Usual Adult Dose for Depression

Initial dose: 20 mg to 30 mg orally 2 times a day
Maintenance dose: 60 mg per day, given either once a day OR 30 mg orally 2 times a day
Maximum dose: 120 mg/day

Comments:

• Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day
• Data are lacking to show that doses greater than 60 mg per day confer any additional benefits.
• Acute 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.

Use: Treatment of major depressive disorder (MDD)

Usual Adult Dose for Fibromyalgia

Initial dose: 30 mg orally once a day for at least 1 week
Maintenance dose: 30 to 60 mg orally once a day

Comments:

• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response.

Use: Treatment of fibromyalgia

Usual Adult Dose for Generalized Anxiety Disorder

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 120 mg orally once a day
Maximum dose: 120 mg/day

Comments:

• Some patients may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• The dose may be increased in increments of 30 mg once a day if clinically appropriate.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• 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.

Use: Treatment of generalized anxiety disorder (GAD)

Usual Adult Dose for Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Adult Dose for Neuropathic Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Adult Dose for Chronic Pain

Initial dose: 30 to 60 mg orally once a day
Maintenance dose: 60 mg orally once a day

Comments:

• Some patients for whom tolerability may be a concern may require 30 mg orally once day for 1 week, before increasing the dose to 60 mg per day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy beyond 12 weeks in the treatment of diabetic peripheral neuropathy has not been established; effectiveness should be based on individual patient response.
• Efficacy in the treatment of chronic musculoskeletal pain beyond 13 weeks has not been established.

Uses:

• Treatment of chronic musculoskeletal pain
• Treatment of diabetic peripheral neuropathic pain

Usual Geriatric Dose for Generalized Anxiety Disorder

Initial dose: 30 mg orally once a day for at least 2 weeks
Maintenance dose: 60 mg orally once a day
Maximum dose: 120 mg/day

Comments:

• An increase to 60 mg orally once a day may be considered after 2 weeks with an initial dose.
• If the dose is increased beyond 60 mg, it should be done in increments of 30 mg once a day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• 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.

Use: Treatment of GAD

Usual Pediatric Dose for Generalized Anxiety Disorder

7 to 17 years:

• Initial dose: 30 mg orally once a day for at least 2 weeks
• Maintenance dose: 30 to 60 mg orally once a day
• Maximum dose: 120 mg/day

Comments:

• An increase to 60 mg orally once a day may be considered after 2 weeks with an initial dose.
• If the daily dose is increased beyond 60 mg, it should be done in increments of 30 mg once a day.
• There is no evidence that doses greater than 60 mg per day confer additional benefit.
• 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.

Use: Treatment of GAD

Usual Pediatric Dose for Fibromyalgia

13 years and older:

• Initial dose: 30 mg orally once a day for at least 1 week
• Maintenance dose: 30 to 60 mg orally once a day

Comments:

• There is no evidence that doses greater than 60 mg per day confer additional benefit; higher doses are associated with a higher rate of side effects.
• Efficacy has been demonstrated for up to 3 months in placebo-controlled studies; effectiveness beyond this has not been demonstrated in longer studies; therefore, continued treatment should be based on individual patient response.

Use: Treatment of fibromyalgia

Renal Dose Adjustments

Mild to moderate renal dysfunction (glomerular filtration rate [GFR] 30 mL/min and greater OR CrCl 30 mL/min and greater): Data not available
Severe renal dysfunction (GFR less than 30 mL/min OR CrCl 15 to less than 30 mL/min): Not recommended.

Liver Dose Adjustments

Mild to severe liver dysfunction (Child-Pugh A to C): Not recommended.
Chronic liver dysfunction or cirrhosis: Not recommended.

Jaundice of clinically significant liver dysfunction during treatment: Treatment should be discontinued, and should not be resumed unless other causes can be established.

Dose Adjustments

Treatment withdrawal:

• Tapering of the dose is recommended for therapy lasting over 1 week.
• The dose should be gradually reduced over at least 2 weeks
• If intolerable symptoms occur, it is recommended to consider resuming the previously prescribed dose and to decrease the dose at a more gradual rate.

Switching from this drug to a MAO inhibitor (MAOI) MAOI intended to treat psychiatric disorders: At least 5 days should elapse after stopping this drug and starting a MAOI.

Switching from a MAOI intended to treat of psychiatric disorders to this drug: At least 14 days should elapse after stopping a MAOI and starting this drug.

Patients who require urgent treatment with linezolid/IV methylene blue during treatment:

• The potential benefits must outweigh the risks of serotonin syndrome.
• This drug should be stopped promptly before administering linezolid/IV methylene blue.
• Patients should be monitored for serotonin syndrome for 5 days OR 24 hours after the last dose of linezolid/IV methylene blue, whichever comes first.
• Treatment may resume 24 hours after the last dose of linezolid/IV methylene blue.

Patients with substantial alcohol use: Use is not recommended

Precautions

CONTRAINDICATIONS:

• Starting treatment with this drug in patients who are being treated with MAOIs (e.g., linezolid, IV methylene blue)
• Use of MAOIs intended to treat psychiatric disorders with this drug or within 5 days of stropping treatment with this drug
• Use of this drug within 14 days of stopping a MAOI intended to treat psychiatric disorders

US BOXED WARNINGS:
SUICIDAL THOUGHTS AND BEHAVIORS:

• Antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents, (e.g., pediatric patients) and young adults in short-term studies.
• These studies did not show an increased risk of suicidal thoughts and behaviors with antidepressant use in patients over 24 years of age; there was a reduction in risk with antidepressant use in patients 65 years and older.

Recommendations:

• The emergence of suicidal thoughts and behaviors and clinical worsening of symptoms should be monitored closely in patients of all ages who are started on antidepressant therapy.
• The need for close observation and communication with the patient's healthcare provider should be discussed with families and caregivers.

Safety and efficacy in the treatment of GAD have not been established in patients younger than 7 years; this drug is not recommended for use in these patients.
Safety and efficacy in the treatment of fibromyalgia have not been established in patients younger than 13 years; this drug is not recommended for use in these patients.
Safety and efficacy in the treatment of chronic musculoskeletal pain, diabetic peripheral neuropathy, and/or MDD have not been established in children; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Severe renal dysfunction on hemodialysis: Not recommended.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Doses may be taken without regard to meals.
• Swallow doses whole; do not chew or crush the capsules.
• Alternative administration (e.g., sprinkled on applesauce, given via nasogastric tube): The manufacturer product information should be consulted.

General:

• There are no data regarding the effect of gastric motility alterations in the stability of the enteric coating of oral formulations.
• This drug may affect urethral resistance.
• Limitation of use: Animal models demonstrated efficacy in treating inflammatory, neuropathic, and/or persistent pain; however, analgesic activity was not demonstrated for acute and/or arthritic pain.

Monitoring:

• CARDIOVASCULAR: Regular blood pressure monitoring
• HEPATIC: Regular liver function tests
• 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 be instructed to avoid alcohol use while taking this medicine, as this combination may be associated with severe liver injury.
• Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
• Patients should avoid overheating and dehydration.
• 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.

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