País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Greenstone LLC
AZITHROMYCIN DIHYDRATE
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)] [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] 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 such as any of the following: 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial t
Azithromycin is supplied in the following strengths and package configurations: 250 mg (containing azithromycin dihydrate equivalent to 250 mg of azithromycin) Pink modified capsular shaped, engraved, film-coated Engraved with "G" on one side and "3060" on the other Bottles of 30 Boxes of 3 blister cards (6 tablets per blister card) Unit Dose package of 50 NDC 59762-3060-2 NDC 59762-3060-1 NDC 59762-3060-3 Engraved with "Pfizer" on one side and "ZTM 250" on the other Bottles of 30 Boxes of 3 blister cards (6 tablets per blister card) NDC 59762-2198-7 NDC 59762-2198-3 500 mg (containing azithromycin dihydrate equivalent to 500 mg of azithromycin) Pink modified capsular shaped, engraved, film-coated Engraved with "G" on one side and "3070" on the other Bottles of 30 Boxes of 3 blister cards (3 tablets per blister card) NDC 59762-3070-2 NDC 59762-3070-1 Azithromycin tablets should be stored between 15° to 30°C (59° to 86°F). Azithromycin for oral suspension after constitution contains a flavored suspension. Azithromycin for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: 300 mg 59762-3110-1 600 mg 59762-3120-1 900 mg 59762-3130-1 1200 mg 59762-3140-1 [see Dosage and Administration (2)] for constitution instructions with each bottle type. Storage: Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.
New Drug Application Authorized Generic
AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION GREENSTONE LLC ---------- 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 250 MG AND 500 MG TABLETS, FOR ORAL USE AZITHROMYCIN FOR ORAL SUSPENSION 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 drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • • • • • • • • 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) DOSAGE AND ADMINISTRATION • 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 once daily for 3 days. Acute bacterial sinusitis 500 mg once daily for 3 days. Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis One single 1 gram dose. Gonococcal urethritis and cervicitis One single 2 gram dose. • INFECTION RECOMMENDED DOSE/DURATION OF THERAPY 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 (6 months of age and older) (1.2) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older Llegiu el document complet