RATIO AZITHROMYCIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Saatavilla:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

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:

2014-09-19

Valmisteyhteenveto

1
PRODUCT MONOGRAPH
Pr
ratio-AZITHROMYCIN
• Azithromycin 250 and 600 mg Tablets
(as Azithromycin monohydrate hemiethanolate)
Antibiotic
ratiopharm inc.
Date of Preparation:
17800 Lapointe
January 18, 2006
Mirabel PQ
J7J 1P3
Control #: 103432
- 2 -
PRODUCT MONOGRAPH
Pr
ratio-AZITHROMYCIN
• Azithromycin 250 and 600 mg Tablets
(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.
Adult Pharmacokinetics
- 3 -
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/mL)
T
max
(hr)
AUC
(µ
C
hr/mL)
T
½
(hr)
500 mg/250 mg tablet
500