Страна: Канада
Език: английски
Източник: Health Canada
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)
PHARMEL INC
J01FA10
AZITHROMYCIN
200MG
POWDER FOR SUSPENSION
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 200MG
ORAL
15/22.5ML
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072003; AHFS:
CANCELLED POST MARKET
2006-08-17
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 Прочетете целия документ