NEODOSE

INDICATIONS

• 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. No improvement in crying and irritability was provided by proton pump inhibitors in infants in a systematic review of 5 randomized clinical trials (n=430).
• 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.

 

CONTRAINDICATIONS

Contraindicated with rilpivirine-containing products.

PRECAUTIONS

• neuroendocrine tumors:
  • Increased serum chromogranin A (CgA) levels may occur and lead to false positive results in diagnostic investigations for neuroendocrine tumors; therapy interruption may be necessary prior to laboratory assessments.
• Phenylketonuria:
  • Use caution in patients with phenylketonuria, as oral disintegrating tablets contain phenylalanine.
• cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE):
  • New onset or worsening cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported with proton pump inhibitor use. Avoid using for longer than medically indicated and discontinue use if signs or symptoms of CLE or SLE develop.
• Hypomagnesemia:
  • Hypomagnesemia has been reported with prolonged administration (in most cases, greater than 1 year) of proton pump inhibitors. Concomitant use of drugs that cause hypomagnesemia may increase the risk. Monitoring is recommended during therapy. In some cases, hypomagnesemia was not reversed with magnesium supplementation and discontinuation of the proton pump inhibitor was necessary.
• Acute interstitial nephritis:
  • may occur (typically due to idiopathic hypersensitivity reaction); discontinue if it occurs.
• Cyanocobalamin (vitamin B12):
  • Cyanocobalamin (vitamin B12) deficiency may occur with long term use.
• 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.
• Respiratory:
  • PPIs, when used for oropharyngeal dysphagia (off-label use), may be associated with an increased risk of hospitalization due to aspiration and isolated laryngeal penetration; demonstrated in a retrospective cohort (n=293 children 2 years or younger).

 

ADVERSE EFFECTS

Hypergastrinemia and mild transaminase elevations are the only adverse effects reported in children who received lansoprazole for extended periods of time. Available data are limited to small studies of infants and children. In a retrospective, single-center, observational, case-control study of 136 children (1 year or older) having protracted diarrhea and stool analysis for Clostridium difficile, the use of PPI therapy was significantly higher in the patients with C difficile-associated diarrhea compared to the control group (22% vs 6%; odds ratio of 4.5 (95% CI, 1.4 to 14.4; p=0.006)).

 

ADMINISTRATION

The contents of a capsule can be mixed in 40 mL of apple juice and administered by NG tube. Do not use other liquids. The NG tube should be flushed with additional apple juice after administration. Data for successfully supplying patient-specific, partial doses of lansoprazole through pediatric/neonatal feeding tubes are lacking. In one study attempting to provide a partial dose (orally disintegrating tablet formulation) through a feeding tube, a 7.5 mg dose was administered successfully through an 8 French pediatric feeding tube; however, the same dose partially clogged a 6 French pediatric feeding tube (was able to clear with NS flush) and completely clogged a 5 French pediatric feeding tube.

There have been reports to the FDA of Teva’s lansoprazole delayed-release orally disintegrating tablets causing clogged and blocked oral syringes, and gastric and jejunostomy feeding tubes requiring patients to seek emergency medical assistance to have feeding tubes unclogged or removed and replaced. Tablets may not disintegrate entirely when water is added to form a suspension, and/or the tablets may disintegrate but later form clumps which can adhere to the inside walls of the tubes. The FDA recommends that the Teva brand of delayed-release orally disintegrating lansoprazole tablets not be dispensed to patients with feeding tubes.

 

MONITORING

Observe for symptomatic improvement within 3 days. Consider intraesophageal pH monitoring to assess for efficacy (pH greater than 4.0). Measure AST and ALT if duration of therapy is greater than 8 weeks. Hypomagnesemia has been reported with prolonged administration (in most cases, greater than 1 year). Monitor magnesium levels prior to initiation of therapy and periodically during therapy in patients expected to be on long-term therapy or patients receiving concomitant drugs such as digoxin or those that may cause hypomagnesemia.