CEFUROXIME injection, powder, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

WG Critical Care, LLC

INN (Internationale Bezeichnung):

CEFUROXIME SODIUM

Zusammensetzung:

CEFUROXIME 750 mg

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

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 bottles as follows: Cefuroxime for Injection, USP equivalent to 750 mg or 1.5 grams cefuroxime per vial or infusion bottle. 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 bottle (Carton of 10) NDC 44567-722-10      1.5 gram infusion bottle (Carton of 10) Also available: Cefuroxime for Injection, USP Pharmacy Bulk Package equivalent to 7.5 grams of cefuroxime per Pharmacy Bulk Package bottle. NDC 44567-712-10      Pharmacy Bulk Package bottles - 7.5 grams (Carton of 10)

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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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, 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 vials or infusion bottles and is
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 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. The serum half-life after either IM or IV
injections is approximately 80 minutes.
Approximately 89% of a dose o