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 600 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. Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis. Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)]. Treatment of Disseminated MAC Disease Azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)]. 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 infection

Product summary:

Azithromycin 600 mg tablets (engraved on front with "G" and on back with "3080") are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets. Azithromycin tablets are supplied as follows: Bottles of 30 NDC 59762-3080-1 Tablets should be stored at or below 30°C (86°F). Azithromycin for oral suspension is supplied in single- dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows: Boxes of 10 single- dose packets (1 g) NDC 59762-3051-1 Boxes of 3 single- dose packets (1 g) NDC 59762-3051-2 Store single- dose packets below 30°C (86°F).

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 600 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 indicated for mild to
moderate infections caused by
designated, susceptible bacteria:
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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
or prevent infections that are proven
or strongly suspected to be caused by susceptible bacteria. (1.3)
DOSAGE AND ADMINISTRATION
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•
DOSAGE FORMS AND STRENGTHS
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•
CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
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•
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•
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Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
Sexually Transmitted Diseases (2.1)
Mycobacterial Infections (2.2)
Azithromycin 600 mg tablets (3)
Azithromycin for oral suspension 1000 mg/5 mL (3)
Patients with known hypersensitivity to azithromycin, erythromycin,
any macrolide, or ketolide
antibiotic. (4.1)
Patients with a history of cholestatic jaundice/hepatic dysfunction
associated with prior use of
azithromycin. (4.2)
Serious (including fatal) allergic and skin reactions. Discontinue
Azithromycin and initiate appropriate
therapy if reaction occurs. (5.1)
Hepatotoxicity: Discontinue azithromycin immediately if signs and
symptoms of hepatitis occur. (5.2)
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of
azithromycin in neonates
(treatment up to 42 days of life), IHPS has been reported. Direct
parents and caregivers to contact
their physician if vomiting or irritability with feeding occurs. (5.3)
Prolongation of QT