CEFUROXIME injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CEFUROXIME SODIUM (UNII: R8A7M9MY61) (CEFUROXIME - UNII:O1R9FJ93ED)

Tilgjengelig fra:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CEFUROXIME SODIUM

Sammensetning:

CEFUROXIME 750 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Cefuroxime for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , and Escherichia coli . - Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. - Skin and Skin­-Structure Infections caused by Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pyogenes , Escherichia coli , Klebsiella spp., and Enterobacter spp. - Septicemia caused by Staphylococcus aureus (penicillinase- and non–penicillinase-producing strains), Streptococcus pneumoniae , Escherichia coli , Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. - Mening

Produkt oppsummering:

Cefuroxime for Injection, USP in the dry state should be stored at 20-25° (68-77°F) [see USP Controlled Room Temperature] and protected from light. Cefuroxime for Injection, USP, is a dry, white to off-white powder supplied as follows: NDC 0143-9568-25     Sterile Cefuroxime Sodium USP, 750 mg                     Carton of 25                                         Equivalent to Cefuroxime, IM/IV Injection     NDC 0143-9567-25     Sterile Cefuroxime Sodium USP, 1.5 grams                 Carton of 25                                         Equivalent to Cefuroxime, IV Injection Also available as: NDC 0143-9569-10     Sterile Cefuroxime Sodium USP, 7.5 grams                 Carton of 10                                         Equivalent to Cefuroxime, Pharmacy Bulk Package

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
WEST-WARD PHARMACEUTICALS CORP
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CEFUROXIME FOR INJECTION, USP
Rx ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefuroxime for
Injection and other antibacterial drugs, Cefuroxime for Injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin
antibiotic for parenteral
administration. It is the sodium salt of
(6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-
yl)acetamido]ceph-3-em-4-carboxylate, and it has the following
structural formula:
The molecular formula is C
H N NaO S, representing a molecular weight of 446.4.
Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq)
of sodium per gram of
cefuroxime activity.
Cefuroxime for Injection, USP in sterile crystalline form is supplied
in vials equivalent to 750 mg or
1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for
Injection, USP range in color
from light yellow to amber, depending on the concentration and diluent
used. The pH of freshly
constituted solutions usually ranges from 6 to 8.5.
CLINICAL PHARMACOLOGY
After intramuscular (IM) injection of a 750-mg dose of cefuroxime to
normal volunteers, the mean peak
serum concentration was 27 mcg/mL. The peak occurred at approximately
45 minutes (range, 15 to
60 minutes). Following IV doses of 750 mg and 1.5 grams, serum
concentrations were approximately 50
and 100 mcg/mL, respectively, at 15 minutes. Therapeutic serum
concentrations of approximately
2 mcg/mL or more were maintained for 5.3 hours and 8 hours or more,
respectively. There was no
evidence of accumulation of cefuroxime in the serum following IV
administration of 1.5-g doses every
8 hours to normal volunteers. The serum half-life after either IM or
IV injections is approximately
80 minutes.
Approximately 89% of a dose of cefuroxime is excreted by the kidneys
over