TRIANAL CAPSULES

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID

Disponibil de la:

LABORATOIRE RIVA INC.

Codul ATC:

N02BA71

INN (nume internaţional):

ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS

Dozare:

50MG; 40MG; 330MG

Forma farmaceutică:

CAPSULE

Compoziție:

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

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Schedule G (CDSA IV)

Zonă Terapeutică:

SALICYLATES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-11-13

Caracteristicilor produsului

PRESCRIBING INFORMATION
TRIANAL TABLETS
Butalbital, Acetylsalicylic Acid and Caffeine
Tablets USP
TRIANAL CAPSULES
Butalbital, Acetylsalicylic Acid and Caffeine
Capsules USP
SEDATIVE ANALGESIC
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Canada
J7C 3V4
www.labriva.com
Date of Revision:
June 30, 2017
Control #: 201261
_ _
_Page 2 of 17_
PRESCRIBING INFORMATION
TRIANAL TABLETS
Butalbital, Acetylsalicylic Acid and Caffeine Tablets USP
TRIANAL CAPSULES
Butalbital, Acetylsalicylic Acid and Caffeine Capsules USP
THERAPEUTIC CLASSIFICATION
SEDATIVE ANALGESIC
ACTION AND CLINICAL PHARMACOLOGY
Pharmacologically, TRANAL TABLETS/TRIANAL CAPSULES
(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.
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 hou