AZITHROMYCIN- azithromycin tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals, Inc.

INN (mednarodno ime):

AZITHROMYCIN DIHYDRATE

Sestava:

AZITHROMYCIN ANHYDROUS 250 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Azithromycin is supplied in the following strengths and package configurations: Azithromycin 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin 250 mg tablets are engraved with "G" on one side and "3060" on the other. These are packaged in bottles and blister cards of 6 tablets as follows: Boxes of 3 blister cards (6 tablets per blister card) NDC 68788-9038-2 Azithromycin tablets should be stored between 15° to 30°C (59° to 86°F). [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:

New Drug Application Authorized Generic

Lastnosti izdelka

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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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 AND ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Hypersensitivity (5.1)
5/2017
Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis
(5.3)
4/2017
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
2.
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.
2.
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
or 10 mg/kg as a single dose on Day 1 followed by 5
mg/kg/day on Days 2 through 5.
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 di