Important Notice: Zantac (Ranitidine) Has Been Withdrawn from the Market
Ranitidine (Zantac) was withdrawn from the U.S. market by the FDA in 2020 due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen, and should not be prescribed or used in children or adults.
While historical dosing information exists, this medication is no longer available or recommended for clinical use. Below is the historical dosing information for reference only.
Historical Pediatric Dosing Information (For Reference Only)
Oral Dosing for GERD and Peptic Ulcer Disease
For children aged 1 month to 16 years, the recommended oral dose was 5-10 mg/kg/day divided into 2-3 doses, with a maximum of 300 mg/day. 1, 2
Age-Specific Oral Dosing:
- Treatment of active duodenal/gastric ulcers: 2-4 mg/kg twice daily, maximum 300 mg/day 2
- Maintenance of healing: 2-4 mg/kg once daily, maximum 150 mg/day 2
- GERD and erosive esophagitis: 5-10 mg/kg/day in 2 divided doses 2
- Erosive esophagitis (severe): Up to 150 mg four times daily in adults; pediatric dosing extrapolated from adult data 2
Intramuscular/Intravenous Dosing
For acute situations (such as anaphylaxis as second-line therapy), the IM dose was 1 mg/kg per dose, with a maximum single dose of 50 mg. 3, 1
- IV dosing for critically ill children: 1.5 mg/kg IV every 6 hours was most effective for maintaining gastric pH ≥4 4
- Alternative IV dosing: 0.75 mg/kg IV every 6 hours (less effective than higher dose) 4
Formulation Considerations
- Effervescent tablets (25 mg): Citrus-flavored, dissolved in 5 mL water; preferred by 71% of children over peppermint-flavored syrup 5
- Syrup formulation: 15 mg/mL, peppermint-flavored 5
Pharmacokinetic Data in Children
- Single 75 mg dose in children 4-11 years: Peak concentration (Cmax) of 477 ng/mL occurred at 2.5 hours, with a half-life of 2.0 hours 6
- Duration of action: Maintained elevated gastric pH for 5-6 hours 6
Renal Impairment Adjustments
For children with creatinine clearance <50 mL/min, dosing should be reduced to every 24 hours, with potential increase to every 12 hours if clinically necessary. 2
Current Clinical Alternatives
Since ranitidine is no longer available, consider these alternatives for pediatric acid suppression:
- Proton pump inhibitors (PPIs): More effective than H2-blockers for erosive esophagitis 1
- Other H2-receptor antagonists: Famotidine (if available and not similarly affected)
- Antacids: For symptomatic relief only
Important Caveat
H2-receptor antagonists develop tachyphylaxis within 6 weeks of continuous use and provide only 6-hour acid suppression, requiring 2-3 times daily dosing. 1 This limitation, combined with the withdrawal of ranitidine, makes PPIs the preferred first-line therapy for most pediatric acid-related disorders requiring chronic management.