Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: SmithKline Beecham Limited, Great West Road, Brentford, Middlesex TW8 9GS. trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Treatment of:
The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.
As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient’s response.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually 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).
The recommended dose is 40 mg daily. Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose. 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. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.
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).
The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).
The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).
The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties).
Abrupt discontinuation should be avoided (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects). The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals. 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.
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. Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.
Paroxetine 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. In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects).
The use of paroxetine has not been studied in children less than 7 years. Paroxetine should not be used, as long as safety and efficacy in this age group have not been established.
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.
It is recommended that paroxetine is administered once daily in the morning with food.
The tablet should be swallowed rather than chewed.
Shake bottle before use.
A wide margin of safety is evident from available overdose information on paroxetine.
Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 “Undesirable effects”, fever and involuntary muscle contractions have been reported. Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone. Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol.
No specific antidote is known.
The treatment should consist of those general measures employed in the management of overdose with any antidepressant. Administration of 20-30 g activated charcoal may be considered if possible within a few hours after overdose intake to decrease absorption of paroxetine. Supportive care with frequent monitoring of vital signs and careful observation is indicated. Patient management should be as clinically indicated.
10/20/30 mg tablet: 3 years.
Oral suspension: 2 years (1 month after opening).
10/20/30 mg tablet: Do not store above 30°C.
Store in the original package in order to protect from light.
Oral suspension: Do not store above 25°C.
10 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper.
Pack sizes: 14 and 28 tablets.
Not all pack sizes may be marketed.
20 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper. Plastic containers (bottles) made of polypropylene, with polyethylene closures, may also be used.
Pack sizes: 50 × 1 tablet or 4, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 and 500 tablets.
Not all pack sizes may be marketed.
30 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper. Plastic containers (bottles) made of polypropylene, with polyethylene closures, may also be used.
Pack sizes: 28, 30, 56 and 60 tablets.
Not all pack sizes may be marketed.
Oral suspension: Amber glass bottle sealed with polypropylene child-resistant cap lined with a polyethylene wad.
A polypropylene measuring cup is included.
Pack size: 150 ml.
No special requirements.
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