Posology : מינונים

4.2    Posology and method of administration
Posology
It is recommended that Seroxat is administered once daily in the morning with food. The tablet should be swallowed whole.

Major depressive disorder
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from dose increases in 10 mg/day increments, up to a maximum of 50 mg/day according to the patient's response

As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 2 to 3 of weeks of initiation of therapy and thereafter as judged clinically appropriate.

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. This period may be several months.

Obsessive compulsive disorder
The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose can be increased weekly in 10 mg increments. Some patients will benefit from having their dose increased up to a maximum of 60 mg/day.
Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see section 5.1 Pharmacodynamic properties).

Panic disorder
The recommended dose is 40 mg daily. Patients should be started on 10 mg/day and the dose increased weekly in 10 mg steps according to the patient’s response. Some patients will benefit from having their dose increased up to a maximum of 60 mg/day.

A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder.

Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see section 5.1 Pharmacodynamic properties).

Social anxiety disorder/social phobia
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increases in 10 mg increments as required, up to a maximum of 50 mg/day according to the patient's response.

Generalised anxiety disorder
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increases in 10 mg increments as required, up to a maximum of 50 mg/day according to the patient's response

Post-traumatic stress disorder
The recommended dose is 20 mg daily. Some patients not responding to a 20 mg dose may benefit from having dose increases in 10 mg increments as required, up to a maximum of 50 mg/day according to the patient's response.


Discontinuation of paroxetine
As with other psychoactive medications, abrupt discontinuation should generally be avoided (see sections Warnings and Precautions & Adverse Reactions). The taper phase regimen used in recent clinical trials involved a decrease in the daily dose by 10 mg/day at weekly intervals.


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When a daily dose of 20 mg/day was reached, patients were continued on this dose for one week before treatment was stopped. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.


Children and adolescents (7-17 years) and Children aged below 7 years 
Paroxetine is not indicated and should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility.
The use of paroxetine has not been studied in children less than 7 years.


Elderly Population
Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Dosing should commence at the adult starting dose and may be increased up to 40 mg daily.


Renal/hepatic impairment
Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or in those with hepatic impairment. Therefore, dosage should be restricted to the lower end of the dosage range.

Method of administration

It is recommended that paroxetine is administered once daily in the morning with food.
The tablet should be swallowed rather than chewed.