Drug Detail:Paroxetine (Paroxetine [ pa-rox-a-teen ])
Drug Class: Selective serotonin reuptake inhibitors
Usual Adult Dose for Depression
Immediate-release (IR) tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 50 mg orally once a day
- Maximum dose: 50 mg/day
Controlled-release (CR) tablets:
- Initial dose: 25 mg orally once a day
- Maintenance dose: 25 to 62.5 mg orally once a day
- Maximum dose: 62.5 mg/day
Duration: Acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to 1 year.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
- Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg in IR formulations and 37.5 mg for the CR formulation.
- The efficacy of this drug in patients hospitalized with depression is unknown.
Use: Treatment of major depressive disorder (MDD)
Usual Adult Dose for Major Depressive Disorder
Immediate-release (IR) tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 50 mg orally once a day
- Maximum dose: 50 mg/day
Controlled-release (CR) tablets:
- Initial dose: 25 mg orally once a day
- Maintenance dose: 25 to 62.5 mg orally once a day
- Maximum dose: 62.5 mg/day
Duration: Acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to 1 year.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
- Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg in IR formulations and 37.5 mg for the CR formulation.
- The efficacy of this drug in patients hospitalized with depression is unknown.
Use: Treatment of major depressive disorder (MDD)
Usual Adult Dose for Social Anxiety Disorder
IR tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 60 mg orally once a day
- Maximum dose: 60 mg orally once a day
CR tablets:
- Initial dose: 12.5 mg orally once a day
- Maintenance dose: 12.5 to 37.5 mg orally once a day
- Maximum dose: 37.5 mg/day
Duration: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
Uses:
- Treatment of social anxiety disorder (SAD)
- Treatment of SAD/social phobia, characterized by marked and persistent fear of 1 or more social/performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others
Usual Adult Dose for Panic Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 60 mg/day
CR tablets:
- Initial dose: 12.5 mg orally once a day
- Maintenance dose: 12.5 to 75 mg orally once a day
- Maximum dose: 75 mg/day
Duration: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability
- The target dose in IR formulations is 40 mg once a day.
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
Uses:
- Treatment of panic disorder (PD)
- Treatment of PD with/without agoraphobia, indicated by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about having additional attacks, concern about the implications/consequences of the attacks and/or significant change in behavior related to the attacks
Usual Adult Dose for Premenstrual Dysphoric Disorder
CR tablets:
Continuous regimen:
- Initial dose: 12.5 mg orally once a day during the menstrual cycle
- Maintenance dose: 12.5 to 25 mg orally once a day during the menstrual cycle
- Maximum dose: 25 mg/day
Cyclic regimen:
- Initial dose: 12.5 mg orally once a day, starting 14 days prior to the anticipated start of menstruation through to the first full day of menses, and repeated with each new cycle
- Maintenance dose: 12.5 to 25 mg orally once a day
- Maximum dose: 25 mg/day
Duration: Efficacy has been demonstrated for up to 3 menstrual cycles; continuation of treatment beyond this time may be considered in responding patients
Comment: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
Use: Treatment of premenstrual dysphoric disorder (PMDD)
Usual Adult Dose for Obsessive Compulsive Disorder
IR tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 60 mg orally once a day
- Maximum dose: 60 mg/day
- Duration: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- The target dose is 40 mg/day.
Use: Treatment of compulsions and/or obsessions in patients with obsessive compulsive disorder (OCD) that are causing marked distress, significantly interfere with occupational/social functioning, or are time consuming
Usual Adult Dose for Post Traumatic Stress Disorder
IR tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 50 mg orally once a day
- Maximum dose: 50 mg/day
- Duration of Therapy:
- Generalized Anxiety Disorder (GAD): Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week treatment phase.
- Posttraumatic Stress Disorder (PTSD): Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
- Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
Usual Adult Dose for Generalized Anxiety Disorder
IR tablets and suspension:
- Initial dose: 20 mg orally once a day
- Maintenance dose: 20 to 50 mg orally once a day
- Maximum dose: 50 mg/day
- Duration of Therapy:
- Generalized Anxiety Disorder (GAD): Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week treatment phase.
- Posttraumatic Stress Disorder (PTSD): Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
- Episodes generally require several months or more of sustained pharmacological therapy; a periodic review of the need for ongoing maintenance treatment and appropriate dosing is recommended.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
Usual Adult Dose for Postmenopausal Symptoms
Mesylate:
- Capsules: 7.5 mg orally once a day
Comment: Safety and efficacy of mesylate capsules have not been established in the treatment of psychiatric conditions (e.g., depression, GAD, MDD, OCD, PTSD, SAD)
Use: Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause
Usual Geriatric Dose for Obsessive Compulsive Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
- Duration:
- GAD: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week acute treatment phase.
- OCD: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
- PTSD and SAD: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of compulsions and/or obsessions in patients with OCD that are causing marked distress, significantly interfere with occupational/social functioning, or are time consuming
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
- Treatment of SAD
- Treatment of SAD/social phobia, characterized by marked and persistent fear of 1 or more social/performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others
Usual Geriatric Dose for Post Traumatic Stress Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
- Duration:
- GAD: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week acute treatment phase.
- OCD: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
- PTSD and SAD: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of compulsions and/or obsessions in patients with OCD that are causing marked distress, significantly interfere with occupational/social functioning, or are time consuming
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
- Treatment of SAD
- Treatment of SAD/social phobia, characterized by marked and persistent fear of 1 or more social/performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others
Usual Geriatric Dose for Social Anxiety Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
- Duration:
- GAD: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week acute treatment phase.
- OCD: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
- PTSD and SAD: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of compulsions and/or obsessions in patients with OCD that are causing marked distress, significantly interfere with occupational/social functioning, or are time consuming
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
- Treatment of SAD
- Treatment of SAD/social phobia, characterized by marked and persistent fear of 1 or more social/performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others
Usual Geriatric Dose for Generalized Anxiety Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
- Duration:
- GAD: Efficacy has been demonstrated for up to 24 weeks in patients responding to treatment during an 8-week acute treatment phase.
- OCD: Efficacy has been demonstrated for up to 6 months; being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
- PTSD and SAD: Efficacy has been demonstrated for up to 12 weeks being a chronic condition, continuation of treatment beyond this time may be considered in responding patients.
Comments:
- The daily dose may be increased in 10 mg increments at weekly intervals according to clinical response and tolerability.
- This drug should not be used to treat mild, short-term anxiety, such as anxiety or tension associated with the stress of everyday life.
Uses:
- Treatment of GAD, characterized by apprehensive expectation/excessive anxiety and worry persisting for at least 6 months and in which the patient finds difficult to control
- Treatment of compulsions and/or obsessions in patients with OCD that are causing marked distress, significantly interfere with occupational/social functioning, or are time consuming
- Treatment of PTSD, which requires exposure to a traumatic event that involved actual/threatened death or serious injury, or threat to the physical integrity of self/others, and a response that involves intense fear, helplessness, or horror
- Treatment of SAD
- Treatment of SAD/social phobia, characterized by marked and persistent fear of 1 or more social/performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others
Usual Geriatric Dose for Depression
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
CR tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 50 mg orally once a day
Maximum dose: 50 mg/day
Duration:
- MDD: Acute episodes require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year.
- PD: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment may be considered in responding patients.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
- Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for IR formulations and 37.5 mg for the CR formulation.
Uses:
- Treatment of MDD
- Treatment of PD
- Treatment of PD with/without agoraphobia, indicated by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about having additional attacks, concern about the implications/consequences of the attacks and/or significant change in behavior related to the attacks
Usual Geriatric Dose for Panic Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
CR tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 50 mg orally once a day
Maximum dose: 50 mg/day
Duration:
- MDD: Acute episodes require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year.
- PD: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment may be considered in responding patients.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
- Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for IR formulations and 37.5 mg for the CR formulation.
Uses:
- Treatment of MDD
- Treatment of PD
- Treatment of PD with/without agoraphobia, indicated by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about having additional attacks, concern about the implications/consequences of the attacks and/or significant change in behavior related to the attacks
Usual Geriatric Dose for Major Depressive Disorder
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
CR tablets:
Initial dose: 12.5 mg orally once a day
Maintenance dose: 12.5 to 50 mg orally once a day
Maximum dose: 50 mg/day
Duration:
- MDD: Acute episodes require several months or longer of sustained pharmacologic therapy; systemic evaluation has shown that efficacy was maintained for up to one year.
- PD: Efficacy has been demonstrated for up to 12 weeks; being a chronic condition, continuation of treatment may be considered in responding patients.
Comments:
- IR formulations: The daily dose may be increased in 10 mg increments at weekly intervals, according to clinical response and tolerability.
- CR formulations: The daily dose may be increased in 12.5 mg increments at weekly intervals, according to clinical response and tolerability.
- Efficacy of up to one year was demonstrated with a daily dose averaging 30 mg for IR formulations and 37.5 mg for the CR formulation.
Uses:
- Treatment of MDD
- Treatment of PD
- Treatment of PD with/without agoraphobia, indicated by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about having additional attacks, concern about the implications/consequences of the attacks and/or significant change in behavior related to the attacks
Renal Dose Adjustments
Capsules: No adjustment recommended.
IR tablets and suspension:
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min):
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
CR tablets:
- Initial dose: 12.5 mg orally once a day
- Maintenance dose: 12.5 to 50 mg orally once a day
- Maximum dose:
- MDD or PD: 50 mg/day
- SAD: 37.5 mg/day
Liver Dose Adjustments
Capsules: No adjustment recommended.
MILD TO MODERATE LIVER DYSFUNCTION:
IR tablets and suspension: No adjustment recommended.
CR tablets: Data not available
SEVERE LIVER DYSFUNCTION:
IR tablets and suspension:
- Initial dose: 10 mg orally once a day
- Maintenance dose: 10 to 40 mg orally once a day
- Maximum dose: 40 mg/day
CR tablets:
- Initial dose: 12.5 mg orally once a day
- Maintenance dose: 12.5 to 50 mg orally once a day
- Maximum dose:
- MDD or PD: 50 mg/day
- SAD: 37.5 mg/day
Dose Adjustments
Dose adjustments should be made to maintain the patient on the lowest effective dose.
Concomitant use of drugs metabolized by CYP450 2D6:
- Doses at the lower end of the range should be considered when used concomitantly.
- Subsequent dosage adjustments should be made according to patient response and tolerability.
Switching between a MAOI and this drug: At least 14 days should elapse between ceasing one of these medicines and starting the other.
Treatment withdrawal:
- A gradual dose reduction is recommended instead of abrupt cessation where possible.
- If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active component or to any of the ingredients
- Starting this drug concurrently in a patient who is receiving MAOIs (e.g., IV methylene blue, linezolid)
- Use in combination with pimozide
- Use in combination with thioridazine
- Use of MAOIs used to treat psychiatric disorders OR within 14 days of stopping treatment with this drug
- Use of this drug within 14 days of stopping a MAOI to treat psychiatric disorders
US BOXED WARNINGS:
SUICIDAL THOUGHTS AND BEHAVIORS:
- Compared to placebo, antidepressants, including selective serotonin reuptake inhibitors (SSRIs), increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies of MDD and other psychiatric disorders.
- Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults older than 24 years of age; there was a reduction in the risk with antidepressants compared to placebo in adults 65 years and older.
- Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
- Patients of all ages who are started on antidepressant treatment should be monitored closely for worsening and emergence of suicidal thoughts and behaviors.
- Family members and caregivers should be advised of the need for close observation and communication with the prescriber.
- This drug is not approved for use in pediatric patients.
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- The dose may be taken with or without food, usually in the morning.
- Hydrochloride CR tablets: Swallow whole and do not chew or crush.
- Mesylate capsules: Administer at bedtime.
- Oral suspension: Shake bottle before drawing up the dose.
Storage requirements:
- Oral suspension: Store at or below 25 C (77 F).
General:
- The need for ongoing treatment should be regularly reviewed
- It is unknown whether the dose of antidepressant required to induce remission in major depressive disorder is the same as that needed to maintain and/or sustain euthymia
- Symptoms of premenstrual dysphoric disorder has been reported to worsen with age, until relieved at the onset of menopause
Monitoring:
- CARDIOVASCULAR: Regular blood pressure monitoring
- HEPATIC: Regular liver function tests
- METABOLIC: Signs/symptoms of hyponatremia
- NERVOUS SYSTEM: Signs/symptoms of serotonin syndrome
- PSYCHIATRIC: Discontinuation symptoms, worsening/emergence of suicidal thoughts, and/or unusual changes in mood/behavior
- RENAL: Regular renal function tests
Patient advice:
- Patients, families, and caregivers should report worsening of depression, suicidal ideation, or any unusual changes in behavior, especially during early antidepressant treatment and when doses are adjusted up or down.
- Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.
- Inform patients that this drug may cause dizziness and sedation, and they should avoid driving or operating machinery if these side effects occur.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Frequently asked questions
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