Usual Adult Dose for Fibromyalgia

Maintenance dose: 50 mg orally 2 times a day
Maximum dose: 100 mg orally 2 times a day (200 mg orally per day)

Comments:

• Dosing may be titrated according to the following schedule:
• Initial dose on day 1: 12.5 mg orally once
• Days 2 and 3: 12.5 mg orally 2 times a day
• Days 4 through 7: 25 mg orally 2 times a day
• After day 7: 50 mg orally 2 times a day

Renal Dose Adjustments

• Mild renal impairment (CrCl 50 to 80 mL/min): No adjustment recommended
• Moderate renal impairment (CrCl 30 to 49 mL/min): Use with caution
• Severe renal impairment (CrCl 5 to 29 mL/min): 25 mg orally twice a day (maintenance dose). Based on individual patient response, the dose may be increased to 50 mg twice a day
• End-stage renal disease: Not recommended

Liver Dose Adjustments

• Mild to moderate hepatic impairment: No adjustment recommended
• Severe hepatic impairment: Use with caution

Precautions

US BOXED WARNINGS:

• SUICIDALITY AND ANTIDEPRESSANT DRUGS:
• This drug is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. There was a reduction in risk with antidepressants compared to placebo in adults aged 65 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 this drug should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
• This drug is not approved for use in the treatment of major depressive disorder.
• This drug is not approved for use in pediatric patient.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be taken without regard to meals; however, in some patients, food improves the tolerability of the drug.
• This drug should be tapered over a period of at least 2 weeks and not abruptly discontinued after extended use.

• Doses above 200 mg/day have not been studied.
• Patients should be reassessed after 12 weeks for efficacy. If patients have little to no benefit, treatment discontinuation should be considered.

• Psychiatric: Patients should be monitored for discontinuation symptoms, and for worsening and emergence of suicidal thoughts.
• Neurologic: Patients should be monitored for symptoms of serotonin syndrome.
• Cardiovascular: Patients should have regular monitoring of blood pressure.

• This drug may impair judgment, thinking, and motor skills. Driving or operating machinery should be avoided if patient is affected.
• Patients should be instructed to avoid abrupt discontinuation of treatment.
• Patients and caregivers should be told to report any new or worsening depression.