Duloxetine Dose Increase Protocol
For patients currently taking duloxetine 30 mg daily, the next appropriate dose increase is to 60 mg daily. 1, 2
Dosing Guidelines for Duloxetine
- The FDA-approved dosing for duloxetine indicates that after starting at 30 mg daily for 1 week, the next step is to increase to 60 mg daily 1
- For most conditions including major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia, 60 mg daily is the standard therapeutic dose 1
- When initiating treatment, it may be desirable to start at 30 mg once daily for 1 week to allow patients to adjust to duloxetine before increasing to the target dose of 60 mg once daily 1
Administration Considerations
- Duloxetine can be administered with or without food 1
- The medication should be swallowed whole - do not chew, crush, or open the delayed-release capsule 1
- Once increased to 60 mg daily, the dose can be given either as a single daily dose or as 30 mg twice daily, depending on the condition being treated 1
Monitoring After Dose Increase
- Assess for adverse effects at each follow-up visit after dose increase, particularly those related to higher doses 2, 3
- Monitor blood pressure regularly as duloxetine can cause modest hypertension 2, 3
- Common adverse events to watch for include nausea, dry mouth, headache, constipation, dizziness, and fatigue 4
- Most adverse events are mild to moderate in severity and often occur early in treatment 4
Further Dose Adjustments
- While 60 mg daily is the recommended therapeutic dose for most conditions, some patients may require doses up to 120 mg daily 1
- For neuropathic pain, there is no evidence that doses higher than 60 mg daily confer additional significant benefit, and higher doses are less well tolerated 1
- If further dose increases beyond 60 mg are needed, they should be made in increments of 30 mg once daily 1
Special Considerations
- For patients with renal impairment, consider a lower starting dose and more gradual increase in dosage 1
- Duloxetine is not recommended for patients with creatinine clearance <30 mL/min 5
- For elderly patients (≥65 years), maintain the 30 mg daily dose for 2 weeks before considering an increase to 60 mg daily 1
Potential Pitfalls
- Initiating treatment directly at 60 mg/day has been associated with higher discontinuation rates due to adverse events in some studies 6
- Discontinuation-emergent adverse events (most commonly nausea and dizziness) can occur in up to one-third of patients if duloxetine is abruptly discontinued 4
- If treatment needs to be discontinued, consider tapering the dose gradually to minimize withdrawal symptoms 5