CEFOTAXIME- cefotaxime injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7)

Tilgjengelig fra:

Lupin Pharmaceuticals, Inc.

INN (International Name):

CEFOTAXIME SODIUM

Sammensetning:

CEFOTAXIME 500 mg

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Cefotaxime for Injection USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Lower respiratory tract infections , including pneumonia, caused byStreptococcus pneumoniae (formerlyDiplococcus pneumoniae ),Streptococcus pyogenes * (Group A streptococci) and other streptococci (excluding enterococci, e.g.,Enterococcus faecalis ),Staphylococcus aureus (penicillinase and non-penicillinase producing),Escherichia coli ,Klebsiella species,Haemophilus influenzae (including ampicillin resistant strains),Haemophilus parainfluenzae ,Proteus mirabilis ,Serratia marcescens *,Enterobacter species, indole positiveProteus andPseudomonas species (includingP. aeruginosa ). - Genitourinary infections . Urinary tract infections caused byEnterococcus species,Staphylococcus epidermidis ,Staphylococcus aureus *, (penicillinase and non-penicillinase producing),Citrobacter species,Enterobacter species,Escherichia coli ,Kl

Produkt oppsummering:

Cefotaxime for Injection USP is a dry off-white to pale yellow crystalline powder supplied in vials containing cefotaxime sodium as follows: 500 mg cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 68180-811-10). 1 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 68180-822-10), packages of 25 (NDC 68180-822-25), packages of 50 (NDC 68180-822-50). 2 g cefotaxime (free acid equivalent) in vials in packages of 10 (NDC 68180-833-10), packages of 25 (NDC 68180-833-25), packages of 50 (NDC 68180-833-50). NOTE:   Cefotaxime for injection USP in the dry state should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. The dry material as well as solutions tend to darken depending on storage conditions and should be protected from elevated temperatures and excessive light.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CEFOTAXIME- CEFOTAXIME INJECTION, POWDER, FOR SOLUTION
LUPIN PHARMACEUTICALS, INC.
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CEFOTAXIME FOR INJECTION USP
500 MG, 1 G AND 2 G
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefotaxime for
injection and other antibacterial drugs, cefotaxime for injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cefotaxime for Injection USP is a semisynthetic, broad spectrum
cephalosporin antibiotic for parenteral
administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl)
glyoxylamido]-3-(hydroxymethyl)-8-
oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72
(Z)-(o-methyloxime), acetate (ester).
Cefotaxime for injection USP contains approximately 50.5 mg (2.2 mEq)
of sodium per gram of
cefotaxime activity. Solutions of cefotaxime for injection USP range
from very pale yellow to light
amber depending on the concentration and the diluent used. The pH of
the injectable solutions usually
ranges from 5 to 7.5. The CAS Registry Number is 64485-93-4.
Cefotaxime for injection USP is supplied as a dry powder in
conventional vials. Each vial contains
cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime.
CLINICAL PHARMACOLOGY
Following IM administration of a single 500 mg or 1 g dose of
cefotaxime for injection to normal
volunteers, mean peak serum concentrations of 11.7 and 20.5 mcg/mL
respectively were attained within
30 minutes and declined with an elimination half-life of approximately
1 hour. There was a dose-
dependent increase in serum levels after the IV administration of 500
mg, 1 g, and 2 g of cefotaxime for
injection (38.9, 101.7, and 214.4 mcg/mL respectively) without
alteration in the elimination half-life.
There is no evidence of accumulation following repetitive IV infusion
of 1 g doses every 6 hours for
14 days as there are no alterations of serum or renal clearance. About
60% of the administered dose
was recovered from urine during the first 6 hours f