AZITHROMYCIN DIHYDRATE- azithromycin tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Sẵn có từ:

REMEDYREPACK INC.

INN (Tên quốc tế):

AZITHROMYCIN DIHYDRATE

Thành phần:

AZITHROMYCIN ANHYDROUS 250 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these 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. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration ( 2)] .    - Acute bacterial exacerbations of chronic bronchitis due to  Haemophilus influenzae ,  Moraxella catarrhalis , or Streptococcus pneumoniae . - Acute bacterial sinusitis due to  Haemophilus influenzae ,  Moraxella catarrhalis  or  Streptococcus pneumoniae . - Community-acquired pne

Tóm tắt sản phẩm:

Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin.  Azithromycin Tablets, USP 250 mg are engraved “APO” on one side and “AZ250” on the other side. These are packaged in bottles and blister cards of 6 tablets as follows: Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin.  Azithromycin Tablets, USP 500 mg are engraved “APO” on one side and “AZ500” on the other. These are packaged in bottles and blister cards of 3 tablets as follows: Storage: Store at 20ºC to 25ºC (68ºF   to 77º   F); excursions permitted from 15ºC   to 30ºC (59ºF to 86º F) [See USP Controlled Room Temperature].  

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

AZITHROMYCIN DIHYDRATE- AZITHROMYCIN TABLET, FILM COATED
REMEDYREPACK INC.
----------
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 drug indicated for mild to
moderate infections caused by designated, susceptible
bacte ria:
Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1)
Acute bacterial sinusitis in adults ( 1.1)
Uncomplicated skin and skin structure infections in adults ( 1.1)
Urethritis and cervicitis in adults ( 1.1)
Genital ulcer disease in men ( 1.1)
Acute otitis media in pediatric patients ( 1.2)
Community-acquired pneumonia in adults and pediatric patients ( 1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients ( 1.1, 1.2)
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. ( 1.4)
DOSAGE AND ADMINISTRATION
ADULT PATIENTS ( 2.1)
INFE C TIO N
RECOMMENDED DOSE/DURATION OF THERAPY
Community-acquired
pneumonia
(mild
severity)
Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on
Days
2 through 5.
Acute
bacterial
exacerbations
of
chronic
bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once daily on
Days
2 through 5 or 50