AZITHROMYCIN- azithromycin monohydrate powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 100 mg in 5 mL

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 antibacteria

Product summary:

Azithromycin for oral suspension USP after constitution contains a cherry flavored suspension. Azithromycin for oral suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows: Azithromycin contents per bottle NDC 300 mg (15 mL bottle) 68788-9045-1 600 mg (15 mL bottle) 68788-9046-3 [See Dosage and Administration (2) ] for constitution instructions with each bottle type. 5 mL of constituted suspension of azithromycin for oral suspension USP, 100 mg/5 mL and 200 mg/5 mL, contains 6 mg of sodium. Storage: Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN- AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN FOR ORAL SUSPENSION.
AZITHROMYCIN FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity (5.1) 3/2017
Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis
(5.3) 2/2017
INDICATIONS AND USAGE
Azithromycin for oral suspension 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)
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. (1.4)
DOSAGE AND ADMINISTRATION
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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.
Genital ulcer disease (chancroid)
Non-gonococcal urethritis and cervicitis
One single 1 gram dose.
Gonococcal urethritis and cervicitis
One single 2 gram dose.
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INFE C TIO N
RECOMMENDED DOSE/DURATION OF THERAPY
Acute otitis media
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days