CEFOXITIN AND DEXTROSE- cefoxitin sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEFOXITIN SODIUM (UNII: Q68050H03T) (CEFOXITIN - UNII:6OEV9DX57Y)

Available from:

B. Braun Medical Inc.

INN (International Name):

CEFOXITIN SODIUM

Composition:

CEFOXITIN 1 g in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli , Klebsiella species, Haemophilus influenzae , and Bacteroides species. Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of urinary tract infections caused by Escherichia coli , Klebsiella species, Proteus mirabilis , Morganella morganii , Proteus vulgaris and Providencia species (including P. rettgeri ). Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species. Cefoxi

Product summary:

How Supplied Cefoxitin for Injection and Dextrose Injection in the DUPLEX® Container is a flexible dual chamber single-dose container supplied in two concentrations. After reconstitution, the delivered doses are equivalent to 1 g and 2 g cefoxitin. The diluent chamber contains approximately 50 mL of Dextrose Injection. Dextrose Injection has been adjusted to 4% w/v and 2.2% w/v for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic. Cefoxitin for Injection and Dextrose Injection is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP). Storage Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze. As with other cephalosporins, reconstituted Cefoxitin for Injection and Dextrose Injection tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Use only if prepared solution is clear and free from particulate matter.

Authorization status:

New Drug Application

Summary of Product characteristics

CEFOXITIN AND DEXTROSE- CEFOXITIN SODIUM INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFOXITIN FOR INJECTION AND DEXTROSE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEFOXITIN FOR INJECTION AND DEXTROSE
INJE C TIO N.
CEFOXITIN FOR INJECTION AND DEXTROSE INJECTION,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
Cefoxitin for Injection and Dextrose Injection is a cephalosporin
antibacterial indicated for the treatment of the following
infections caused by susceptible isolates of the designated bacteria
(1):
Lower respiratory tract infections (1.1);
Urinary tract infections (1.2);
Intra-abdominal infections (1.3);
Gynecological infections (1.4);
Septicemia (1.5);
Bone and joint infections (1.6);
Skin and skin structure infections (1.7);
Prophylaxis (1.8).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefoxitin for Injection and
Dextrose Injection and other antibacterial drugs, Cefoxitin for
Injection and Dextrose Injection should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by bacteria (1.9).
DOSAGE AND ADMINISTRATION
For intravenous use only. (2)
Use this formulation of cefoxitin only in patients who require the
entire 1 or 2 gram dose and not any fraction thereof.
(2.3)
See full prescribing information for dose adjustment in patients with
impaired renal function. (2.3)
Recommended dosing schedule in patients with normal renal function.
(2.1)
DOSAGE FORMS AND STRENGTHS
Single-dose DUPLEX Container consisting of:
1 g cefoxitin for injection and 50 mL 5% dextrose injection (3)
2 g cefoxitin for injection and 50 mL 5% dextrose injection (3)
CONTRAINDICATIONS
Hypersensitivity to cefoxitin or other beta-lactam antibacterial
drugs. (4.1)
Hypersensitivity to corn products. (4.2)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including anaphylaxis and serious skin
reac