General Information

Prevacid delayed-release capsules and Prevacid Solutab are proton pump inhibitors (PPIs).

Prevacid delayed-release capsules and Prevacid Solutab are indicated for the:

• Treatment of active duodenal ulcer in adults.
• Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults.
• Maintenance of healed duodenal ulcers in adults.
• Treatment of active benign gastric ulcer in adults.
• Healing of nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcer in adults. 
• Risk reduction of NSAID-associated gastric ulcer in adults.
• Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.
• Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. 
• Maintenance of healing of EE in adults.
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults

Recommended Adult Dosage by Indication

Duodenal Ulcers:

Short-Term Treatment 15 mg Once daily for 4 weeks.

Maintenance of Healed: 15 mg Once daily

Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence: 

Triple Therapy: PREVACID or PREVACID SoluTab 30 mg Twice daily for 10 or 14 days

Amoxicillin 1 gram Twice daily for 10 or 14 days

Clarithromycin 500 mg Twice daily for 10 or 14 days

Dual Therapy: PREVACID or PREVACID SoluTab 30 mg Three times daily for 14 days

Amoxicillin 1 gram Three times daily for 14 days

Benign Gastric Ulcer

Short-Term Treatment: 30 mg Once daily for up to 8 weeks

NSAID-Associated Gastric Ulcer

Healing: 30 mg Once daily for 8 weeks

Risk Reduction: 15 mg Once daily for up to 12 weeks

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD: 15 mg Once daily for up to 8 weeks

Short-Term Treatment of Erosive Esophagitis: 30 mg Once daily for up to 8 weeks

Maintenance of Healing of Erosive Esophagitis

15 mg Once daily

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

60 mg Once daily

Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of Age

In clinical studies, PREVACID was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below:

Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis

≤30 kg 15 mg Once daily for up to 12 weeks

>30 kg 30 mg Once daily for up to 12 weeks

Pediatric Patients 12 to 17 Years of Age

Short-Term Treatment of Symptomatic GERD

Non-erosive GERD 15 mg Once daily for up to 8 weeks

Erosive Esophagitis 30 mg Once daily for up to 8 weeks

Mechanism of Action

Prevacid delayed-release capsules and Prevacid Solutab are proton pump inhibitors (PPIs). Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+ , K+ )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

Side Effects

Adverse effects associated with the use of Prevacid may include, but are not limited to, the following:

• diarrhea
• abdominal pain
• nausea
• constipation

Clinical Trial Results

Duodenal Ulcer

In a US multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of PREVACID once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of PREVACID than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with PREVACID 15 mg

PREVACID 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day.

In a second US multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of PREVACID once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after four weeks was significantly higher with both doses of PREVACID than with placebo. There was no evidence of a greater or earlier response with the higher dose of PREVACID. Although the 15 mg dose of PREVACID was superior to ranitidine at four weeks, the lack of significant difference at two weeks and the absence of a difference between 30 mg of PREVACID and ranitidine leaves the comparative effectiveness of the two agents undetermined.

Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence

Randomized, double-blind clinical studies performed in the US in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of PREVACID in combination with amoxicillin and clarithromycin as triple 14 day therapy or in combination with amoxicillin as dual 14 day therapy for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of two different eradication regimens were established: Triple therapy: PREVACID 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily Dual therapy: PREVACID 30 mg three times daily/amoxicillin 1 g three times daily. All treatments were for 14 days. H. pylori eradication was defined as two negative tests (culture and histology) at four to six weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. A randomized, double-blind clinical study performed in the US in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) compared the efficacy of PREVACID triple therapy for 10 and 14 days. This study established that the 10 day triple therapy was equivalent to the 14 day triple therapy in eradicating H. pylori.

Maintenance of Healed Duodenal Ulcers

PREVACID has been shown to prevent the recurrence of duodenal ulcers. Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed duodenal ulcers. Patients remained healed significantly longer and the number of recurrences of duodenal ulcers was significantly less in patients treated with PREVACID than in patients treated with placebo over a 12 month period.

Gastric Ulcer

In a US multicenter, double-blind, placebo-controlled study of 253 patients with endoscopically documented gastric ulcer, the percentage of patients healed at four and eight weeks was significantly higher with PREVACID 15 and 30 mg once a day than with placebo. Patients treated with any PREVACID dose reported significantly less day and night abdominal pain along with fewer days of antacid use and fewer antacid tablets used per day than the placebo group.

Healing of NSAID-Associated Gastric Ulcer

In two US and Canadian multicenter, double-blind, active-controlled studies in patients with endoscopically confirmed NSAID-associated gastric ulcer who continued their NSAID use, the percentage of patients healed after eight weeks was statistically significantly higher with 30 mg of PREVACID than with the active control. A total of 711 patients were enrolled in the study, and 701 patients were treated.

Risk Reduction of NSAID-Associated Gastric Ulcer

In one large US, multicenter, double-blind, placebo- and misoprostol-controlled (misoprostol blinded only to the endoscopist) study in patients who required chronic use of an NSAID and who had a history of an endoscopically documented gastric ulcer, the proportion of patients remaining free from gastric ulcer at four, eight, and 12 weeks was significantly higher with 15 or 30 mg of PREVACID than placebo. A total of 537 patients were enrolled in the study, and 535 patients were treated.

Symptomatic Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD: In a US multicenter, double-blind, placebo-controlled study of 214 patients with frequent GERD symptoms, but no esophageal erosions by endoscopy, significantly greater relief of heartburn associated with GERD was observed with the administration of lansoprazole 15 mg once daily up to eight weeks than with placebo. No significant additional benefit from lansoprazole 30 mg once daily was observed. The intent-to-treat analyses demonstrated significant reduction in frequency and severity of day and night heartburn.

In two US, multicenter double-blind, ranitidine-controlled studies of 925 total patients with frequent GERD symptoms, but no esophageal erosions by endoscopy, lansoprazole 15 mg was superior to ranitidine 150 mg (twice daily) in decreasing the frequency and severity of day and night heartburn associated with GERD for the eight week treatment period. No significant additional benefit from lansoprazole 30 mg once daily was observed.

Erosive Esophagitis

In a US, multicenter, double-blind, placebo-controlled study of 269 patients entering with an endoscopic diagnosis of esophagitis with mucosal grading of two or more and grades three and four signifying erosive disease. In this study, all PREVACID groups reported significantly greater relief of heartburn and less day and night abdominal pain along with fewer days of antacid use and fewer antacid tablets taken per day than the placebo group. Although all doses were effective, the earlier healing in the higher two doses suggests 30 mg daily as the recommended dose. PREVACID was also compared in a US, multicenter, double-blind study to a low dose of ranitidine in 242 patients with erosive reflux esophagitis. PREVACID at a dose of 30 mg was significantly more effective than ranitidine 150 mg twice daily. In addition, patients treated with PREVACID reported less day and nighttime heartburn and took less antacid tablets for fewer days than patients taking ranitidine 150 mg twice daily.

In a US, multicenter, double-blind, active-controlled study, 30 mg of PREVACID was compared with ranitidine 150 mg twice daily in 151 patients with erosive reflux esophagitis that was poorly responsive to a minimum of 12 weeks of treatment with at least one H2-receptor antagonist given at the dose indicated for symptom relief or greater, namely, cimetidine 800 mg/day, ranitidine 300 mg/day, famotidine 40 mg/day or nizatidine 300 mg/day. PREVACID 30 mg was more effective than ranitidine 150 mg twice daily in healing reflux esophagitis.

Maintenance of Healing of Erosive Esophagitis

Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed esophagitis. Patients remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in patients treated with PREVACID than in patients treated with placebo over a 12 month period.

In a US, randomized, double-blind study, PREVACID 15 mg daily (n=100) was compared with ranitidine 150 mg twice daily (n=106), at the recommended dosage, in patients with endoscopically-proven healed erosive esophagitis over a 12 month period. Treatment with PREVACID resulted in patients remaining healed (Grade 0 lesions) of erosive esophagitis for significantly longer periods of time than those treated with ranitidine (p<0.001). In addition, PREVACID was significantly more effective than ranitidine in providing complete relief of both daytime and nighttime heartburn. Patients treated with PREVACID remained asymptomatic for a significantly longer period of time than patients treated with ranitidine.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In open studies of 57 patients with pathological hypersecretory conditions, such as ZollingerEllison syndrome (ZES) with or without multiple endocrine adenomas, PREVACID significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia and pain. Doses ranging from 15 mg every other day to 180 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery and below 5 mEq/hr in patients with prior gastric surgery. Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients. PREVACID was well-tolerated at these high-dose levels for prolonged periods (greater than four years in some patients). In most ZES patients, serum gastrin levels were not modified by PREVACID. However, in some patients, serum gastrin increased to levels greater than those present prior to initiation of lansoprazole therapy.