLUTIONS, LLC
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TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
CLINDAMYCIN AND OTHER ANTIBACTERIAL DRUGS, CLINDAMYCIN SHOULD BE USED
ONLY TO TREAT OR PREVENT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY
BACTERIA. CLINDAMYCIN INJECTION
USP 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 water soluble ester of clindamycin and
phosphoric acid, is a sterile
solution for intramu