Posology : מינונים

4.2      Posology and method of administration
Oral use.

Before initiating treatment with Anafranil, hypokalemia should be treated (see section 4.4 Warnings and precautions).

The dosage should be adapted to the individual patient's condition. The aim is to achieve an optimum effect while keeping the doses as low as possible and increasing them cautiously.

After a response has been obtained, maintenance therapy should be continued at the optimum dose to avoid relapse. Patients with a history of recurrent depression require maintenance treatment for a longer duration.
Duration of maintenance treatment and need for further treatment should be reviewed periodically.
As a precaution against possible QTc prolongation and serotonergic toxicity, adherence to the recommended doses of Anafranil is advised and any increase in dose should be made with caution if drugs that prolong QT interval or other serotonergic agents are co-administered (see sections 4.4 Warnings and precautions and 4.5 Interactions).

Abrupt discontinuation of Anafranil therapy should be avoided because of possible withdrawal symptoms.
Therefore, dosage should be stopped gradually after regular use for long duration and the patient should be monitored carefully when Anafranil therapy is discontinued.

Immediate release formulations (coated tablets) and slow-release tablets can be used inter- changeably in equivalent doses.

Adults

Depression and obsessive-compulsive syndromes
Start treatment with 50-75 mg/day (1 coated tablet of 25 mg 2-3 times daily or 1 slow-release tablet of 75 mg once daily [preferably in the evening]). Raise the daily dosage stepwise, e.g. 25 mg every few days, (depending on how the medication is tolerated) to 100-150 mg, during the first week of treatment. In severe cases, this dosage can be increased up to a maximum of 250 mg daily. Once there is a distinct improvement, adjust the daily dosage to a maintenance level of about 50-100 mg.

Dosage and administration in special populations

Geriatric population
Elderly patients generally show a stronger response to Anafranil than patients of intermediate age groups, Anafranil should be used with caution in elderly patients and doses should be increased cautiously. Start treatment with 10 mg daily. Gradually raise the dosage to an optimum level of 30-50 mg daily, which should be reached after about 10 days and then maintained until the end of treatment.


Children aged 5 years and older and adolescents (see also section 4.4) 
Adolescents generally show a stronger response to Anafranil than patients of intermediate age groups.
Anafranil should be used with caution in adolescents and doses should be increased cautiously.
Obsessive-compulsive syndromes

No experience is available in children under 5 years.
The starting dose is 25 mg daily and should be gradually increased (also given in divided doses) during the first 2 weeks, as tolerated, up to a daily maximum of 3 mg/kg or 100 mg, whichever is smaller. Thereafter, the dosage may be increased gradually over the next several weeks up to a daily maximum of 3 mg/kg or 200 mg, whichever is smaller.

Depression of varying origin
In children and adolescents, there is not sufficient evidence of safety and efficacy of Anafranil in the treatment of depressive states of varying aetiology and symptomatology. The use of Anafranil in children and adolescents (0-17 years of age) in this indication is therefore not recommended.

Renal impairment
Anafranil should be given with caution in patients with renal impairment (see section 4.4 Warnings and precautions).

Hepatic impairment
Anafranil should be given with caution in patients with hepatic impairment (see section 4.4Warnings and precautions).

Method of administration
The method of administration should be adapted to the individual patient's condition. The Divitabs (slow-release tablets divisible) can be halved, allowing the dosage to be adapted individually, but they should not be chewed.
Anafranil can be administered with or without food.