CEFOTAXIME injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Wockhardt USA LLC.

INN (International Nazwa):

CEFOTAXIME SODIUM

Skład:

CEFOTAXIME 500 mg

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Treatment 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. (1) Lower respiratory tract infections , including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus 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 positive Proteus and Pseudomonas species (including P. aeruginosa ). (2) Genitourinary infections . Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis , Staphylococcus aureus *, (penicillinase and non-penicillinase producing), Citrobacter species,

Podsumowanie produktu:

Sterile 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: Package of 1               NDC 64679-947-01 Package of 10             NDC 64679-947-02 1 g cefotaxime (free acid equivalent) in vials in packages of: Package of 1               NDC 64679-986-01 Package of 10             NDC 64679-986-02 Package of 25             NDC 64679-986-03 Package of 50             NDC 64679-986-04 2 g cefotaxime (free acid equivalent) in vials in packages of: Package of 1               NDC 64679-948-01 Package of 10             NDC 64679-948-02 NOTE : Cefotaxime for injection, USP in the dry state, store at 20°-25°C (68°-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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFOTAXIME- CEFOTAXIME INJECTION, POWDER, FOR SOLUTION
WOCKHARDT USA LLC.
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PRESCRIBING INFORMATION
CEFOTAXIME FOR INJECTION, USP
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 5.0 to 7.5. The CAS Registry Number is 64485-93-4.
The molecular formula is C
H N NaO S and the molecular weight is 477.45. 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 ad