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.

CONTRAINDICATIONS

Contraindicated in patients receiving cisapride due to precipitation of life-threatening arrhythmias. Cardiac arrhythmias and hypotension have been reported following the rapid IV bolus administration of cimetidine.

PRECAUTIONS

• Infections:
  • 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.

ADVERSE EFFECTS

Known adverse effects of cimetidine in adults include mental confusion, seizures, thrombocytopenia, neutropenia, nausea, vomiting, diarrhea, gynecomastia, rash, and muscular pain. Cimetidine has been reported to increase the serum level and potentiate toxicity of other drugs such as chlordiazepoxide, diazepam, lidocaine, metronidazole, nifedipine, phenytoin, propranolol, theophylline, warfarin, and certain tricyclic antidepressants. 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

• Intermittent IV infusion: Dilute in D5W or other compatible solution to a finalconcentration of 6 mg/mL and infuse over 15 to 20 minutes.
• Oral: Administer doses with meals and at bedtime. Do not administer simultaneouslywithantacids since antacids may interfere with cimetidine absorption.

MONITORING

Consider esophageal pH monitoring to assess for efficacy (pH greater than 4). Observe for impaired consciousness and reduced spontaneous movements.