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 initiated at 20 mg once daily for major depressive disorder, with dose adjustments made at intervals of at least one week, and treatment should continue for at least 6 months after symptom resolution to prevent relapse, as recommended by the American College of Physicians 1. The effective dose range is generally 20-50 mg daily, with a maximum recommended dose of 50 mg per day. Most patients respond to 20 mg daily, though some may require higher doses for optimal effect. When discontinuing paroxetine, the dose should be tapered gradually over several weeks to minimize withdrawal symptoms. Patients should be monitored for side effects including nausea, sexual dysfunction, and increased suicidal thoughts, particularly in the first few weeks of treatment, as SSRIs are associated with an increased risk for suicide attempts compared with placebo 1. Paroxetine works by increasing serotonin levels in the brain by blocking its reuptake, which helps regulate mood. Full therapeutic effects may take 2-4 weeks to develop, so patients should be advised to continue treatment even if benefits aren't immediately apparent. Paroxetine should be taken consistently at the same time each day to maintain stable blood levels and optimize effectiveness. Key considerations in the management of major depressive disorder with paroxetine include:

• Regular assessment of patient status, therapeutic response, and adverse effects of antidepressant therapy beginning within 1 to 2 weeks of initiation of therapy 1
• Modification of treatment if the patient does not have an adequate response to pharmacotherapy within 6 to 8 weeks of the initiation of therapy for major depressive disorder 1
• Continuation of treatment for 4 to 9 months after a satisfactory response in patients with a first episode of major depressive disorder, with longer durations potentially beneficial for patients with multiple episodes of depression 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 significant efficacy demonstrated in 6- to 24-week well-designed trials 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.
• The efficacy of paroxetine 10 to 40 mg/day was similar to that of tricyclic antidepressants (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.

Treatment Considerations

Some key considerations for the treatment of major depressive disorder with paroxetine include:

• 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.
• The most common adverse events with paroxetine were nausea, sexual dysfunction, somnolence, asthenia, headache, constipation, dizziness, sweating, tremor, and decreased appetite 3, 4.
• Paroxetine is an important first-line option for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder, given the high degree of psychiatric comorbidity of depression and anxiety 3, 4.