AZITHROMYCIN tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

থেকে পাওয়া:

Teva Pharmaceuticals USA, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 infections

পণ্য সারাংশ:

Azithromycin Tablets USP, 250 mg are supplied as white, oval, biconvex, film-coated tablets, debossed with “787” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP, available in boxes of 1 card x 6 tablets (NDC 50111-787-51), in a bundle of 3 boxes x 6 tablets (18) (NDC 50111-787-66), and in bottles of 30 tablets (NDC 50111-787-10). Azithromycin Tablets USP, 500 mg are supplied as blue, capsule shaped, biconvex, film-coated tablets, debossed with “788” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin, USP, available in boxes of 1 card x 3 tablets (NDC 50111-788-55), in a bundle of 3 boxes x 3 tablets (9) (NDC 50111-788-67), and in bottles of 30 tablets (NDC 50111-788-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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
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 (6 months of age and older)
(1.2)
Community-acquired pneumonia in adults and pediatric patients (6
months of age and older) (1.1, 1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of
age and older) (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)
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 o