NEODOSE

INDICATIONS

• Prevention and treatment of stress ulcers and GI hemorrhage: aggravated by gastric acid secretion.
• Apnea of prematurity: Reducing gastric acidity or increasing gastric motility for the sole purpose to reduce apnea episodes is not supported by the literature.
• Crying and irritability: In otherwise healthy term infants, histamine2 receptor antagonists or proton pump inhibitors should not be used for the treatment of crying and distress.
• Gastroesophageal Reflux (GER): The risks associated with acid reducing agents outweighs the benefits in preterm infants for GER. Acid blocking agents should not be used and if used in preterm infants, use sparingly. In otherwise healthy term infants, histamine2 receptor antagonists or proton pump inhibitors should not be used for the treatment of visible regurgitation.
• Gastroesophageal Reflux Disease (GERD): Proton pump inhibitors (PPIs) are the firstline agents for erosive esophagitis in infants and children with GERD. Histamine2 receptor antagonists are the second-line agent if PPIs are not available or are contraindicated. A duration of treatment for 4 to 8 weeks for GERD symptoms is recommended. Regularly reassess the need for long-term acid suppression. If no response after 4 to 8 weeks, then reevaluate for other causes of symptoms. H2RAs and PPIs are not recommended for extraesophageal symptoms (e.g. cough, wheezing, asthma), unless GERD symptoms are present and/or GERD has been diagnosed. A trial use of PPIs as a diagnostic test for GERD is not recommended in infants or in patients presenting with extraesophageal symptoms. However, in children with typical GERD symptoms, a trial of 4 to 8 weeks with a PPI may be used as a diagnostic test

FDA APPROVED INDICATION

• Intrvenous: Treatment of pathological hypersecretory conditions or intractable duodenal and gastric ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.
• Oral: Suspension is indicated for:
  • Short-term treatment of patients with symptoms of gastroesophageal reflux disease (GERD).
  • ort-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.
  • Peptic ulcer in pediatric patients 1 year or older.

PRECAUTIONS

• Gastrointestinal: Symptomatic response does not rule out gastric malignancy.
• Infection: Increased risk of infections (necrotizing enterocolitis, pneumonia, upper respiratory tract infections, sepsis, urinary tract infections, and Clostridium difficile infections) in infants and children on H2 blockers or PPIs demonstrated in case-control studies.
• Renal: CNS adverse effects have been reported in patients with moderate and severe renal insufficiency; dosage adjustment recommended.

ADVERSE EFFECTS

The use of H2 blockers in preterm infants has been associated with an increased risk for lateonset bacterial and fungal sepsis. Routine gastric acid suppression in neonates should be avoided. No short term adverse effects have been reported in infants and children, although data are limited to a few small studies. The most common (less than 5% of patients) adverse effects noted in adults were headache, dizziness, constipation, and diarrhea. The use of H2-blockers in preterm infants has been associated with facilitating Candida species colonization, and an increased risk for late-onset bacterial and fungal sepsis. In a prospective, multicenter, observational study comparing VLBW neonates receiving raNITIdine (n=91) to those not receiving raNITIdine (n=183), neonates receiving raNITIdine had an increased rate of infection (37.4% versus 9.8%; OR 5.5; 95% CI, 2.9 to 10.4), increased risk for NEC (9.8% versus 1.6%; OR 6.6; 95% CI, 1.7 to 25), and increased mortality (9.9% versus 1.6%). In a retrospective, case-control study, H2-blocker use in VLBW infants was associated with an increased incidence of NEC (OR 1.7; 95% CI, 1.34 to 2.19).

ADMINISTRATION

• IV Intermittent: Dilute to concentration of 2 to 4 mg/mL with 0.9% NS; give over a period of at least 2 minutes. Alternatively, dilute to concentration of 0.2 mg/mL with D5W or other compatible solution and infuse over 15 to 30 minutes.
• Oral: Shake oral suspension vigorously for 5 to 10 seconds prior to each use; unused constituted oral suspension should be discarded after 30 days.

MONITORING

Gastric pH may be measured to assess efficacy (greater than 4).