Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Hospira, Inc.
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN ANHYDROUS 500 mg
INTRAVENOUS
PRESCRIPTION DRUG
Azithromycin for Injection, USP 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. Azithromycin for Injection, USP should be followed by azithromycin the oral route as required [see Dosage and Administration (2) ]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial dr
Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose ADD-Vantage® vial equivalent to 500 mg of azithromycin for intravenous administration. These are packaged as follows: Store the lyophilized cake at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HOSPIRA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZITHROMYCIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN. AZITHROMYCIN FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2009 RECENT MAJOR CHANGES Warnings and Precautions, Cardiovascular Death (5.5) 11/2021 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3) DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Azithromycin for Injection is supplied as white to off-white lyophilized powder in a single-dose ADD- Vantage vial equivalent to 500 mg of azithromycin for intravenous administration. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS Serious (including fatal) allergic 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 Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. (5.3) Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions and with other Lue koko asiakirja