Medicinal Products

BASDENE 25 mg

Generic drug of the therapeutic class: Endocrinology
active ingredients: Benzylthiouracil
laboratory: Bouchara-Recordati

Compressed
Box of 2 blister packs of 25
All forms

Indication

Hyperthyroidism.

Dosage BASDENE 25 mg Tablet Box of 2 blister packs of 25

The treatment will be initiated by a loading dose for about 1 to 2 months by clinically monitoring the patient. The doses will be lowered gradually, to reach in 3 or 4 months a maintenance dose which will be continued in general 18 months.

Adaptation of the treatment is essential because:

· Insufficient dosage: signs of hyperthyroidism reappear or worsen;

· For an excessive dosage: a hypothyroidism is established, characterized by the elevation of the TSH, an increase of the volume of the goitre.

Attack treatment : 150 to 200 mg (6-8 tablets) daily for a few weeks.

Maintenance treatment : as of clinical improvement and standardization of functional tests:

100 mg (4 tablets) daily for several months.

The administration is done in 3 taken regularly: spaced in the day, administered preferably at the time of the meals.

Another treatment regimen consists of:

· In a first phase: administration of the antithyroid drug at the dosage of the aforementioned etching treatment, until a biological hypothyroidism (obtained after about 6 weeks) is obtained;

· In a second phase: continuation of the antithyroid drug at the same dosage but by associating levothyroxine to obtain euthyroidism then progressive decrease of the antithyroid towards the 12 th month by pursuing the levothyroxine, the two products being stopped after 6 at 8 months.

Against indications

Thyroid cancer dependent TSH.

Pre-existing serious haematological disorders.

Side effects Basdene

· Any increase in the volume of goiter should, first, suggest hypothyroidism overdose.

· Leukopenia likely to be reported with fever, angina, infection, or even agranulocyloidosis or bone marrow failure with usually abrupt onset, requiring discontinuation of treatment and emergency blood counts.

· Allergic reactions: cutaneous, (pruritus, rash, urticaria) fever, erythema, arthralgia, myalgia, body aches also requiring discontinuation of treatment.

· As with other synthetic antithyroid drugs (especially propylthiouracil), very rare cases of ANCA-associated vasculitis have been reported, particularly with glomerulonephritis and need to be discontinued.

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