AZITHROMYCIN tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Unit Dose Services

INN (Nama Internasional):

AZITHROMYCIN ANHYDROUS

Komposisi:

AZITHROMYCIN ANHYDROUS 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Product: 50436-4356 NDC: 50436-4356-1 18 TABLET, FILM COATED in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
UNIT DOSE SERVICES
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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
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)
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 day