Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial.

BACKGROUND: Gastro-oesophageal reflux afflicts up to 7% of all infants. Histamine-2 receptor antagonists are the most commonly prescribed medications for this disorder, but few controlled studies support this practice. AIM: To evaluate the safety and efficacy of famotidine for infant gastro-oesophageal reflux disease. METHODS: Thirty-five infants, 1.3-10.5 months of age, entered an 8-week, multi-centre, randomized, placebo-controlled, two-phase trial: first 4 weeks, observer-blind comparison of famotidine 0.5 mg/kg and famotidine 1.0 mg/kg; second 4 weeks, double-blind withdrawal comparison (safety and efficacy) of each dose with placebo. RESULTS: No serious adverse events were reported. Eleven patients had 16 non-serious, possibly drug-related adverse experiences: 6 patients with agitation or irritability (manifested as head-rubbing in two), 3 patients with somnolence, 2 patients with anorexia, 2 with headache, 1 patient with vomiting, 1 patient with hiccups, and 1 patient with candidiasis. Of the 35 infants, 27 completed Part I. There were significant score improvements for famotidine 0.5 mg/kg in regurgitation frequency (P = 0.04), and for famotidine 1.0 mg/kg in crying time (P = 0.027) and regurgitation frequency (P = 0.004) and volume (P = 0.01). Eight infants completed Part II on double-blind treatment, which was insufficient for meaningful comparisons. CONCLUSIONS: Histamine-2 receptor antagonists may cause agitation and headache in infants. A possibly efficacious famotidine dose for infants is 0.5 mg/kg (frequency adjusted for age). As 1.0 mg/kg may be more efficacious in some, the dosage may require individualization based on response. Further sizeable placebo-controlled evaluations of histamine-2 receptor antagonists in infants with gastro-oesophageal reflux disease are warranted.

Stability of mycophenolate mofetil as an extemporaneous suspension.

OBJECTIVE: To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules. METHODS: Suspensions of MMF were prepared at room temperature and stored at 5, 25, 37, and 45 degrees C over a period of 50 to 210 days. The contents of MMF and its degradation product, mycophenolic acid, in the suspension were measured at various time points by HPLC. RESULTS: MMF suspensions were stable (as determined by the presence of > or = 90% of the labeled amount) at 45 degrees C for at least 11 days, at 37 degrees C for at least 28 days, at 25 degrees C for at least 28 days, and at 5 degrees C for at least 210 days. The suspension was also physically stable at 5 degrees C during the entire test period. CONCLUSIONS: The compounded MMF suspension was stable for at least 11 days at all the temperatures studied and for as long as 210 days at 5 degrees C. This formulation appears to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative period.

Standardized versus pharmacist-monitored individualized parenteral nutrition in low-birth-weight infants.

The clinical contribution and cost effectiveness of pharmacist involvement in peripheral-vein total parenteral nutrition (TPN) in a neonatal intensive-care unit was studied. Fourteen neonates who received a standardized TPN solution without pharmacist monitoring (Group 1) were compared with 14 neonates who received an individualized TPN solution with pharmacist monitoring (Group 2). Infants were excluded from the study if they received oral feeding, or TPN for less than five days, or were fluid-restricted. No significant difference in mean gestational age, birth weight, gestational size, age at initiation of therapy, duration of therapy, or daily amount of fluid administered was found between the two groups. The mean weight gain in Group 1 (4.9 g/day) was significantly less than in Group 2 (11.8 g/day) (p less than 0.02). The amount of protein provided to Group 2 (2.2 g/kg/day) was significantly greater than to Group 1 (1.9 g/kg/day) (p less than 0.01). The number of calories provided per day was greater for Group 2 (63 kcal/kg/day) than for Group 1 (53 kcal/kg/day) (p less than 0.001). When only those infants who received lipids were analyzed, Group 2 received significantly more lipid (2.0 g/kg/day) than group 1 (1.5 g/kg/day) (p less than 0.001). The mean daily cost was greater for Group 2; however, when cost was related to efficacy, Group-2 cost per gram of weight gain was lower than Group-1 cost. Pharmacist monitoring of an individualized program of TPN in neonates provided a greater mean daily weight gain, allowed a greater amount of nutrients to be provided, and was cost effective compared with the use of a standardized solution without pharmacist monitoring.