AZITHROMYCIN tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Saatavilla:

Bryant Ranch Prepack

INN (Kansainvälinen yleisnimi):

AZITHROMYCIN DIHYDRATE

Koostumus:

AZITHROMYCIN ANHYDROUS 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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 due to St

Tuoteyhteenveto:

Product: 63629-6764 NDC: 63629-6764-1 2 TABLET, FILM COATED in a BOTTLE NDC: 63629-6764-2 14 TABLET, FILM COATED in a BOTTLE

Valtuutuksen tilan:

New Drug Application Authorized Generic

Valmisteyhteenveto

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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
INDICATIONS AND USAGE
AZITHROMYCIN is 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 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
mode rate )
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