Levosulpiride Dosing for Prokinetic Use in Adults
The standard dosing regimen for levosulpiride as a prokinetic agent in adults is 25 mg three times daily (total 75 mg/day) for functional dyspepsia and delayed gastric emptying. 1
Standard Dosing Regimen
- 25 mg orally three times daily is the established dose that has been shown to accelerate gastric and gallbladder emptying 2
- This dosing schedule (75 mg/day total) is recommended as second-line treatment for functional dyspepsia when first-line therapies (PPIs, H2 blockers, or H. pylori eradication) have failed 1
- Treatment duration is typically 4 weeks, though some protocols extend to 20 days minimum 3, 4
Clinical Context and Positioning
The British Society of Gastroenterology guidelines position levosulpiride specifically as a second-line antipsychotic agent for functional dyspepsia management 1. This is important because:
- It should be reserved for patients who have not responded to standard acid suppression or prokinetic agents
- Careful explanation of the rationale for using an antipsychotic medication is required 1
- Patients must be counseled about the side effect profile before initiation 1
Alternative Dosing Considerations
While 75 mg/day (25 mg TID) is standard, some clinical practice data shows:
- 66.4% of patients receive 75 mg/day (25 mg three times daily) 4
- 33.6% receive 50 mg/day (likely 25 mg twice daily), suggesting dose adjustment based on tolerability 4
Critical Side Effects Requiring Monitoring
Hyperprolactinemia is the most significant adverse effect and occurs frequently:
- Levosulpiride blocks central D2 dopamine receptors, removing dopamine's inhibition of prolactin secretion 5
- Can cause serum prolactin levels >200 ng/mL in a significant number of patients 5
- Manifests as menstrual abnormalities and galactorrhea in women (galactorrhea occurred in 26.7% of patients in one study) 5, 4
- Other common side effects include somnolence (17.8%), fatigue (11.1%), and headache (11.5%) 4
Important Clinical Pitfalls
- Do not assume pituitary tumor when encountering very high prolactin levels (>200 ng/mL) in patients taking levosulpiride—this is a drug effect, not necessarily pathology 5
- Obtain careful drug history before ordering brain imaging for hyperprolactinemia 5
- The medication has a short half-life, which necessitates three-times-daily dosing for sustained effect 6
Mechanism Supporting This Dosing
At 25 mg three times daily, levosulpiride exerts its prokinetic effect through:
- D2 dopamine receptor antagonism in the enteric nervous system 2
- 5-HT4 serotonin receptor agonism, providing cholinergic effects 2
- This dual mechanism accelerates both gastric and gallbladder emptying 2, 3