Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (Azithromycin Anhydrous - UNII:J2KLZ20U1M)
APOTEX CORP.
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN 500 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
Azithromycin for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for dosing recommendations. Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy. Pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with a
Azithromycin for injection is supplied in lyophilized form under a vacuum in a 10 mL vial (NDC 60505-6076-4) equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains 384.5 mg of citric acid and sodium hydroxide. These are packaged as follows: 10 vials of 500 mg NDC 60505-6076-4 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Normosol®-M in 5% dextrose and Normosol®-R in 5% dextrose are the trademarks of Hospira.
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN FOR INJECTION INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INJECTION APOTEX CORP. ---------- AZITHROMYCIN FOR INJECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other bacterial drugs, azithromycin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Azithromycin for injection contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name ( _2R,3S,4R,5R,8R,10R,11R,12S,13S,14R_)-13-[(2,6-dideoxy-3- _C_-methyl-3- _O_-methyl-a-L- _ribo_- hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3- (dimethylamino)-ß- _D_- _xylo_-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl- substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C H N O , and its molecular weight is 749. Azithromycin has the following structural formula: Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C H N O .H O and a molecular weight of 767. Azithromycin for injection consists of azithromycin monohydrate and the following inactive ingredients: citric acid and sodium hydroxide. Azithromycin for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin, 384.5 mg of citric acid, and sodium hydroxide for pH adjustment. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing 100 mg azithromycin (from azithromycin monohydrate). CLINICAL PHARMACOLOGY PHARMACOKINETICS In patients hospitalized with community-acquired pneumonia receiving single daily one-hour intravenous infusions for 2 to 5 days of 500 mg azithromycin at a concentration of Прочитайте повний документ