Paroxetine Indications and Dosage
- anxiety
- depression
- hot flashes †
- menopause †
- obsessive-compulsive disorder (OCD)
- panic disorder
- posttraumatic stress disorder (PTSD)
- premature ejaculation †
- premenstrual dysphoric disorder (PMDD)
- social phobia (social anxiety disorder)
† non-FDA-approved indication
Paroxetine Indications and Dosage
For the treatment of major depression:
NOTE: Acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of antidepressant needed to induce remission is identical to the maintenance dose needed is unknown. The risk of suicide is inherent in any patient with depression, whether or not they are receiving an antidepressant. The clinician should be vigilant in assessing patients for suicidal ideation.
- for the treatment of major depression in adults:
Oral dosage (regular-release formulations):
Adults: Initially 20 mg PO once daily, usually in the morning. Increase as needed in increments of 10 mg, at weekly intervals, up to 50 mg/day. Systematic evaluation of the SSRIs have shown that antidepressant efficacy is maintained for up to 1 year of active treatment.
Elderly or debilitated patients: Initially 10 mg PO once daily. May increase as needed in increments of 10 mg, at weekly intervals, up to 40 mg/day.
Oral dosage (Paxil® CR™ controlled-release tablets):
Adults: Initially, 25 mg PO once daily, usually in the morning. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to 62.5 mg/day. Additionally, clinical trials have noted that lower dosages of 12.5 - 25 mg/day PO are effective.
Elderly or debilitated patients: Initially, 12.5 mg PO once daily. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to 50 mg/day.
- for the treatment of depression in pediatric patients † :
NOTE: The FDA has stated that paroxetine should not be used in children or adolescents with major depressive disorder. Reports have been made of increased suicidal thinking and suicide attempts in pediatric patients under the age of 18 treated with paroxetine for depression. Paroxetine is not currently approved for use in pediatric patients < 18 years of age. Other approved treatment options are available for depression in children. According to the FDA, there are 3 well-controlled trials that have shown paroxetine is no more effective than placebo for treatment of depression in pediatric patients, although other studies indicate efficacy.
Oral dosage (regular-release formulations):
Adolescents † : Safe and effective use has not been established; not recommended. In one trial, patients 12 - 19 years of age were treated with either paroxetine 20 - 40 mg/day PO, imipramine, or placebo. Significant improvement over placebo was seen in paroxetine-treated patients, but not imipramine-treated patients. The percentage of patients who withdrew from the study due to an adverse event was 32% in the imipramine group, compared to 10% and 7% in the paroxetine and placebo groups, respectively.
Children † >= 8 years: Safe and effective use has not been established; data are limited; not recommended. In an open-label study, children < 14 years of age were given an initial dose of 10 mg/day PO. The dosage was increased at weekly intervals, if necessary (mean maintenance dose, 16 mg/day plus or minus 5 mg). After a duration of treatment of 8.5 months, all children experienced remission of depressive symptoms. Adverse events were reported in 9.5% of patients; 36% of patients received a benzodiazepine for insomnia or acute anxieties.
For the treatment of anxiety disorders:
- for generalized anxiety disorder (GAD) or social phobia (social anxiety disorder):
NOTE: Anxiety is a chronic condition; consider continuation of drug in a responding patient. Maintain on the lowest effective dosage and periodically reassess to determine the need for continued treatment.
Oral dosage (regular-release formulations):
Adults: Initially, 10 mg PO once daily, usually in the morning. Doses should be increased by 10 mg/day at weekly intervals if needed and tolerated. The target dose is 40 mg PO once daily and maximum dose is 60 mg/day.
Elderly or debilitated patients: Initially, 10 mg PO once daily, usually in the morning. Doses should be increased by 10 mg/day at weekly intervals if needed and tolerated, up to 40 mg/day.
Oral dosage (Paxil® CR™ controlled-release tablets; FDA-approved for social anxiety disorder):
Adults: Initially, 12.5 mg PO once daily, usually in the morning. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to a maximum of 37.5 mg/day. The effective dosage ranged from 12.5 - 37.5 mg/day in clinical trials.
Elderly or debilitated patients: Initially, 12.5 mg PO once daily. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to 37.5 mg/day.
- for obsessive-compulsive disorder (OCD):
Oral dosage (regular-release formulations):
Adults: Initially 20 mg PO once daily, usually in the morning. May increase by 10 mg/day at weekly intervals if needed and tolerated. The target dose is 40 mg PO once daily, up to 60 mg/day.
Elderly or debilitated patients: Initially, 10 mg once daily. May increase by 10 mg/day at weekly intervals if needed and tolerated, up to 40 mg/day.
Adolescents † and children † >= 8 years : Data are limited in these age groups. An initial dose of 5 - 10 mg/day PO has been suggested. After titration, do not exceed 20 - 30 mg/day PO, depending on response and tolerance.
for panic disorder, with or without agoraphobia, including maintenance therapy:
NOTE: Panic disorder is a chronic condition; consider continuation of drug in a responding patient. Maintain on the lowest effective dosage and periodically reassess to determine the need for continued treatment.
Oral dosage (regular-release formulations):
Adults: Initially 10 mg PO once daily, usually in the morning. Doses should be increased by 10 mg/day at weekly intervals if needed and as tolerated. The target dose is 40 mg PO once daily, up to 60 mg/day.
Elderly or debilitated patients: Initially 10 mg PO once daily, usually in the morning. May increase by 10 mg/day at weekly intervals if needed and tolerated, up to 40 mg/day.
Oral dosage (Paxil® CR™ controlled-release tablets):
Adults: Initially, 12.5 mg PO once daily, usually in the morning. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to 75 mg/day. The effective dosage ranged from 12.5 - 75 mg/day in clinical trials.
Elderly or debilitated patients: Initially, 12.5 mg PO once daily. May increase as needed in increments of 12.5 mg, at a minimum of weekly intervals, up to 50 mg/day.
- for posttraumatic stress disorder (PTSD):
NOTE: PTSD is a chronic condition; consider continuation of drug in a responding patient. Maintain on the lowest effective dosage and periodically reassess to determine the need for continued treatment.
Oral dosage (regular-release formulations):
Adults: Initially, 20 mg PO once daily, usually in the morning. Doses should be increased by 10 mg/day at weekly intervals if needed and tolerated. The target dose is 40 mg PO once daily and maximum dose is 60 mg/day. Safety and efficacy were demonstrated in 3 clinical trials involving nearly 1200 patients aged 18 - 78 years with PTSD due to various stressors. Patients experienced up to a 50% reduction in PTSD symptom severity; 75% reported significant improvement. The drug was effective in relieving all three symptom clusters (i.e., flashbacks; avoidance/emotional numbing; and hyperarousal - e.g., insomnia, irritability and problems concentrating).
Elderly or debilitated patients: Initially, 10 mg PO once daily, usually in the morning. Doses should be increased by 10 mg/day at weekly intervals if needed and tolerated, up to 40 mg/day.
For the treatment of premature ejaculation † :
Oral dosage (regular-release formulations):
Adult males: Sixty men with lifelong rapid ejaculation (i.e., an intravaginal ejaculation latency time of <= 1 minute) were randomly assigned to receive paroxetine 20 mg/day PO, another SSRI, or placebo for 6 weeks. Compared with the placebo group, which had a mean intravaginal ejaculation latency time (IELT) of 20 seconds, patients treated with paroxetine had an increase in IELT to about 110 seconds. In one study of men with lifelong rapid ejaculation (IELT <= 1 minute), paroxetine 20 mg/day PO increased mean IELT by 480% (from a mean of 83 seconds to a mean of 602 seconds).
For the treatment of premenstrual dysphoric disorder (PMDD) according to the criteria of the DSM-IV:
Oral dosage (regular-release formulations † ):
Adult females: Dosages have ranged from 5 - 30 mg/day PO, dependent on clinical response and tolerance. Continuous daily dosing or, alternatively, luteal phase administration during the 7 - 14 days prior to menses, has been effective.
Oral dosage (Paxil® CR™ controlled-release tablets):
Adult females: 12.5 mg PO once daily, usually in the morning. Doses of 25 mg/day PO have been shown to have similar efficacy to 12.5 mg/day. If dosage increases are indicated, increase not more than once every 7 days, up to a maximum of 37.5 mg/day PO. Continuous daily dosing or, alternatively, luteal phase administration during the 14 days prior to menses, has been effective.
For the treatment of hot flashes † in women with breast cancer experiencing symptoms of menopause † :
Oral dosage (regular-release formulations):
Adult females: Preliminary pilot study in 30 women have reported that paroxetine 10 - 20 mg/day PO reduces the incidence of hot flashes by a mean of 67% in women with breast cancer who are taking tamoxifen or who are experiencing menopause. Most women (75%) noted a reduction in hot flash severity; many also noted that hot flashes returned upon DC of paroxetine. Twenty-seven women completed the six-week study period. A statistically significant improvement in depression, sleep, anxiety, and quality of life was noted; 83% of the study participants chose to continue paroxetine therapy at the end of study. Further studies are needed.
Maximum Dosage Limits:
- Adults: 50 - 60 mg/day PO for regular-release dosage forms, dependent on indication. 62.5 - 75 mg/day PO for Paxil® CR™, dependent on indication. The maximum dosage for PMDD or social anxiety disorder (Paxil® CR™) is 37.5 mg/day PO.
- Elderly: 40 mg/day PO for regular-release dosage forms; 50 mg/day PO for Paxil® CR™. The maximum dosage for PMDD or social anxiety (Paxil® CR™) is 37.5 mg/day PO.
- Adolescents: 20 - 40 mg/day PO has been suggested; data are limited. Do not use controlled-release tablets. The FDA does not currently recommend use.
- Children >= 8 years: 20 - 30 mg/day PO has been suggested; data are limited. Do not use controlled-release tablets. The FDA does not currently recommend use.
- Children < 8 years: Safe and effective use has not been established.
Patients with hepatic impairment:
Non-extended release dosage forms: The initial recommended dose is 10 mg/day PO. Increases may be made if clinically indicated. Dosage should not exceed 40 mg/day PO. Controlled-release tablets: The initial recommended dose is 12.5 mg/day PO. Increases may be made if clinically indicated, but dosage should not exceed 50 mg/day PO, regardless of indication.
Patients with renal impairment:
CrCl 30 - 60 ml/min: Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available. Lower doses may be needed.
CrCl < 30 ml/min: Non-extended release dosage forms: The initial recommended dose is 10 mg/day PO. Increases may be made if clinically indicated. Dosage should not exceed 40 mg/day PO. Controlled-release tablets: The initial recommended dose is 12.5 mg/day PO. Increases may be made if clinically indicated, but dosage should not exceed 50 mg/day PO, regardless of indication.
Intermittent hemodialysis:
See dosage for patients with CrCl < 30 ml/min. Paroxetine is unlikely to be significantly removed by hemodialysis given its large volume of distribution.
† non-FDA approved indication
[ Last revised: 7/2/2004 6:09:00 PM ]
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