AZITHROMYCIN tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Aidarex Pharmaceuticals LLC

INN（国际名称）:

AZITHROMYCIN MONOHYDRATE

组成:

AZITHROMYCIN ANHYDROUS 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 influenzae , Moraxella catarrhalis , or Streptoc

產品總結:

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: Dispense in a tight container

授权状态:

Abbreviated New Drug Application

产品特点

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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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 TABLETS, USP.
AZITHROMYCIN TABLETS, USP 250 MG AND 500 MG
INITIAL U.S. APPROVAL: 1991
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
INFE C TIO N
RECOMMENDED DOSE/DURATION OF THERAPY
Community-acquired pneumonia (mild
severity) (2)
Pharyngitis/tonsillitis (second-line therapy)
(2)
Skin/skin structure (uncomplicated) (2)
500 mg as a single dose on Day 1, followed by 250 mg once daily on
Days 2
through 5. (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)