FIORINAL CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID

Pieejams no:

ARALEZ PHARMACEUTICALS CANADA INC

ATĶ kods:

N02BA71

SNN (starptautisko nepatentēto nosaukumu):

ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS

Deva:

50MG; 40MG; 330MG

Zāļu forma:

CAPSULE

Kompozīcija:

BUTALBITAL 50MG; CAFFEINE 40MG; ACETYLSALICYLIC ACID 330MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Schedule G (CDSA IV)

Ārstniecības joma:

BARBITURATES

Produktu pārskats:

Active ingredient group (AIG) number: 0301241001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-12-01

Produkta apraksts

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