Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
AvPAK
Azithromycin Anhydrous
Azithromycin Anhydrous 250 mg
ORAL
PRESCRIPTION DRUG
Azithromycin is 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
Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg. Available as follows: (NDC 50268-098-15) 10 Tablets per card, 5 cards per carton. Azithromycin tablets 500 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W964 on one side and other side plain containing anhydrous azithromycin 500 mg. Available as follows: (NDC 50268-098-13) 10 Tablets per card, 3 cards per carton. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispensed in Unit Dose Package. For Institutional Use Only.
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED AVPAK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION AZITHROMYCIN TABLETS 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) 3/2017 Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis ( 5.3) 2/2017 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacte ria: 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 and other antibacterial drugs, azithromycin 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) INFECTION 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 moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg Lees het volledige document