AZITHROMYCIN tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Proficient Rx LP

ІПН (Міжнародна Ім'я):

AZITHROMYCIN ANHYDROUS

Склад:

AZITHROMYCIN ANHYDROUS 500 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 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 is 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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)] [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] Azithromycin should not be used in patients with pneumonia

Огляд продуктів:

Azithromycin tablets, USP are supplied in the following strengths and package configurations: Azithromycin tablets 250 mg are supplied as white film-coated oval shaped biconvex tablets debossed with W961 on one side and other side plain containing anhydrous azithromycin 250 mg. These are packaged as follows: Blister cards (3 tablets per blister card) NDC 63187-594-03 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

AZITHROMYCIN- AZITHROMYCIN TABLET, FILM COATED
PROFICIENT RX LP
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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
INDICATIONS AND USAGE
Azithromycin is a macrolide antibacterial drug indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
•
•
•
•
•
•
•
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Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are
judged to be inappropriate for oral therapy because
of moderate to severe illness or risk factors. (1.3)
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
SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to
18%), abdominal pain (3 to 7%), or vomiting (2 to
7%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WOCKHARDT USA LLC. AT
1-800-346-6854 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
1.1 Adult Patients
1.2 Pediatric Patients
1.3 Limitations of Use
2. DOSAGE AND ADMINISTRATION
2.1 Adult Patients
2.2 Pediatric Patients1
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Hepatic Dysfunction
5. WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Hepatotoxicity
5.3 QT Prolongation
5.4 Clostridium difficile-Associated Diarrhea (CDAD)
5.5 Exacerbation of myasthenia gravis
5.6 Use in Sexually Transmitted Infections
5.7 Development of Drug-Resistant Bac