AZITHROMYCIN- azithromycin tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Cardinal Health

INN (שם בינלאומי):

AZITHROMYCIN DIHYDRATE

הרכב:

AZITHROMYCIN ANHYDROUS 250 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

AZITHROMYCIN is supplied in the following strengths and package configurations: AZITHROMYCIN 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. AZITHROMYCIN 250 mg tablets are engraved with "G" on one side and "3060" on the other. These are packaged overbagged with 10 tablets per bag, NDC 55154-0525-0. AZITHROMYCIN tablets should be stored between 15° to 30°C (59° to 86°F). Repackaged By: Cardinal Health Zanesville, OH 43701 Storage: Store dry powder below 30°C (86°F). Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

מצב אישור:

New Drug Application Authorized Generic

מאפייני מוצר

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
CARDINAL HEALTH
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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 AND 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:
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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 (azithromycin)
and other antibacterial drugs, AZITHROMYCIN (azithromycin) should be
used only to treat infections that are proven or
strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
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INFE C TIO N
RECOMMENDED DOSE/DURATION OF
T HERAPY
Community-acquired pneumonia (mild
severity) (2)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
(2)
Pharyngitis/tonsillitis (second-line therapy)
(2)
Skin/skin structure (uncomplicated) (2)
Acute bacterial exacerbations of chronic
bronchitis (mild to moderate) (2)
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. (2)
Acute bacterial sinusitis (2)
500 mg once daily for 3 days. (2)
Genital ulcer disease (chancroid) Non-
gonococcal urethritis and cervicitis (2)
One single 1 gram dose. (2)
Gonococcal urethritis and cervicitis (2)
One single 2 gram dose. (2)
•
INFE C TIO N
RECOMMENDED DOSE/DURATION OF
T HERAPY
Acute otitis media (2)
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. (2)
Acute bacterial sinusitis (2)
10 mg/kg once daily for 3