What is the recommended dose of paroxetine (Paxil)?

From the Guidelines

Paroxetine should be dosed at 20 mg daily for the treatment of premature ejaculation, as this dose has been shown to increase ejaculatory latency and provide the greatest benefit in remediating PE 1. The dosing of paroxetine can vary depending on the specific condition being treated, but for premature ejaculation, 20 mg daily is the recommended dose.

• The effective dose range for paroxetine in treating premature ejaculation is 10-40 mg/day, with the option of taking 20 mg 3-4 hours prior to intercourse 1.
• The majority of evidence supports the use of 20 mg daily dosing, as it provides the greatest benefit in increasing ejaculatory latency and improving patient satisfaction 1.
• It is essential to note that the optimal interval for situational dosing before intercourse has not been established, and the onset of action of paroxetine for this indication is unknown 1.
• However, the panel members' experience suggests that paroxetine usually returns upon discontinuing therapy, indicating that continuous therapy may be needed to maintain its benefits 1.
• Adverse event profiles of paroxetine in treating premature ejaculation are similar to those reported in patients being treated for depression, including nausea, dry mouth, drowsiness, and reduced libido 1.
• Doses effective in treating premature ejaculation are usually lower than those recommended for depression, suggesting that the frequency and severity of adverse events may also be less 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 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. Obsessive Compulsive Disorder Usual Initial Dosage PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of PAXIL in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10-mg/day increments. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of PAXIL in the treatment of OCD. The maximum dosage should not exceed 60 mg/day. Panic Disorder Usual Initial Dosage PAXIL should be administered as a single daily dose with or without food, usually in the morning. The target dose of PAXIL in the treatment of panic disorder is 40 mg/day Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of PAXIL. The maximum dosage should not exceed 60 mg/day. Social Anxiety Disorder Usual Initial Dosage PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day

The recommended initial dose of paroxetine is:

• 20 mg/day for Major Depressive Disorder and Social Anxiety Disorder
• 20 mg/day for Obsessive Compulsive Disorder, with a recommended dose of 40 mg daily
• 10 mg/day for Panic Disorder, with a target dose of 40 mg/day The maximum dosage should not exceed:
• 50 mg/day for Major Depressive Disorder
• 60 mg/day for Obsessive Compulsive Disorder and Panic Disorder Dose changes should occur at intervals of at least 1 week and in 10-mg/day increments 2

From the Research

Paroxetine Dose Information

• The starting dose of paroxetine is 20 mg/day, which is also the minimal effective dose 3.
• For most patients, 20 mg/day will be the optimal dose, but for those who do not show an adequate therapeutic response, the dose can be increased in 10-mg increments no more often than at weekly intervals to a maximum of 50 mg/day 3.
• The therapeutic dose range in the elderly is 20 mg to 40 mg of paroxetine 3.
• Other studies have shown that paroxetine can be effective at doses ranging from 10 to 50 mg/day for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder 4, 5, 6, 7.
• The controlled-release formulation of paroxetine (paroxetine CR) is approved for the treatment of major depression, social anxiety disorder, panic disorder, and premenstrual dysphoric disorder in adults, with a similar dose range to the immediate-release formulation 7.

Dose Adjustments and Special Considerations

• Dose adjustments may be necessary in patients with severe renal or hepatic impairment, as elimination of paroxetine is reduced in these populations 6.
• Paroxetine is generally well tolerated, but common adverse events include nausea, sexual dysfunction, somnolence, asthenia, headache, constipation, dizziness, sweating, tremor, and decreased appetite 4, 5, 6, 7.
• The potential for discontinuation syndrome and weight gain appears to be slightly higher with paroxetine than with other SSRIs 7.