Paroxetine Dosage

Usual Adult Dose for Depression

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose:
Paroxetine- naive patients: 25 mg orally once a day with or without food, usually in the morning.
Conversion: 30 mg immediate release paroxetine corresponds to 37.5 mg extended release tablets.
Maintenance dose: The initial dose may be increased to a maximum of 62.5 mg per day.
Dosage change: Dose may be increased in 12.5 mg per day increments at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Anxiety

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: Doses up to 60 mg orally once a day with or without food, usually in the morning, can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg increments weekly, to a maximum of 37.5 mg per day.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Panic Disorder

Immediate release tablets and suspension:
Initial dose: 10 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once daily with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: May occur in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: Paroxetine- naive patients: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: The initial dose may be increased in 12.5 mg per day increments at intervals of at least one week, to a maximum of 75 mg per day.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Premenstrual Dysphoric Disorder

Extended release tablets:
Initial: 12.5 mg orally once a day with or without food, usually in the morning continuously, or alternatively, 12.5 mg orally once a day with or without food, usually in the morning during the luteal phase of the menstrual cycle (the 14 days prior to the anticipated start of menses).
Maintenance: Doses up to 25 mg once a day with or without food, usually in the morning, have been shown to be effective in clinical trials. Effectiveness for a period exceeding 3 menstrual cycles has not been evaluated in controlled trials. However, it is reasonable to consider continuation in a responding patient.
Dosage change: May occur at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Usual Adult Dose for Obsessive Compulsive Disorder

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 40 mg orally once a day with or without food, usually in the morning. Doses up to 60 mg orally once a day in the morning can be used.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Usual Adult Dose for Post Traumatic Stress Disorder

Immediate release tablets and suspension:
Initial dose: 20 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 20 to 50 mg orally once a day with or without food, usually in the morning.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Renal Dose Adjustments

CrCl 25 mL/min or less:
Immediate release tablets and suspension:
Initial dose: 10 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 10 mg to a maximum of 40 mg per day.
Dosage change: Dose may be increased in 10 mg per day increments at intervals of at least one week.

Extended release tablets:
Initial dose: Paroxetine- naive patients: 12.5 mg orally once a day with or without food, usually in the morning.
Maintenance dose: 12.5 mg to a maximum of 50 mg per day.
Dosage change: Dose may be increased in 12.5 mg per day increments at intervals of at least one week.
Caution: Extended release tablets should be swallowed whole and not chewed or crushed.

Liver Dose Adjustments

Immediate release tablets and suspension: Initially, 10 mg orally once a day with or without food, usually in the morning; dose may be increased in 10 mg/day increments at weekly intervals to a maximum of 40 mg per day.

Extended release tablets: Initially, 12.5 mg orally once a day with or without food, usually in the morning; dose may be increased in 12.5 mg/day increments at weekly intervals to a maximum of 50 mg per day.

Dose Adjustments

Dose changes in 10 mg per day increments should occur at intervals of at least 1 week. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Precautions

Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use, particularly during the first few months of treatment. Medical evidence has not shown this increased risk to exist in adults older than 24 years of age, but adults 65 years of age and older taking antidepressants appear to have a decreased risk of suicidality. The results of a meta-analysis indicate an overall favorable risk-to-benefit profile for the use of antidepressants (i.e., selective serotonin and/or norepinephrine reuptake inhibitors) in the treatment of pediatric patients (less than 19- years- old) with major depressive disorders (MDD), obsessive-compulsive disorder (OCD), or non- OCD anxiety disorders. Although this study also reports an overall increased risk of suicidal ideation/suicide attempt associated with the use of antidepressants in pediatric patients, the risk may be less than originally estimated. Additional prospective studies are warranted in order to confirm these findings.

Suicide related events have been reported in 3.7% of paroxetine treated children and adolescents in controlled clinical trials versus 2.5% reported in placebo- treated patients. In addition, the FDA reports antidepressant use may increase suicidal thoughts and actions in approximately 1 out of 50 pediatric patients (18 years or younger).

Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Symptoms associated with discontinuation of the immediate release product have been reported. Patients should be monitored for symptoms when discontinuing treatment with either form of paroxetine. A gradual reduction in dosage rather than an abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in dosage or discontinuation of treatment, then resuming the previous dose may be considered. Subsequently, a more gradual decrease in dosage may be attempted with careful monitoring of the patient.

At least 14 days should elapse between discontinuation of a MAOI and initiation of paroxetine therapy. At least 14 days should be allowed after stopping paroxetine before starting a MAOI.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Evaluation of the efficacy of paroxetine has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.

Patients should be maintained on the lowest effective dosage and periodically reassessed to determine the need for continued therapy.

Extended release tablets and immediate release tablets and suspension are usually administered in the morning without regard to food.

Extended release tablets should be swallowed whole and not chewed or crushed.

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