CEFTRIAXONE injection, powder, for solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

CEFTRIAXONE SODIUM (UNII: 023Z5BR09K) (CEFTRIAXONE - UNII:75J73V1629)

Հասանելի է:

Rebel Distributors Corp

INN (Միջազգային անվանումը):

CEFTRIAXONE SODIUM

Կազմը:

CEFTRIAXONE 500 mg

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Before instituting treatment with ceftriaxone for injection, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection and other antibacterial drugs, ceftriaxone for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for injection is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pne

Ապրանքի ամփոփագիր:

Ceftriaxone for injection is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 500 mg equivalent of ceftriaxone. Box of 1 (NDC 42254-152-10). Storage prior to reconstitution: Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CEFTRIAXONE- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
REBEL DISTRIBUTORS CORP
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CEFTRIAXONE FOR INJECTION, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ceftriaxone for
injection and other antibacterial drugs, ceftriaxone for injection
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ceftriaxone for injection is a sterile, semisynthetic, broad-spectrum
cephalosporin antibiotic for
intravenous or intramuscular administration. Ceftriaxone sodium is
(_6R,7R_)-7-[2-(2-Amino-4-
thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-_as_-triazin-3-yl)thio]methyl]-
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7
-(_Z_)-(_O_-methyloxime), disodium salt,
sesquaterhydrate.
The chemical formula of ceftriaxone sodium is C
H N Na O S •3.5 H O. It has a calculated
molecular weight of 661.59 and the following structural formula:
Ceftriaxone for injection is a white to yellowish-orange crystalline
powder which is readily soluble in
water, sparingly soluble in methanol and very slightly soluble in
ethanol. The pH of a 1% aqueous
solution is approximately 6.7. The color of ceftriaxone for injection
solutions ranges from light yellow
to amber, depending on the length of storage, concentration and
diluent used.
Ceftriaxone for injection contains approximately 83 mg (3.6 mEq) of
sodium per gram of ceftriaxone
activity.
CLINICAL PHARMACOLOGY
Average plasma concentrations of ceftriaxone following a single
30-minute intravenous (IV) infusion of
a 0.5, 1 or 2 g dose and intramuscular (IM) administration of a single
0.5 (250 mg/mL or 350 mg/mL
concentrations) or 1 g dose in healthy subjects are presented in Table
1.
TABLE 1. CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINIS TRATION
2
18
16
8
2
7
3
2
* IV doses were infused at a constant rate over 30 minutes.
ND = Not determined.
Dose/Route
Average Plasma Concentrations (mcg/mL)
0.5 hr
1 hr
2 hr
4 hr
6 hr
8 hr