AZITHROMYCIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

PD-Rx Pharmaceuticals, Inc.

INN (mednarodno ime):

AZITHROMYCIN MONOHYDRATE

Sestava:

AZITHROMYCIN ANHYDROUS 500 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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 43063-540-79 in bottles of 1 tablets NDC 43063-540-02 in bottles of 2 tablets NDC 43063-540-03 in bottles of 3 tablets NDC 43063-540-05 in bottles of 5 tablets NDC 43063-540-07 in bottles of 7 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
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:
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
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 through 5 or 500 mg once daily for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
Ge