AVA-AZITHROMYCIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Saatavilla:

AVANSTRA INC

ATC-koodi:

J01FA10

INN (Kansainvälinen yleisnimi):

AZITHROMYCIN

Annos:

250MG

Lääkemuoto:

TABLET

Koostumus:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG

Antoreitti:

ORAL

Kpl paketissa:

6/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

OTHER MACROLIDES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0126072001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-08-21

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
AVA-AZITHROMYCIN
Azithromycin Monohydrate Powder for Oral Suspension
100 mg/ 5 mL and 200 mg/ 5mL Azithromycin (as Azithromycin
Monohydrate)
PR
AVA-AZITHROMYCIN
Azithromycin Monohydrate Hemiethanolate Tablets
250 mg Azithromycin (as Azithromycin Monohydrate Hemiethanolate)
Antibiotic
Avanstra Inc. Date of Preparation: February 10, 2011
10761-25th NE, Suite 110, Building B,
Calgary, Alberta, Canada
T2C 3C2
Submission Control No: 144856
_ _
_Ava-Azithromycin Page 2 of 70 _
PR
AVA-AZITHROMYCIN
Azithromycin Monohydrate Powder for Oral Suspension
100 mg/ 5 mL and 200 mg/ 5mL Azithromycin (as Azithromycin
Monohydrate)
PR
AVA-AZITHROMYCIN
Azithromycin Monohydrate Hemiethanolate Tablets
250 mg Azithromycin (as Azithromycin Monohydrate Hemiethanolate)
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.
A
DULT
P
HARMACOKINETICS
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 do