Drugs demonstrated to be effective for gastroesophageal reflux disease in children

• 3 to <5 kg – 2.5 mg
• 5 to <10 kg – 5 mg
• ≥ 10 kg – 10 mg

Children ≥1 year:

• 1 mg/kg daily, given 30 minutes before meal(s)^§
• May increase to 1 mg/kg twice daily if needed for symptomatic improvement

Adults:

• 20 or 40 mg once daily

• Safety data for long-term use of PPIs in children are in general reassuring^*.
• Frequent (2 to 14%) – Headache, diarrhea, abdominal pain, nausea, rash, constipation.
• Infrequent or rare – Increased risk of C. difficile and other enteric infections; increased risk for lower respiratory tract infections in infants (pediatric reports). Malabsorption of magnesium, calcium, and, to a lesser extent, vitamin B12 and iron (adult reports).
• United States FDA approval is for use in pediatric patients 1 month and older.

• Capsules can be opened and sprinkled on soft food (10, 20, and 40 mg)
• Flavored oral suspension (2 mg/mL)
• Granules for oral suspension (2.5 and 10 mg)

• Similar to other PPIs^*.
• Avoid using in patients on sodium-restricted diets; contains 303 mg (13 mmol) sodium per 20 or 40 mg capsule; 460 mg (20 mmol) sodium per 20 or 40 mg packet.
• United States FDA approval is for adults 18 years and older.

• Capsules should not be opened (20 and 40 mg capsules)
• Powder for oral suspension should be dissolved in water only (20 or 40 mg packets)

• 3 to 5 kg – 2.5 mg
• 5 to 7.5 kg – 5 mg
• 7.5 to 12 kg – 10 mg

Children 1 to 11 years (daily, given 30 minutes before first meal each day):

• Weight <20 kg – 10 mg
• Weight >20 kg – 10 mg or 20 mg^§

Children ≥12 years and adults:

• 20 or 40 mg daily

• Similar to other PPIs^*.
• Indication in infants is for erosive esophagitis due to acid-mediated GERD.

• Capsules can be opened and sprinkled on soft food (20 and 40 mg)
• Granules for oral suspension (2.5, 5, 10, 20, and 40 mg packets
• Intravenous formulation available^¥

• 1 mg/kg daily, given 30 minutes before meal(s)^§
• May increase to 1 mg/kg twice daily, if needed, for symptomatic improvement

Adults:

• 15 to 30 mg once daily

• Similar to other PPIs^*.

• Capsules can be opened and sprinkled on soft food, or given via NG or other enteral tube suspended in apple juice (15 and 30 mg capsules)
• Flavored oral suspension (3 mg/mL)
• Orally disintegrating tablets can be dissolved in the mouth or suspended in water and given by oral syringe or NG or other enteral tube (15 and 30 mg tablets)

• 30 mg once daily

• Similar to other PPIs^*.

• Capsules can be opened and sprinkled on applesauce and consumed immediately or suspended in water and given by oral syringe (30 mg capsules)
• Orally disintegrating tablets can be dissolved in the mouth or suspended in water and given by oral syringe or NG or other enteral tube (30 mg tablets)

• Weight 15 to <40 kg – 20 mg
• Weight ≥40 kg – 40 mg

Adults:

• 40 mg once daily

• Similar to other PPIs^*.

• Oral tablets should be swallowed whole (20 and 40 mg).
• Granules for oral suspension (40 mg packets)
• Intravenous formulation available^¥

• 20 mg once daily, given 30 minutes before the first meal each day

• Similar to other PPIs^*.

• Oral tablets should be swallowed whole (20 mg)

• 30 to 40 mg/kg per day divided in 4 doses^§

Adult dose:

• 400 to 800 mg twice daily

• Safety data for the use of H2RAs in children are in general reassuring. H2RAs produce less profound acid suppression than PPIs, which may be an advantage in some clinical scenarios^*.
• Tachyphylaxis (tolerance) commonly develops with chronic use (ie, >6 weeks).
• Frequent – Headache, dizziness, diarrhea, abdominal pain, somnolence (adult reports).
• Infrequent or rare – CNS disturbance, gynecomastia, idiosyncratic or immune-mediated hypersensitivity including organ toxicity (liver, kidney) and hematologic abnormalities (myelosuppression, thrombocytopenia, neutropenia, anemia, pancytopenia) (mostly adult reports). Rapid intravenous administration has been associated with bradycardia and hypotension. Increased risk of C. difficile and other enteric infections (pediatric and adult reports).
• Cimetidine is a moderate inhibitor of CYP metabolism and can increase levels of some co-administered medications, such as theophylline, SSRIs, warfarin, and cisapride. For specific interactions, refer to the drug interactions program included with UpToDate.

• Oral tablets may be crushed (200, 300, 400, and 800 mg)
• Flavored oral solution (300 mg/5 mL)
• Intravenous formulation available^¥

• 1 mg/kg per day, divided into 2 doses^§

Adults:

• 20 mg/dose twice daily

• Similar to cimetidine, except that famotidine lacks anti-androgenic activity (gynecomastia) and does not inhibit CYP metabolism or alter co-administered drugs metabolized by CYP^*.

• Tablets may be crushed (10, 20, and 40 mg)
• Flavored powder for suspension (40 mg/5 mL)
• Intravenous formulation available^¥
• Chewable tablets (10 mg, with antacid [calcium carbonate-magnesium hydroxide antacid])

• 10 mg/kg/day divided into 2 doses^§

Adults:

• 150 mg/dose twice daily or 300 mg once daily at bedtime

• Similar to cimetidine, except that nizatidine lacks anti-androgenic activity (gynecomastia) and does not inhibit CYP metabolism or alter co-administered drugs metabolized by CYP^*.
• Low levels of NDMA contaminants have been found in some nizatidine products^†.

• Oral tablets may be crushed (150 and 300 mg)
• Flavored oral solution (15 mg/mL)

• 0.6 to 0.8 mg/kg per day, divided into 4 doses, given 30 minutes before each meal and at bedtime
• Maximum 10 mg per dose

Adults:

• 5 to 20 mg 4 times daily

• Cisapride is not available in the United States. The only way that United States clinicians can obtain cisapride is through a limited-access program developed by Janssen Pharmaceuticals and the United States FDA^**.
• Frequent:
  • Abdominal pain, diarrhea, headache, dizziness.
• Infrequent or rare:
  • NOTE – Cisapride may increase the risk for potentially fatal ventricular arrhythmias due to QT prolongation.
  • NOTE – If prescribed, requires assessment of risk factors for cardiac arrhythmias, including ECG and serum electrolytes^¶¶ and close attention to avoiding co-administration of drugs that can elevate cisapride blood levels and/or also prolong the QT interval, including macrolide antibiotics, azole antifungals, and protease inhibitors. For specific interactions, refer to the drug interactions program included with UpToDate.
  • Hypersensitivity reactions (rash, bronchospasm), convulsions, dystonic reactions (mostly adult reports).

• Restricted availability in the United States^**