CEFUROXIME injection, powder, for solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Hikma Pharmaceuticals USA Inc.

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 caused

Ringkasan produk:

Cefuroxime for Injection, USP in the dry state should be stored at 20-25°C (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  0143-9976-03     Sterile Cefuroxime Sodium USP, 7.5 grams                       Carton of 10                                         Equivalent to Cefuroxime, Pharmacy Bulk Package Also available as: NDC  0143-9979-22      Sterile Cefuroxime Sodium USP, 750 mg                           Carton of 25                                          Equivalent to Cefuroxime, IM/IV Injection NDC  0143-9977-22      Sterile Cefuroxime Sodium, USP 1.5 grams                       Carton of 25                                         Equivalent to Cefuroxime, IV Injection

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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CEFUROXIME FOR INJECTION, USP
Rx Only
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
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, 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
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
as 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 preparation 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
16
15
4
8
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 g, serum concentrations were approximately 50 and 100 mcg/mL,
respectively, at
15 minutes. Therapeutic serum concentrations of approximately 2 mcg/mL
or more