CEFTRIAXONE injection, powder, for solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Cephazone Pharma LLC

INN (Jina la Kimataifa):

CEFTRIAXONE SODIUM

Tungo:

CEFTRIAXONE 250 mg

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Before instituting treatment with ceftriaxone, 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 and other antibacterial drugs, ceftriaxone 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, USP is indicated for the treatment of the following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemop

Bidhaa muhtasari:

Ceftriaxone for Injection, USP is available as a sterile crystalline powder in glass vials and piggyback bottles. The following packages are available: Vials containing 250 mg equivalent of ceftriaxone. Box of 1 (NDC No. 68330-001 -01) and box of 10 (NDC No. 68330-001-10) Vials containing 500 mg equivalent of ceftriaxone. Box of 1 (NDC No. 68330-002-01) and box of 10 (NDC No. 68330-002-10) Vials containing 1 g equivalent of ceftriaxone. Box of 1 (NDC No.68330-003-01) and box of 10 (NDC No. 68330-003-10) Vials containing 2 g equivalent of ceftriaxone. Box of 1 (NDC No.68330-004-01) and box of 10 (NDC No. 68330-004-10) Piggyback bottles containing 1 g equivalent of ceftriaxone. Box of 1 (NDC No.68330-005-01) and box of 10(NDC NO. 68330-005-10) Piggyback bottles containing 2 g equivalent of ceftriaxone. Box of 1 (NDC No. 68330-006-01) and box of 10(NDC No. 68330-006-10) NOTE: Ceftriaxone for injection, USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CEFTRIAXONE - CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION
CEPHAZONE PHARMA LLC
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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 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-[[(l,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-l-
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 0 S ·3.5H 0. It has a calculated
molecular weight of 661.60 and the following structural formula:
Ceftriaxone 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 solutions ranges from
light yellow to amber, depending on
the length of storage, concentration and diluent used.
Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1
gram, or 2 grams of ceftriaxone.
Each piggyback bottle contains ceftriaxone sodium equivalent to 1 gram
or 2 grams of ceftriaxone.
Ceftriaxone 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
ADMINISTRATION.
Average Plasma Concentrations (mcg/mL)
Dose/Ro