Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Sandoz Inc
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN ANHYDROUS 600 mg
ORAL
PRESCRIPTION DRUG
Azithromycin tablets 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. Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablets, 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 tablets, 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 tablets and other antibacterial drugs, azithromycin tabl
Azithromycin tablets, USP, equivalent to 600 mg azithromycin, are unscored white, oval-shaped, film-coated tablets, debossed GG D7 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-5793-31 in bottles of 30 tablets Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED SANDOZ INC ---------- 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. AZITHROMYCIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Cardiovascular Death (5.5) 07/2021 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial 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 • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS The most common adverse reactions are diarrhea (5%), nausea (3%), abdominal pain (3%), or vomiting, (no percent given). (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT 1-800-525-8747 OR FDA Sexually Transmitted Diseases (1.1) Mycobacterial Infections (1.2) Sexually Transmitted Diseases (2.1) Mycobacterial Infections (2.2) Azithromycin Tablets 600 mg (3) 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) 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 Lesen Sie das vollständige Dokument