FIORINAL CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID

Tilgjengelig fra:

ARALEZ PHARMACEUTICALS CANADA INC

ATC-kode:

N02BA71

INN (International Name):

ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS

Dosering :

50MG; 40MG; 330MG

Legemiddelform:

CAPSULE

Sammensetning:

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

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Schedule G (CDSA IV)

Terapeutisk område:

BARBITURATES

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-12-01

Preparatomtale

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