FIORINAL CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID

Disponível em:

ARALEZ PHARMACEUTICALS CANADA INC

Código ATC:

N02BA71

DCI (Denominação Comum Internacional):

ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS

Dosagem:

50MG; 40MG; 330MG

Forma farmacêutica:

CAPSULE

Composição:

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

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Schedule G (CDSA IV)

Área terapêutica:

BARBITURATES

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2015-12-01

Características técnicas

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
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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.
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_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