AZITHROMYCIN tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sandoz Inc

INN (Nome Internazionale):

AZITHROMYCIN MONOHYDRATE

Composizione:

AZITHROMYCIN ANHYDROUS 600 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Azithromycin tablets are 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 tablets, 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 tablets, 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 tablets and other antibacterial drugs, azithromycin tabl

Dettagli prodotto:

Azithromycin tablets, USP, equivalent to 600 mg azithromycin, are unscored white, oval-shaped, film-coated tablets, debossed GG D7 on one side and plain on the reverse side, and are supplied as follows: NDC 0781-5793-31 in bottles of 30 tablets Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZITHROMYCIN TABLETS.
AZITHROMYCIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5) 07/2021
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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ADVERSE REACTIONS
The most common adverse reactions are diarrhea (5%), nausea (3%),
abdominal pain (3%), or vomiting,
(no percent given). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA
Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
Sexually Transmitted Diseases (2.1)
Mycobacterial Infections (2.2)
Azithromycin Tablets 600 mg (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