PROPYL-THYRACIL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PROPYLTHIOURACIL

Disponible des:

PALADIN LABS INC.

Codi ATC:

H03BA02

Designació comuna internacional (DCI):

PROPYLTHIOURACIL

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

PROPYLTHIOURACIL 100MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANTITHYROID AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0103603002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2020-04-07

Fitxa tècnica

PRESCRIBING INFORMATION
Pr
PROPYL-THYRACIL
®
(propylthiouracil tablets USP)
Thyroid Inhibitor
Paladin Labs Inc.
Date of Revision:
100 Alexis-Nihon Blvd, Suite 600
April 6, 2020
Saint-Laurent, Quebec, Canada
H4M 2P2
Squire Pharmaceuticals Inc..
611
Control No.: 233767
2
PRESCRIBING INFORMATION
Pr
PROPYL-THYRACIL
®
(propylthiouracil tablets USP)
Thyroid Inhibitor
ACTION
Propylthiouracil affects the synthesis of thyroid hormones by
inhibiting the incorporation of
iodide into thyroglobulin. It does not inactivate thyroid hormones
previously formed or interfere
with their release from the gland.
Also, depending on the activity of the disease and on whether or not
the patient has previously
received iodide, the clinical effects will not appear until the stored
supply of thyroid hormones
has been utilized.
Clinical response may be delayed for up to two weeks. Propylthiouracil
may also decrease the
rate of conversion of T
4
(1-thyroxine) to T
3
(triiodothyronine) in peripheral tissues.
Iodide uptake is not decreased by propylthiouracil.
In responsive patients, prolonged remission may be obtained only after
several months of
treatment and may take up to several years. The average duration of
treatment is usually one
year.
Data suggest that stopping therapy as soon as the euthyroid state is
attained is as effective in
some patients as continuing therapy for a year or longer.
3
INDICATIONS
Propylthiouracil is indicated:
1.
For the medical management of hyperthyroidism.
2.
In conjunction with radioiodine to hasten recovery while awaiting the
effects of radiation.
3.
For control of thyrotoxicosis prior to surgery.
4.
In the management of a thyroid storm in addition to other therapeutic
measures.
CONTRAINDICATIONS
Hypersensitivity or idiosyncratic reaction to propylthiouracil.
Nursing mothers.
WARNINGS
SERIOUS WARNINGS AND PRECAUTIONS
Liver toxicity (see Hepatic Function section below)
HEPATIC FUNCTION: Liver injury resulting in liver failure, liver
transplantation, or death, has been
reported with propylthiouracil therapy i