Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
REMEDYREPACK INC.
AZITHROMYCIN DIHYDRATE
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 . 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 pne
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: Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. Azithromycin Tablets, USP 500 mg are engraved “APO” on one side and “AZ500” on the other. These are packaged in bottles and blister cards of 3 tablets as follows: Storage: Store at 20ºC to 25ºC (68ºF to 77º F); excursions permitted from 15ºC to 30ºC (59ºF to 86º F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
AZITHROMYCIN DIHYDRATE- AZITHROMYCIN TABLET, FILM COATED REMEDYREPACK 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) 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) 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 50 সম্পূর্ণ নথি পড়ুন