AZITHROMYCIN tablet, film coated AZITHROMYCIN powder, for suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Department of State Health Services, Pharmacy Branch

ІПН (Міжнародна Ім'я):

AZITHROMYCIN DIHYDRATE

Склад:

AZITHROMYCIN ANHYDROUS 250 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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)] - Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influen

Огляд продуктів:

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 in bottles and blister cards of 6 tablets as follows: AZITHROMYCIN 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. AZITHROMYCIN 500 mg tablets are engraved with "G" on one side and "3070" on the other. These are packaged in bottles and blister cards of 3 tablets as follows: AZITHROMYCIN tablets should be stored between 15° to 30°C (59° to 86°F). AZITHROMYCIN for oral suspension after constitution contains a flavored suspension. AZITHROMYCIN for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: [see Dosage and Administration (2)] for constitution instructions with each bottle type. 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.

Статус Авторизація:

New Drug Application Authorized Generic

Характеристики продукта

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
----------
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 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:
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 (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
ADULT PATIENTS
INFE C TIO N
RECOMMENDED DOSE/DURATION OF
T HERAPY
Community-acquired pneumonia (mild
se ve rity)
500 mg as a single dose on Day 1, followed
by 250 mg once daily on Days 2 through 5.
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
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 days.
Acute bacterial sinusitis
500 mg once da