What is the appropriate dosage and administration of Lansoprazole (Proton Pump Inhibitor) for a patient with a prescribed dose of 3mg/ml?

Lansoprazole 3mg/ml Dosing and Administration

For pediatric patients aged 1-17 years, lansoprazole should be dosed at 0.7-3.3 mg/kg/day (with weight-based adjustments: 15 mg daily for patients ≤30 kg or 30 mg daily for patients >30 kg), administered 30-60 minutes before a meal for optimal efficacy. 1, 2

Pediatric Dosing Guidelines

Age-Specific Recommendations

For children 1-11 years of age:

• Patients ≤30 kg: Start with 15 mg once daily 1, 3
• Patients >30 kg: Start with 30 mg once daily 1, 3
• Dose range: 0.7-3 mg/kg/day 1
• Maximum duration studied: 12 weeks 3

For adolescents 12-17 years of age:

• 15 mg daily for non-erosive GERD 4
• 30 mg daily for erosive esophagitis 4

Critical Administration Timing

Lansoprazole must be administered 30-60 minutes before a meal to maximize acid suppression. 2, 5 The inhibitory effect is optimized when food is consumed within 30 minutes after the dose. 2 For H. pylori eradication regimens specifically, administer 30 minutes before morning and evening meals. 2, 5

Formulation and Preparation

Available pediatric formulations include: 1

• Capsules that can be sprinkled onto soft foods or select juices
• Capsule contents administered through nasogastric tube (≥8 French)
• Strawberry-flavored orally disintegrating tablets
• Orally disintegrating tablets via oral syringe

Dose Escalation Protocol

If symptoms persist after 2+ weeks of initial therapy, the dose may be increased: 3

• Can escalate up to 30 mg twice daily in children 1-11 years 3
• In the pivotal trial, 24 of 66 patients required dose escalation 3

Important Safety Considerations

Age Restrictions

Lansoprazole is NOT indicated for infants <1 year of age. 3 A controlled trial in 162 infants (1 month to <12 months) showed no difference between lansoprazole and placebo (54% response rate in both groups). 3

Duration Limitations

Do not exceed recommended treatment duration in pediatric patients due to potential bone and cardiac effects observed in juvenile animal studies. 3 Juvenile rat studies showed:

• Heart valve thickening at doses ≥100 mg/kg/day (approximately 2.5× pediatric dose based on AUC) 3
• Bone growth impairment with delayed growth at similar doses 3
• Effects were most pronounced when dosing initiated at younger ages 3

Monitoring Parameters

Serum gastrin levels increase with lansoprazole therapy but typically remain within normal range. 3 In the pediatric study, median fasting gastrin increased 89% from baseline (51 to 97 pg/mL). 3

Common Pitfalls to Avoid

1. Do not administer without regard to meals - acid suppression is significantly reduced when not timed properly with food intake 2, 5

2. Do not use in infants <1 year - proven ineffective in this age group despite adequate drug exposure 3

3. Do not exceed 12 weeks without reassessment - longer-term safety in children 1-11 years has not been established 3

4. Do not assume dose equivalence with adult regimens - pediatric dosing is weight-based and differs from standard adult 30 mg daily dosing 1, 3

Adverse Events

Most common treatment-related adverse reactions in children 1-11 years: 3

• Constipation (5%)
• Headache (3%)

The safety profile in pediatric patients is generally similar to adults, with gastrointestinal events and headache being most frequent. 4