AZITHROMYCIN tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Vivimed Labs Limited

INN (International Name):

AZITHROMYCIN ANHYDROUS

Sammensætning:

AZITHROMYCIN ANHYDROUS 600 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Azithromycin tablets, USP 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. Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablet, USP 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 tablet, USP 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 infections that are proven or strongly suspe

Produkt oversigt:

Azithromycin tablets USP, 600 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W962 on one side and other side plain containing anhydrous azithromycin 600 mg. These are packaged as follows: Bottles of 30: NDC 64679-962-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
VIVIMED LABS LIMITED
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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, Hypersensitivity (5.1) 3/2017
Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis
(5.3) 2/2017
INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin tablets and other
antibacterial drugs, azithromycin tablets should be used only to treat
or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
Mycobacterial Infections (2.2)
DOSAGE FORMS AND STRENGTHS
Azithromycin tablets 600 mg (3)
CONTRAINDICATIONS
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)
WARNINGS AND PRECAUTIONS
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 interval and cases of torsades de pointes have been
reported. This risk which can be fatal should be
considered in patients with certain cardiovascular disorder