AZITHROMYCIN tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

REMEDYREPACK INC.

INN (Nama Internasional):

AZITHROMYCIN MONOHYDRATE

Komposisi:

AZITHROMYCIN ANHYDROUS 600 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease Azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, are 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, are 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 an

Ringkasan produk:

Azithromycin Tablets USP, 600 mg are supplied as white, capsule shaped, unscored, biconvex film-coated tablets, debossed with “789” on one side and “PLIVA” on the other, containing azithromycin monohydrate equivalent to 600 mg of azithromycin, USP, available in NDC: 70518-0713-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
REMEDYREPACK 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) 10/2021
INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial indicated for mild
to moderate infections caused by
designated, susceptible bacteria:
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. ( 1.3)
DOSAGE AND ADMINISTRATION
Mycobacterial Infections ( 2.2)
DOSAGE FORMS AND STRENGTHS
Azithromycin 600 mg tablets ( 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
disorders including known QT
prolongation or history torsades