Gepirone Dosage

Usual Adult Dose for Major Depressive Disorder

INITIAL DOSE: 18.2 mg orally once a day

MAINTENANCE DOSE: Dosage titration should be based on clinical response and treatment tolerability.

MAXIMUM DOSE: 72.6 mg orally once a day

Comments:

Electrolyte abnormalities should be corrected before starting therapy with this drug.
Electrolytes should be monitored during dose titration and periodically during treatment in patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia.
An ECG should be performed prior to initiating therapy, during dosage titration, and periodically during treatment.
This treatment should not be started in patients with a QTc greater than 450 msec at baseline.
Dosage should not be escalated if the QTcF (QTc by Fridericia's formula) is greater than 450 msec.
It is recommended to assess patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with this drug.

Use: For the treatment of major depressive disorder

INITIAL DOSE: 18.2 mg orally once a day

MAINTENANCE DOSE: Dosage titration should be based on clinical response and treatment tolerability.

MAXIMUM DOSE: 36.3 mg orally once a day

Comments:

Electrolyte abnormalities should be corrected before starting therapy with this drug.
Electrolytes should be monitored during dose titration and periodically during treatment in patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia.
An ECG should be performed prior to initiating therapy, during dosage titration, and periodically during treatment.
This treatment should not be started in patients with a QTc greater than 450 msec at baseline.
Dosage should not be escalated if the QTcF (QTc by Fridericia's formula) is greater than 450 msec.
It is recommended to assess patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with this drug.

Use: For the treatment of major depressive disorder

CrCl 50 mL/min or greater: No dose adjustment recommended

CrCl less than 50 mL/min:

Initial dose (Day 1): 18.2 mg orally once a day
Maintenance dose: Dosage titration should be based on clinical response and treatment tolerability.
After Day 7: May be increased to 36.3 mg orally once a day
Maximum dose: 36.3 mg orally once a day

Mild liver dysfunction (Child-Pugh A): No dose adjustment recommended

Moderate liver dysfunction (Child-Pugh B):

Initial dose (Day 1): 18.2 mg orally once a day
Maintenance dose: Dosage titration should be based on clinical response and treatment tolerability.
After Day 7: May be increased to 36.3 mg orally once a day
Maximum dose: 36.3 mg orally once a day

Severe liver dysfunction (Child-Pugh C): Contraindicated

Dosage Modifications for Concomitant Use With CYP450 3A4 Inhibitors and Inducers:

Recommendations for Transitioning to or from a Monoamine Oxidase Inhibitor:

At least 14 days must elapse between MAOI antidepressant discontinuation and initiation of therapy with this drug.
Allow at least 14 days to elapse after discontinuing this drug prior to starting therapy with a MAOI antidepressant.

US BOXED WARNING:

SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. This drug is not approved for use in pediatric patients.

CONTRAINDICATIONS:

Known hypersensitivity to the active component or any of the ingredients
Prolonged QTc interval greater than 450 msec at baseline
Congenital long QT syndrome
Concomitant use of strong CYP450 34A inhibitors
Severe hepatic impairment
Taking, or within 14 days of stopping, a MAOI due to the risk of serious or possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome
Initiation of this drug in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Data not available

Administration advice:

Storage requirements:

Monitoring:

Cardiovascular: For elevated QT interval (at baseline, during titration, and periodically); monitor more frequently if this drug is used:
Concomitantly with drugs known to prolong the QT interval
In patients who develop a QTc of 450 msec or greater during treatment
In patients with a significant risk of developing torsade de pointes
Metabolic: For electrolyte abnormalities (at baseline and during treatment if indicated based on history or risk)

Psychiatric: For personal or family history of bipolar disorder, mania, or hypomania (at baseline)

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Take this drug with food at approximately the same time every day.
Seek medical attention if any symptoms of serotonin syndrome occur, especially with concomitant use of other antidepressants.
Notify your health care provider immediately at the emergence of suicidal ideation and behavior, especially during early treatment or during dose adjustments.
Report symptoms of feeling faint, loss of consciousness, or heart palpitations to your physician.
Inform your health care provider of current or future medication use, including over-the-counter medications.
Observe for signs of mania or hypomania activation and report any new symptoms to your provider.
Patients of childbearing potential: Notify your health care provider of a known/suspected pregnancy; a pregnancy registry is available.