AZITHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medsource Pharmaceuticals

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP 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 tablets USP are 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

Product summary:

Azithromycin tablets USP, 250 mg are supplied as white, oval, biconvex, unscored, film-coated tablets, debossed with “787” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP, available in boxes of 1 card x 6 tablets and in a bundle of 3 boxes x 6 tablets (18). Azithromycin tablets USP, 500 mg are supplied as blue, capsule shaped, biconvex, unscored, film-coated tablets, debossed with “788” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 500 mg of azithromycin, USP, available in boxes of 1 card x 3 tablets and in a bundle of 3 boxes x 3 tablets (9). Store at 20º to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
MEDSOURCE PHARMACEUTICALS
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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 USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Azithromycin tablets USP are 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 TABLETS
USP AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN TABLETS USP SHOULD BE
USED ONLY TO TREAT INFECTIONS THAT ARE
PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA
DOSAGE AND ADMINISTRATION
ADULT PATIENTS
INFECTION (2)
RECOMMENDED DOSE/DURATION OF THERAPY (2)
Community-acquired pneumonia (mild severity)
Pharyngitis/tonsillitis (second-line therapy) 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 (