What is the recommended dosage and treatment regimen for Paroxetine (selective serotonin reuptake inhibitor) in patients with major depressive disorder?

From the Guidelines

Paroxetine is typically started at 20 mg once daily for major depressive disorder, with dose increases by 10 mg increments at intervals of at least one week, up to a maximum of 50 mg daily, as recommended by the American College of Physicians 1. The treatment regimen should be individualized based on patient response and tolerance. Key considerations include:

• Starting dose: 20 mg once daily, usually taken in the morning
• Dose increments: 10 mg increments at intervals of at least one week
• Maximum dose: 50 mg daily
• Treatment duration: at least 6 months after symptom resolution to prevent relapse, and often for 9-12 months in total
• Potential side effects: nausea, drowsiness, dry mouth, insomnia, sexual dysfunction, and dizziness, which often improve after the first few weeks
• Discontinuation: taper dose gradually over several weeks to minimize withdrawal symptoms
• Administration: take consistently at the same time each day, with full therapeutic effects taking 2-4 weeks to develop It is essential to monitor patient status, therapeutic response, and adverse effects of antidepressant therapy on a regular basis, beginning within 1 to 2 weeks of initiation of therapy, as recommended by the American College of Physicians 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Major Depressive Disorder Usual Initial Dosage PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of PAXIL in the treatment of major depressive disorder As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. 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. Dose changes should occur at intervals of at least 1 week Maintenance Therapy There is no body of evidence available to answer the question of how long the patient treated with PAXIL should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of the efficacy of PAXIL has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg

The recommended dosage and treatment regimen for Paroxetine in patients with major depressive disorder is:

• Initial dose: 20 mg/day
• Dose range: 20 to 50 mg/day
• Dose increases: 10-mg/day increments, up to a maximum of 50 mg/day
• Dose change interval: at least 1 week
• Maintenance therapy: doses that averaged about 30 mg, for periods of up to 1 year 2 Key points:
• The full effect of Paroxetine may be delayed
• Acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy
• The dose needed to induce remission may not be identical to the dose needed to maintain and/or sustain euthymia

From the Research

Recommended Dosage and Treatment Regimen for Paroxetine

The recommended dosage and treatment regimen for Paroxetine in patients with major depressive disorder is as follows:

• The initial dose of paroxetine is typically 10 to 50 mg/day, with a maximum dose of 50 mg/day 3, 4.
• In 6- to 24-week well-designed trials, oral paroxetine 10 to 50 mg/day was significantly more effective than placebo, at least as effective as tricyclic antidepressants (TCAs) and as effective as other SSRIs and other antidepressants in the treatment of major depressive disorder 3, 4.
• Relapse or recurrence over 1 year after the initial response was significantly lower with paroxetine 10 to 50 mg/day than with placebo and similar to that with imipramine 50 to 275 mg/day 3, 4.

Efficacy in Different Patient Populations

• The efficacy of paroxetine 10 to 40 mg/day was similar to that of TCAs and fluoxetine 20 to 60 mg/day in 6- to 12-week trials in patients aged > or = 60 years with major depression 3, 4.
• Paroxetine 10 to 40 mg/day improved depressive symptoms to an extent similar to that of TCAs in patients with comorbid illness, and was more effective than placebo in the treatment of dysthymia and minor depression 3, 4.

Safety and Tolerability

• Paroxetine is generally well tolerated in adults, elderly individuals and patients with comorbid illness, with a tolerability profile similar to that of other SSRIs 3, 4, 5, 6.
• The most common adverse events with paroxetine were nausea, sexual dysfunction, somnolence, asthenia, headache, constipation, dizziness, sweating, tremor and decreased appetite 3, 4.