PHL-AZITHROMYCIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Предлага се от:

PHARMEL INC

АТС код:

J01FA10

INN (Международно Name):

AZITHROMYCIN

дозиране:

600MG

Лекарствена форма:

TABLET

Композиция:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 600MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

OTHER MACROLIDES

Каталог на резюме:

Active ingredient group (AIG) number: 0126072005; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2017-09-12

Данни за продукта

PRODUCT MONOGRAPH
PR
PHL-AZITHROMYCIN
Azithromycin Tablets, USP
250 mg and 600 mg
Azithromycin for Oral Suspension, House Standard
100 mg/5 mL and 200 mg/5 mL
ANTIBIOTIC
Pharmel Inc.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
April 25, 2013
Control number: 163972
_ _
PHL-AZITHROMYCIN_ Product Monograph _
_Page 2 of 77_
PR
PHL-AZITHROMYCIN
Azithromycin Tablets, USP
Azithromycin for Oral Suspension, House Standard
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Azithromycin, a macrolide antibiotic of the azalide subclass, exerts
its antibacterial action by
binding to the 50s ribosomal subunits of susceptible bacteria and
suppressing protein synthesis.
Following oral administration, azithromycin is rapidly absorbed (T
max
=2-3 hours) and distributed
widely throughout the body. Rapid movement of azithromycin from blood
into tissue results in
significantly higher azithromycin concentrations in tissue than in
plasma (up to 50 times the
maximum observed concentration in plasma). The absolute
bioavailability is approximately 37%.
When azithromycin suspension was administered with food to 28 adult
healthy male subjects, the
rate of absorption (C
max
) was increased by 56% while the extent of absorption (AUC) was
unchanged.
Food does not affect the absorption of azithromycin in the tablet
dosage form. Azithromycin
tablets and powder for oral suspension can be taken with or without
food.
ADULT PHARMACOKINETICS
Plasma concentrations of azithromycin decline in a polyphasic pattern,
resulting in an average
terminal half-life of 68 hours. The prolonged half-life is likely due
to extensive uptake and
subsequent release of drug from tissues. Over the dose range of 250 to
1000 mg orally, the serum
concentrations are related to dose. The long tissue half-life and
large volume of distribution
result from intracytoplasmic uptake and storage in lysosomal
phospholipid complexes.
In adults, the following pharmacokinetic data have been reported:
DOSE/DOSAGE FORM
SUBJECTS
C
MAX
(ΜG