Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Wockhardt USA LLC.
AZITHROMYCIN ANHYDROUS
AZITHROMYCIN ANHYDROUS 600 mg
ORAL
PRESCRIPTION DRUG
Azithromycin tablets, USP are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablet, USP taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)]. Treatment of Disseminated MAC Disease Azithromycin tablet, USP taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)]. To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, az
Azithromycin tablets USP, 600 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W962 on one side and other side plain containing anhydrous azithromycin 600 mg. These are packaged as follows: Bottles of 30: NDC 64679-962-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
AZITHROMYCIN - AZITHROMYCIN TABLET, FILM COATED WOCKHARDT USA LLC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZITHROMYCIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN TABLETS.<BR><BR>AZITHROMYCIN TABLETS, FOR ORAL USE<BR>INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Cardiovascular Death ( 5.5) 11/2021 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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 Mycobacterial Infections ( 2.2) DOSAGE FORMS AND STRENGTHS Azithromycin tablets 600 mg ( 3) CONTRAINDICATIONS Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic. ( 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 and skin reactions. Discontinue azithromycin and initiate appropriate therapy if reaction occurs. ( 5.1) Hepatotoxicity: 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 prolo Прочитајте комплетан документ