What is the recommended use of levosulpride (prokinetic agent) in pediatric patients?

Levosulpiride Use in Pediatric Patients

Levosulpiride is not recommended for use in pediatric patients due to insufficient safety data and significant risk of adverse effects including extrapyramidal symptoms and hyperprolactinemia.

Safety Concerns and Contraindications

Levosulpiride, a prokinetic agent that functions as a D2 dopamine receptor antagonist and serotonin 5HT4 receptor agonist, has several important safety concerns that make it unsuitable for pediatric use:

• Extrapyramidal symptoms: Levosulpiride can cause significant neurological adverse effects including tremor, stiffness, and dystonia 1. These effects correlate positively with duration of treatment.

• Hyperprolactinemia: As a D2 receptor antagonist, levosulpiride causes significant elevation of serum prolactin levels, which can result in endocrine disturbances 2.

• Lack of pediatric safety data: There are no established dosing guidelines or safety profiles for levosulpiride in children.

Alternative Prokinetic Options for Pediatric Patients

The American Academy of Pediatrics specifically addresses prokinetic agents in their guidelines on gastroesophageal reflux management:

• Limited evidence for all prokinetics: "After careful review, guidelines unequivocally state that there is insufficient evidence to support the routine use of any prokinetic agent for the treatment of GERD in infants or older children" 3.

• Metoclopramide concerns: Even metoclopramide, the most commonly used prokinetic, has received a black box warning regarding adverse effects, with side effects reported in 11-34% of patients including drowsiness, restlessness, and extrapyramidal reactions 3.

Management Recommendations for Pediatric GERD

For pediatric patients with gastroesophageal reflux disease requiring pharmacological intervention:

First-line options:

1. Proton Pump Inhibitors (PPIs) for children ≥1 year:

   • Omeprazole: 0.7-3.3 mg/kg/day (maximum 80 mg/day) 4
   • Esomeprazole: 0.7-3.3 mg/kg/day 4
   • Rabeprazole: 20 mg daily for children 12-17 years 4

2. H2 Receptor Antagonists as alternative therapy:

   • Ranitidine: 5-10 mg/kg/day divided in 2-3 doses 4
   • Famotidine: 1 mg/kg/day divided in 2 doses 4

Non-pharmacological approaches:

• Weight management if needed
• Avoiding trigger foods
• Proper positioning after meals
• Smaller, more frequent meals

Monitoring and Follow-up

• Assess symptom improvement after 2 weeks of therapy
• For non-responders, consider follow-up endoscopy after 8-12 weeks of treatment
• Monitor for adverse effects with long-term therapy

Important Caveats

• Avoid prokinetics in general: The risk-benefit ratio for prokinetic agents in children is unfavorable 3.
• Consider alternative diagnoses: If acid suppression therapy is ineffective, reassess the diagnosis of GERD and consider conditions such as cyclic vomiting, rumination, gastroparesis, or eosinophilic esophagitis 3.
• Surgical options: For severe cases unresponsive to medical management, surgical interventions like fundoplication may be considered, but careful patient selection is essential 3.

In conclusion, levosulpiride should not be used in pediatric patients due to safety concerns and lack of evidence supporting its efficacy in this population. Alternative evidence-based approaches for managing pediatric GERD should be pursued instead.