Apo-Paroxetine Dosage/Direction for Use

APO-PAROXETINE (paroxetine) is not indicated for use in children under 18 years of age (see POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM under WARNINGS).
GENERAL: APO-PAROXETINE (paroxetine) should be administered once daily in the morning and may be taken with food. The tablet should be swallowed rather than chewed.
Dose Adjustments: Based on pharmacokinetic parameters, steady-state paroxetine plasma levels are achieved over a 7 - 14 day interval. Hence, dosage adjustments in 10 mg increments should be made at 1 - 2 week intervals or according to clinician judgement.
Maintenance: During long term therapy for any indication, the dosage should be maintained at the lowest effective level.
Discontinuation of Treatment: Symptoms associated with the discontinuation of paroxetine have been reported in clinical trials and post marketing. Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which paroxetine is being prescribed. (See PRECAUTIONS and ADVERSE REACTIONS).
A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response. (See ADVERSE REACTIONS).
DEPRESSION: Usual Adult Dose: The administration of APO-PAROXETINE (paroxetine) should be initiated at 20 mg daily. For most patients, 20 mg daily will also be the optimum dose. The therapeutic response may be delayed until the third or fourth week of treatment.
Dose Range: For those patients who do not respond adequately to the 20 mg daily dose, a gradual increase in dosage up to 40 mg daily may be considered. The maximum recommended daily dose is 50 mg.
OBSESSIVE-COMPULSIVE DISORDER (OCD): Usual Adult Dose: The administration of APO-PAROXETINE (paroxetine) should be initiated at 20 mg/day. The recommended dose of APO-PAROXETINE in the treatment of OCD is 40 mg daily.
Dose Range: For those patients who do not respond adequately to the 40 mg daily dose, a gradual increase in dosage may be considered. The maximum recommended daily dose is 60 mg.
PANIC DISORDER: Usual Adult Dose: The recommended starting dose of APO-PAROXETINE (paroxetine) in the treatment of panic disorder is 10 mg/day. The recommended dose of APO-PAROXETINE in the treatment of panic disorder is 40 mg daily.
Dose Range: For those patients who do not respond adequately to the 40 mg daily dose, a gradual increase in dosage may be considered. The maximum recommended daily dose is 60 mg.
SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER): Usual Adult Dose: The recommended initial dosage is 20 mg/day. No clear dose-relationship has been demonstrated over a 20 to 60 mg/day dose range.
Dose Range: Some patients not responding adequately to a 20 mg dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
GENERALIZED ANXIETY DISORDER: Usual Adult Dose: The recommended initial dosage is 20 mg/day.
Dose Range: Some patients not responding adequately to a 20 mg dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
POST-TRAUMATIC STRESS DISORDER: Usual Adult Dose: The recommended starting dosage is 20 mg/day.
Dose Range: Some patients not responding adequately to a 20 mg/day dosage may benefit from gradual dosage increases, in 10 mg/day increments, up to a maximum of 50 mg/day.
SPECIAL PATIENT POPULATIONS: For any indication: Treatment of Pregnant Women During The Third Trimester: Post-marketing reports indicate that some neonates exposed to PAROXETINE, SSRIs, or other newer anti-depressants late in the third semester have developed complications requiring prolonged hospitalization, respiratory support, and tube-feeding (see PRECAUTIONS). When treating pregnant women with PAROXETINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering PAROXETINE in the third trimester.
Elderly: The recommended initial dose is 10 mg/day for elderly and/or debilitated patients. The dose may be increased if indicated up to a maximum of 40 mg daily.
Children: The use of APO-PAROXETINE in children under 18 years of age is not recommended as safety and efficacy have not been established in this population (see POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM under WARNINGS).
Renal/Hepatic Impairment: APO-PAROXETINE should be used with caution in patients with renal or hepatic impairment. The recommended initial dose is 10 mg/day in patients with clinically significant renal or hepatic impairment (see PRECAUTIONS). A maximum dose of 40 mg should not be exceeded.