AZITHROMYCIN- azithromycin tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

REMEDYREPACK INC.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 infecti

Ապրանքի ամփոփագիր:

Azithromycin tablets USP are available as follows: 250 mg: Mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7146” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP. They are available in bottles of 30 tablets (NDC 0093-7146-56). 500 mg: Mottled pink, unscored, film-coated, modified-oval-shaped tablets, debossed with “93” on one side and “7169” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin, USP. They are available in bottles of 30 tablets (NDC 0093-7169-56). Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
REMEDYREPACK 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
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 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 ( 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 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)
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