PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets (十二)
eeks and 15% (10/66) took it for 12 weeks.
The most frequently reported (2 or more patients) treatment-related adverse reactions in patients 1 to 11 years of age (N=66) were constipation (5%) and headache (3%).
Twelve to 17 years of age
In an uncontrolled, open-label, U.S. multicenter study, 87 adolescent patients (12 to 17 years of age) with symptomatic GERD were treated with PREVACID for 8 to 12 weeks. Baseline upper endoscopies classified these patients into two groups: 64 (74%) nonerosive GERD and 23 (26%) erosive esophagitis (EE). The nonerosive GERD patients received PREVACID 15 mg daily for 8 weeks and the EE patients received PREVACID 30 mg daily for 8 to 12 weeks. At baseline, 89% of these patients had mild to moderate overall GERD symptoms (assessed by investigator interviews). During 8 weeks of PREVACID treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of GERD symptoms based on diary results.
Twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after 8 weeks of PREVACID treatment. One patient remained unhealed after 12 weeks of treatment (Table 3).
Table 3: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 12 to 17 GERD Final Visit % (n/N)
* Symptoms assessed by patient diary (parents/caregivers as necessary). † No data available for 5 patients. ‡ Data from one healed patient was excluded from this analysis due to timing of final endoscopy.
Symptomatic GERD (All Patients)
Improvement in Overall GERD Symptoms* 73.2% (60/82)†
Nonerosive GERD
Improvement in Overall GERD Symptoms* 71.2% (42/59)†
Erosive Esophagitis
Improvement in Overall GERD Symptoms* 78.3% (18/23)
Healing Rate‡ 95.5% (21/22)‡
In these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45 pg/mL at baseline to 64 pg/mL [interquartile range (25th to 75th percentile) of 44 to 88 pg/mL] at the final visit. (Normal serum gastrin levels are 25 to 111 pg/mL.)
The safety of PREVACID Delayed-Release Capsules has been assessed in these 87 adolescent patients. Of the 87 adolescent patients with GERD, 6% (5/87) took PREVACID for less than 6 weeks, 93% (81/87) for 6 to 10 weeks, and 1% (1/87) for greater than 10 weeks.
The most frequently reported (at least 3%) treatment-related adverse reactions in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). Treatment-related dizziness, reported in this package insert as occurring in less than 1% of adult patients, was reported in this study by 3 adolescent patients with nonerosive GERD, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting).
8.5 Geriatric UseNo dosage adjustment of PREVACID is necessary in geriatric patients. The incidence rates of PREVACID-associated adverse reactions and laboratory test abnormalities are similar to those seen in younger patients [see Clinical Pharmacology (12.3)].
8.6 Renal ImpairmentNo dosage adjustment of PREVACID is necessary in patients with renal impairment. The pharmacokinetics of lansoprazole in patients with various degrees of renal impairment were not substantially different compared to those in subjects with normal renal function [see Clinical Ph |
