Starting Dose for Epuris (Isotretinoin)
Begin Epuris at 0.5 mg/kg/day for the first month, then increase to 1.0 mg/kg/day as tolerated, administered in two divided doses with meals. 1, 2, 3
Standard Dosing Protocol
Initial Month
- Start at 0.5 mg/kg/day divided into two doses taken with food 1, 2
- This lower initial dose minimizes early side effects while allowing tolerance assessment 1
- For a 70 kg patient, this translates to approximately 35 mg/day 2
Maintenance Dosing (Month 2 onwards)
- Increase to 1.0 mg/kg/day as tolerated 1, 2, 3
- Continue two divided doses with meals 3
- For a 70 kg patient, this becomes approximately 70 mg/day 2
Critical Administration Requirement
- Must be taken with meals - failure to do so significantly decreases absorption 1, 2, 3
- The drug is highly lipophilic and requires dietary fat for optimal bioavailability 1, 2
Alternative Dosing for Moderate Acne
For treatment-resistant or quick-relapsing moderate acne (not severe nodulocystic disease):
- Low-dose regimen: 0.25-0.4 mg/kg/day provides comparable efficacy with significantly fewer side effects 1, 2
- This translates to approximately 20 mg/day for most adults 4
- Equal relapse rates compared to conventional dosing 1
Special Circumstances
Extremely Severe Cases
- Consider starting below 0.5 mg/kg/day 1, 2
- May require concomitant oral corticosteroids to prevent isotretinoin-induced flares 1, 2
Dose Escalation Considerations
- The FDA label permits adjustments up to 2 mg/kg/day for very severe disease with scarring or primarily truncal involvement 3
- Before increasing dose, verify patient compliance with taking medication with food 3
Treatment Duration and Goals
- Continue until reaching cumulative dose of 120-150 mg/kg to minimize relapse 1, 2, 3
- Standard treatment course: 15-20 weeks 2, 3
- May discontinue earlier if nodule count reduced by >70% before completing 15-20 weeks 3
- Continue at least 2 months after achieving clear skin to reduce relapse frequency 2
Important Caveats
Avoid once-daily dosing - safety not established; twice-daily administration is required 3
Avoid intermittent dosing (e.g., one week per month) - associated with significantly higher relapse rates and inferior lesion reduction compared to continuous daily dosing 1, 2
The dose-dependent nature of side effects makes the graduated approach (starting at 0.5 mg/kg/day) particularly important, as lower doses cause significantly fewer adverse effects while maintaining therapeutic efficacy when given for adequate duration 1, 2.