What is the recommended dose of Acotiamide (acotiamide) for functional dyspepsia?

Acotiamide Dosing for Functional Dyspepsia

The recommended dose of acotiamide for functional dyspepsia is 100 mg three times daily before meals, with an extended-release formulation option of 300 mg once daily also being effective. 1, 2, 3, 4

Dosing Options and Evidence

Standard Dosing

• Immediate-release formulation: 100 mg three times daily (t.i.d.) before meals
  • This dosage was determined as optimal in phase II studies 2
  • Demonstrated significant improvement in functional dyspepsia symptoms, particularly for postprandial distress syndrome (PDS) 3, 4

Extended-Release Option

• Extended-release formulation: 300 mg once daily
  • Comparable efficacy to the standard 100 mg t.i.d. dosing 1
  • May improve patient adherence through simplified dosing regimen
  • In a randomized, double-blind study, the responder rates were nearly identical: 92.66% for ER 300 mg once daily vs. 94.39% for 100 mg t.i.d. 1

Clinical Efficacy and Mechanism

Acotiamide works primarily through:

• Inhibition of acetylcholinesterase
• Enhancement of acetylcholine release in the enteric nervous system
• Antagonism of muscarinic receptors 3

These mechanisms result in:

• Enhanced gastric accommodation
• Accelerated gastric emptying
• Improved gastric contractility 3, 5

Treatment Response and Monitoring

• Symptom improvement can be observed within 1-2 weeks of treatment 4, 5
• Primary efficacy is seen in PDS symptoms:
  • Postprandial fullness
  • Early satiation
  • Upper abdominal bloating 3
• Long-term safety has been confirmed in studies up to one year 4

Safety Profile

• Generally well-tolerated with minimal adverse effects
• Most common side effect is headache 1
• No significant safety concerns in long-term use (up to 1 year) 4
• No significant drug interactions reported in the available evidence

Treatment Context

According to the British Society of Gastroenterology guidelines, acotiamide is considered a prokinetic treatment option for functional dyspepsia, though with a weak recommendation and low quality of evidence 6. It should be noted that acotiamide may not be available in all countries, as it is primarily used in Asia and has limited availability elsewhere.

Practical Considerations

• For optimal effect, acotiamide should be taken before meals
• If using the extended-release formulation, it can be taken once daily
• Treatment duration in clinical trials typically ranged from 2-4 weeks for initial assessment of efficacy 1, 5
• Long-term treatment appears safe for patients with ongoing symptoms 4

When prokinetics are ineffective, tricyclic antidepressants (starting at low doses such as amitriptyline 10 mg daily) may be considered as second-line therapy for functional dyspepsia 6.