AZITHROMYCIN MONOHYDRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 500 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 and other antibacterial drugs, azithromycin tablets 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 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 is supplied in the following strengths and package configurations: Azithromycin tablets USP, 500 mg are supplied as pink, oval shaped film-coated tablets, engraved with "LU" on one side and "L12" on the other side containing azithromycin monohydrate USP equivalent to 500 mg of azithromycin USP. These are packaged in bottles and blister cards as follows: bottles of 6 NDC 68071-3169-6 bottles of 5 NDC 68071-3169-5 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET
NUCARE PHARMACEUTICALS, INC.
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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, 250 MG AND 500 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity ( 5.1) 2/2016
INDICATIONS AND USAGE
Azithromycin tablets 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
AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN TABLETS 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)
INFECTION
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 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 b