THYROZOL

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

THIAMAZOLE

Disponible depuis:

MERCK TBK - Indonesia

DCI (Dénomination commune internationale):

THIAMAZOLE

Dosage:

5 Mg

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

Fabriqué par:

MERCK KGAA - Federal Republic of Germany

Date de l'autorisation:

2019-11-15

Résumé des caractéristiques du produit

_Page 1 of 9 _
THYROZOL®
THIAMAZOLE
ANTITHYROID
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Thyrozol 5 mg film-coated tablet contains 5 mg Thiamazole.
Each Thyrozol 10 mg film-coated tablet contains 10 mg Thiamazole.
Excipient(s):
Contains 200 mg Lactose monohydrate per tablet (Thyrozol 5 mg), see
section 3.4 Special Warnings and
Special Precautions for Use.
Contains 195 mg Lactose monohydrate per tablet (Thyrozol 10 mg), see
section 3.4 Special Warnings and
Special Precautions for Use.
For a full list of excipients, see section 5.1 List of Excipient.
2.
PHARMACEUTICAL FORM
Film-coated tablet.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS

Drug treatment of hyperthyroidism, especially in slight or absent
thyroid enlargement (goitre) as well as
in younger patients.

Preparation for surgery in all forms of hyperthyroidism.

Preparation of patients with hyperthyroidism for planned radioiodine
treatment to prevent the risk of a
thyrotoxic crisis after therapy.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
CONSERVATIVE TREATMENT OF HYPERTHYROIDISM
Two different dosage regimens are recommended:
a)
Complete blocking of thyroid hormone production is achieved with daily
doses of 25 to at the most 40
mg Thiamazole.
Initial therapy (to achieve normal metabolic activity of the thyroid
gland):
Maximum daily dose: 40 mg Thiamazole in single doses of maximally 20
mg Thiamazole, depending
on the severity of the disease.
2 times 1 tablet Thyrozol 10 mg (20 mg) - mild cases
2 times 1 tablet Thyrozol 20 mg (40 mg) - severe cases.
After normalization of the thyroid function (generally between weeks 3
and 8) the dose is stepwise
reduced in long-term treatment to a maintenance dose of 5 to 20 mg
daily. This dosage usually requires
the additional administration of thyroid hormones.
b)
In therapy with Thyrozol alone the dose depends on metabolic activity
which must be checked
individually in each patient, paying particular attention to the TSH
(= Thyroid Stimulating Hormone)
DISETUJUI OLEH BPOM: 31/12/2021
EREG100149VR12100180
EREG