国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Fresenius Kabi USA, LLC
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN ANHYDROUS 500 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to Chlamydophila pneumoniae , Haemophilus influenzae , Legionella pneumophila , Moraxella catarrhalis , Mycoplasma pneumoniae , Staphylococcus aureus , or Streptococcus pneumoniae in patients who require initial intravenous therapy. 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 Azithromycin for injection. Azithromycin for injection should be followed by Azithromycin by the oral route as required.
Azithromycin for injection, USP is supplied in lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. Each vial also contains sodium hydroxide and 413.6 mg citric acid. This container closure is not made with natural rubber latex. Storage Store the white to off-white lyophilized cake at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. When diluted according to the instructions (1 mg/mL to 2 mg/mL), azithromycin for injection, USP is stable for 24 hours at or below room temperature 30ºC (86ºF), or for 7 days if stored under refrigeration 5ºC (41ºF).
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZITHROMYCIN FOR INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN FOR INJECTION, USP. AZITHROMYCIN FOR INJECTION, USP, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE Azithromycin for injection, USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Community-acquired pneumonia in adults ( 1.1) Pelvic inflammatory disease ( 1.2) TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AZITHROMYCIN FOR INJECTION, USP AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN FOR INJECTION, USP SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA. DOSAGE AND ADMINISTRATION Community-acquired pneumonia: 500 mg as a single daily dose by the intravenous route for at least two days. ( 2.1) Pelvic inflammatory disease in adults: 500 mg as a single daily dose by the intravenous route for one or two days. ( 2.2) DOSAGE FORMS AND STRENGTHS Azithromycin for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. ( 3) CONTRAINDICATIONS Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibacterial drug. ( 4.1) Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ( 4.2) WARNINGS AND PRECAUTIONS Serious (including fatal) allergic reactions and skin reactions. Discontinue azithromycin and initiate appropriate therapy if reaction occurs. ( 5.1) Hepatotoxicity: Severe and sometimes fatal, hepatoxicity has been reported. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. ( 5.2) Infantile Hypertroph 阅读完整的文件