Riik: Kanada
keel: inglise
Allikas: Health Canada
BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID
ARALEZ PHARMACEUTICALS CANADA INC
N02BA71
ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS
50MG; 40MG; 330MG
CAPSULE
BUTALBITAL 50MG; CAFFEINE 40MG; ACETYLSALICYLIC ACID 330MG
ORAL
100
Schedule G (CDSA IV)
BARBITURATES
Active ingredient group (AIG) number: 0301241001; AHFS:
APPROVED
2015-12-01
PRODUCT INFORMATION FIORINAL ® (acetylsalicylic acid-caffeine-butalbital) Capsules USP Combination Analgesic Aralez Pharmaceuticals Canada Inc.* DATE OF REVISION: 6733 Mississauga Rd., Suite 800 June 7, 2023 Mississauga, Ontario L5N 6J5 www.miravohealthcare.com Submission Control No: 270273 *Doing business as (d/b/a) Miravo Healthcare _ _ _ _ _Page 2 of 22_ PRODUCT INFORMATION NAME OF DRUG FIORINAL ® (acetylsalicylic acid-caffeine-butalbital) USP THERAPEUTIC CLASSIFICATION Combination Analgesic ACTION AND CLINICAL PHARMACOLOGY Pharmacologically, FIORINAL ® (ASA-caffeine-butalbital) combines the analgesic properties of acetylsalicylic acid (ASA) with the anxiolytic and muscle relaxant properties of butalbital. PHARMACOKINETICS: The behaviour of the individual components is described below. _ACETYLSALICYLIC ACID (ASA) _ ASA is a salicylate that binds to the cyclooxygenase enzyme leading to a reduction in prostaglandin activity. The systemic availability of ASA after an oral dose is highly dependent on the dosage form, the presence of food, the gastric emptying time, gastric pH, antacids, buffering agents, and particle size. These factors affect not necessarily the extent of absorption of total salicylates but more the stability of ASA prior to absorption. During the absorption process and after absorption, ASA is mainly hydrolyzed to salicylic acid and distributed to all body tissues and fluids, including fetal tissues, breast milk, and the central nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex, heart, and lung. In plasma, about 50% - 80% of the salicylic acid and its metabolites are loosely bound to plasma proteins. _ _ _ _ _Page 3 of 22_ The clearance of total salicylates is subject to saturable kinetics; however, first-order elimination kinetics are still a good approximation for doses up to 650 mg. The plasma half-life for ASA is about 12 minutes and for salicylic acid and/or total salicylates is about 3 hours. The elimination of therapeutic doses is through the kidneys Lugege kogu dokumenti