Posology : מינונים

4.2    Posology and method of administration

Posology
Adults (including elderly)
The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg.

Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to re-evaluate the efficacy for the individual patient after 8 weeks of treatment.

In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of TOVIAZ should be 4 mg once daily (see section 4.5).

Special population

Renal and hepatic impairment
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2).

Moderate(3) or potent(4) CYP3A4 inhibitors
None               Moderate               Potent
Renal impairment (1)
Mild              4→8 mg   (2)
4 mg          Should be avoided
Moderate             4→8 mg(2)                4 mg           Contraindicated Severe                4 mg           Should be avoided     Contraindicated Hepatic impairment           Mild              4→8 mg(2)                4 mg          Should be avoided Moderate                4 mg           Should be avoided     Contraindicated (1)     Mild GFR = 50-80 ml/min; Moderate GFR = 30-50 ml/min; Severe GFR = <30 ml/min (2)     Cautious dose increase. See sections 4.4, 4.5 and 5.2
(3)     Moderate CYP3A4 inhibitors. See section 4.5
(4)     Potent CYP3A4 inhibitors. See sections 4.3, 4.4 and 4.5

TOVIAZ is contraindicated in subjects with severe hepatic impairment (see section 4.3).

Paediatric population
The safety and efficacy of TOVIAZ in children below 18 years of age have not yet been established. No data are available.

Method of administration
Tablets are to be taken once daily with liquid and swallowed whole. TOVIAZ can be administered with or without food.