AZITHROMYCIN- azithromycin tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sandoz Inc

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Sammensætning:

AZITHROMYCIN ANHYDROUS 250 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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)] [See Use in Specific Populations (8.4) and Clinical Studies (14.2)] Azithromycin should not be used in patients with pneumonia

Produkt oversigt:

Azithromycin tablets, USP, equivalent to 250 mg azithromycin, are white, oval-shaped, unscored, film-coated tablets, debossed GG D6 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1496-31 in bottles of 30 tablets NDC 0781-1496-69 Unit Dose Package of 50 tablets NDC 0781-1496-68 Package of 18 tablets (3 x 6 unit-of-use blisters) Azithromycin tablets, USP, equivalent to 500 mg azithromycin, are white, oval-shaped, unscored, film-coated tablets, debossed GG D8 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-1941-31 in bottles of 30 tablets NDC 0781-1941-33 Package of 9 tablets (3 x 3 unit-of-use blisters) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
SANDOZ 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) 02/2016
INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial drug indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
•
•
•
•
•
•
•
•
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
DOSAGE AND ADMINISTRATION
•
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 mg once daily for 3 days.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
•
INFE C TIO N
RECOMMENDED DOSE/DURATION OF THERAPY
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days
or 10 mg/kg as a single dose on Day 1 followed by 5
mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
10 mg/kg once daily for 3 days.
Community-acquired pn