AZITHROMYCIN tablet, film coated AZITHROMYCIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

INN (International Name):

AZITHROMYCIN DIHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] 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 such as any of the following: 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 t

Product summary:

Azithromycin is supplied in the following strengths and package configurations: 250 mg (containing azithromycin dihydrate equivalent to 250 mg of azithromycin) Pink modified capsular shaped, engraved, film-coated Engraved with "G" on one side and "3060" on the other Bottles of 30 Boxes of 3 blister cards (6 tablets per blister card) Unit Dose package of 50 NDC 59762-3060-2 NDC 59762-3060-1 NDC 59762-3060-3 Engraved with "Pfizer" on one side and "ZTM 250" on the other Bottles of 30 Boxes of 3 blister cards (6 tablets per blister card) NDC 59762-2198-7 NDC 59762-2198-3 500 mg (containing azithromycin dihydrate equivalent to 500 mg of azithromycin) Pink modified capsular shaped, engraved, film-coated Engraved with "G" on one side and "3070" on the other Bottles of 30 Boxes of 3 blister cards (3 tablets per blister card) NDC 59762-3070-2 NDC 59762-3070-1 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: 300 mg 59762-3110-1 600 mg 59762-3120-1 900 mg 59762-3130-1 1200 mg 59762-3140-1 [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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
GREENSTONE 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.
AZITHROMYCIN 250 MG AND 500 MG TABLETS, FOR ORAL USE
AZITHROMYCIN FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5)
11/2021
INDICATIONS AND USAGE
AZITHROMYCIN is a macrolide antibacterial drug indicated for mild to
moderate infections caused by
designated, susceptible bacteria:
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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)
DOSAGE AND ADMINISTRATION
•
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 bacterial sinusitis
500 mg once daily for 3 days.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
•
INFECTION
RECOMMENDED DOSE/DURATION OF THERAPY
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 (6 months of age and older)
(1.2)
Community-acquired pneumonia in adults and pediatric patients (6
months of age and older