AZITHROMYCIN MONOHYDRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

AZITHROMYCIN MONOHYDRATE

Composition:

AZITHROMYCIN ANHYDROUS 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strong

Product summary:

Azithromycin Tablets USP, 600 mg are supplied as white, oval shaped film-coated tablets, engraved with "LU" on one side and "L13" on the other side containing azithromycin monohydrate USP equivalent to 600 mg of azithromycin USP. These are packaged in bottles of 30 tablets as follows: Bottles of 30 Tablets:   NDC 68180-162-06 Tablets should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZITHROMYCIN MONOHYDRATE - AZITHROMYCIN MONOHYDRATE TABLET
LUPIN PHARMACEUTICALS, 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, 600 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5) 11/2021
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 tablets USP, 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
disorders including known QT
prolong