AZITHROMYCIN MONOHYDRATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

LUPIN LIMITED

INN (International Adı):

AZITHROMYCIN MONOHYDRATE

Kompozisyon:

AZITHROMYCIN ANHYDROUS 600 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 tablets USP, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with ad

Ürün özeti:

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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

AZITHROMYCIN MONOHYDRATE- AZITHROMYCIN MONOHYDRATE TABLET
LUPIN LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN TABLETS
USP.
AZITHROMYCIN TABLETS USP, 600 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Azithromycin tablets USP 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
USP AND OTHER ANTIBACTERIAL DRUGS, AZITHROMYCIN TABLETS USP 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 USP, 600 mg
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)
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 de
pointes, those with prorrhythmic conditions, and with other drugs that
prolong the QT interval. (5.3)
_Clostridium difficile_ -associated diarrhea: Evaluate patients if
diarrhea occurs. (5.4)
Azithromycin exacerbate muscle weakness in persons with myasthenia
gravis (5.5)
ADVERSE REACTIONS
The most