CEFUROXIME injection, powder, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

WG Critical Care, LLC

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Cefuroxime for Injection, USP 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. - Meningitis

제품 요약:

Store Cefuroxime for Injection, USP at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect From Light. Cefuroxime for Injection, USP is a dry, white to off-white powder supplied in vials and infusion packs as follows: Cefuroxime for Injection, USP. Cefuroxime sodium equivalent to 7.5 grams of cefuroxime per Pharmacy Bulk Package. NDC 44567-712-10       7.5 gram vial Pharmacy Bulk Pack (Carton of 10) Also available: Cefuroxime for Injection, USP. Cefuroxime sodium equivalent to 750 mg or 1.5 grams cefuroxime per vial or infusion pack. NDC 44567-710-10       750 mg vial (Carton of 10) NDC 44567-711-10       1.5 gram vial (Carton of 10) NDC 44567-720-10       750 mg infusion pack (Carton of 10) NDC 44567-722-10       1.5 gram infusion pack (Carton of 10)  

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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CEFUROXIME FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefuroxime for
Injection, USP and other antibacterial drugs, Cefuroxime for
Injection, USP should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by bacteria.
DESCRIPTION
Cefuroxime for Injection, USP 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 chemical structure:
The empirical 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 Pharmacy Bulk Package
equivalent to 7.5 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.
A pharmacy bulk package is a container of a sterile powder for
parenteral use that contains many single
doses. The contents are intended for use in a pharmacy admixture
service and are restricted to the
preparation of admixtures for intravenous infusion. FURTHER DILUTION
IS REQUIRED BEFORE
USE.
CLINICAL PHARMACOLOGY
Following IV doses of 750 mg and 1.5 g, 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.