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:

Baxter Healthcare Corporation

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Clindamycin Injection USP in 5% Dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection USP in 5% Dextrose 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 Injection USP in 5% Dextrose is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae , other streptococci (except E. faecalis ), and Staphylococcus aureus . Skin and skin structure infections caused by Streptococcus pyogenes , Staphylococcus aureus , and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. Septicemia caused by Staphylococcus aureus , streptococci (except Enterococcus faecalis ), and susceptible anaerobes. Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin Injection USP in 5% Dextrose and other antibacterial drugs, Clindamycin Injection USP in 5% Dextrose should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Produkt oversigt:

Each 50 mL of Clindamycin Injection USP in 5% Dextrose contains Clindamycin phosphate, USP equivalent to 300 mg, 600 mg, or 900 mg clindamycin; 2.5 g dextrose hydrous, USP; 2 mg edetate disodium dihydrate, USP; and Water for Injection, USP. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. The single dose GALAXY containers are available as follows: Code Product Description NDC Number 2G3466 Supplied as 24 bags per case 600 mg per 50 mL NDC 43066-993-24 2G3467 Supplied as 24 bags per case 900 mg per 50 mL NDC 43066-995-24 Exposure of pharmaceutical products to heat should be minimized. It is recommended that GALAXY plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30°C.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLINDAMYCIN PHOSPHATE- CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
CLINDAMYCIN INJECTION USP IN 5% DEXTROSE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
CLINDAMYCIN INJECTION USP IN 5% DEXTROSE and other antibacterial
drugs,
CLINDAMYCIN INJECTION USP IN 5% DEXTROSE should be used only to treat
or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
STERILE SOLUTION IS FOR INTRAVENOUS USE
CLINDAMYCIN INJECTION USP IN 5% DEXTROSE IN THE GALAXY BAG IS FOR
INTRAVENOUS USE ONLY
WARNING
_Clostridioides difficile_-associated diarrhea (CDAD) has been
reported with use of
nearly all antibacterial agents, including Clindamycin Injection USP
in 5% Dextrose
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 Injection USP in 5% Dextrose 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.