Country: United States
Language: English
Source: NLM (National Library of Medicine)
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
Major Pharmaceuticals
AZITHROMYCIN DIHYDRATE
AZITHROMYCIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
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 therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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)] . [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] Azithromycin should not be used in patients wi
Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin Tablets, USP 250 mg are engraved “APO” on one side and “AZ250” on the other side. These are packaged in bottles and blister cards of 6 tablets as follows: Carton of 50 tablets (10 tablets each blister pack x 5) , NDC 0904-6405-06 Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6405-61 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
AZITHROMYCIN DIHYDRATE- AZITHROMYCIN TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- 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) 02/2016 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacte ria: 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. DOSAGE AND ADMINISTRATION 2. 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 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. 2. INFE C TIO N RECOMMENDED DOSE/DURATION OF THERAPY Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. Acute bacterial sinusitis 10 mg/kg once daily for 3 days. Community-acquired pneumonia 10 mg Read the complete document