Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
NuCare Pharmaceuticals, Inc.
AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN ANHYDROUS 250 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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [ see Dosage and Administration ( 2) ]. - Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . - Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . - Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. - Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - Uncomplicated skin and skin structure infecti
Azithromycin tablets USP are available as follows: 250 mg: Mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7146” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP. They are available in bottles of 30 tablets bottles of 4 NDC 68071-3006-4 bottles of 2 NDC 68071-3006-2 Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED NUCARE PHARMACEUTICALS, 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, Hypersensitivity ( 5.1) 5/2016 Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis ( 5.3) 7/2016 INDICATIONS AND USAGE Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1) Acute bacterial sinusitis in adults ( 1.1) Uncomplicated skin and skin structure infections in adults ( 1.1) Urethritis and cervicitis in adults ( 1.1) Genital ulcer disease in men ( 1.1) Acute otitis media in pediatric patients ( 1.2) Community-acquired pneumonia in adults and pediatric patients ( 1.1, 1.2) Pharyngitis/tonsillitis in adults and pediatric patients ( 1.1, 1.2) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. ( 1.3) 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 infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.4) DOSAGE AND ADMINISTRATION ADULT PATIENTS ( 2.1) INFE C TIO N RECOMMENDED DOSE/DURATION OF THERAPY Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacterial exacerbations of chronic bronchitis (mild to mode rate ) 500 mg as a single dose on Day 1, followed by 250 mg once dai Preberite celoten dokument