AZITHROMYCIN powder, for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Epic Pharma, LLC

INN (mednarodno ime):

AZITHROMYCIN MONOHYDRATE

Sestava:

AZITHROMYCIN ANHYDROUS 100 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Azithromycin for oral suspension USP 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

Povzetek izdelek:

Azithromycin for oral suspension USP after constitution contains a banana-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) 42806-147-31 600 mg (15 mL bottle) 42806-149-32 900 mg (22.5 mL bottle) 42806-150-33 1200 mg (30 mL bottle) 42806-151-34 [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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
EPIC PHARMA, LLC
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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.
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5) 11/2021
INDICATIONS AND USAGE
Azithromycin for oral suspension USP 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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INFECTION
RECOMMENDED DOSE/DURATION OF THERAPY
Acute otitis media
(6 months of age and older)
30 mg/kg as a single dose or 10 mg/kg once daily for 3
days or 10 mg/kg as a single dose on Day 1 followed by 5
mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
(6 months of age and older)
10 mg/kg once daily for 3 days.
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) (1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of
age and older) (1.1, 1.2)
ADULT PATIENTS (2.1)
INFECTION
RECOMMENDED DOSE/DURATION
OF THERAPY
Community-ac