TEVA-TECNAL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

N02BA71

INN (nume internaţional):

ACETYLSALICYLIC ACID, COMB WITH PSYCHOLEPTICS

Dozare:

50MG; 40MG; 330MG

Forma farmaceutică:

TABLET

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:

2017-11-09

Caracteristicilor produsului

PRODUCT INFORMATION
TEVA-TECNAL
acetylsalicylic acid-butalbital-caffeine tablets
330 mg / 50 mg / 40 mg
USP
TEVA-TECNAL
acetylsalicylic acid-butalbital-caffeine capsules
330 mg / 50 mg / 40 mg
USP
Combination Analgesic
Teva Canada Limited
DATE OF REVISION:
30 Novopharm Court
January 22, 2024
Toronto, ON
Canada M1B 2K9
WWW.TEVACANADA.COM
Submission Control No: 278170
Page 2 of 22
PRODUCT INFORMATION
TEVA-TECNAL
acetylsalicylic acid-butalbital-caffeine tablets
USP
TEVA-TECNAL
acetylsalicylic acid-butalbital-caffeine capsules
USP
Combination Analgesic
ACTION AND CLINICAL PHARMACOLOGY
Pharmacologically, TEVA-TECNAL (ASA-butalbital-caffeine) 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
hours.
The elimination of therapeutic