Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
CEFTRIAXONE SODIUM (UNII: 023Z5BR09K) (CEFTRIAXONE - UNII:75J73V1629)
REMEDYREPACK INC.
CEFTRIAXONE SODIUM
CEFTRIAXONE 1 g
INTRAMUSCULAR
PRESCRIPTION DRUG
Before instituting treatment with Ceftriaxone for Injection, USP, 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, USP and other antibacterial drugs, Ceftriaxone for Injection, USP 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
Ceftriaxone for Injection, USP is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing ceftriaxone sodium equivalent to 250 mg ceftriaxone Box of 25 (NDC 0143-9859-25) Vials containing ceftriaxone sodium equivalent to 500 mg ceftriaxone Box of 25 (NDC 0143-9858-25) Vials containing ceftriaxone sodium equivalent to 1 gm ceftriaxone Box of 25 (NDC 0143-9857-25) Vials containing ceftriaxone sodium equivalent to 2 gm ceftriaxone Box of 25 (NDC 0143-9856-25) Note: Ceftriaxone for Injection, USP sterile powder should be stored at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature], and protected from light.
Abbreviated New Drug Application
CEFTRIAXONE- CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION REMEDYREPACK INC. ---------- 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, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 _R_,7 _R_)-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 •3.5H O. It has a calculated molecular weight of 661.59 and the following structural formula: Ceftriaxone for Injection, USP 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, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP 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 gm dose and intramuscular (IM) administration of a single 0.5 (250 mg/mL or 350 mg/mL concentrations) or 1 gm dose in healthy subjects are presented in TABLE 1. TABLE 1. CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE ADMINISTRATION Dose/Route Average Plasma Concentrations (mcg/mL) 0.5 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 16 hr 24 hr 2 18 16 8 2 7 3 2 0.5 gm IV* 82 59 48 37 29 23 15 10 5 0.5 g Đọc toàn bộ tài liệu