Prevacid (Lansoprazole) - Summary

PREVACID SUMMARY

The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules, PREVACID (lansoprazole) for Delayed-Release Oral Suspension and PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets is a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion.

PREVACID Delayed-Release Capsules, PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets and PREVACID For Delayed-Release Oral Suspension are indicated for:

SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual Therapy: PREVACID/amoxicillin

PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

MAINTENANCE OF HEALED DUODENAL ULCERS

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

HEALING OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.

For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment.

If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered.

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

See all Prevacid indications & dosage >>

PREVACID NEWS HIGHLIGHTS

Published Studies Related to Prevacid (Lansoprazole)

Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Assessing the Efficacy and Safety of Proton Pump Inhibitor Lansoprazole in Infants with Symptoms of Gastroesophageal Reflux Disease. [2008.12.01]
OBJECTIVE: To assess the efficacy and safety of lansoprazole [generic for Prevacid] in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a >/= 1-week course of nonpharmacologic management... CONCLUSIONS: This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.

Lansoprazole in globus pharyngeus: double-blind, randomized, placebo-controlled trial. [2008.10]
OBJECTIVE: To evaluate the effectiveness of once-daily lansoprazole [generic for Prevacid] in the typical globus pharyngeus patient, who presents with a normal head and neck examination and without other sinister otolaryngologic complaints. STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled trial. SETTING: Outpatient otolaryngology office practice... CONCLUSION: The globus pharyngeus patient who presents with a normal head and neck examination and without sinister otolaryngologic complaints does not benefit from once-daily lansoprazole therapy.

Effects of the proton pump inhibitor lansoprazole on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel. [2008.04]
Prasugrel and clopidogrel, thienopyridine prodrugs, are each metabolized to an active metabolite that inhibits the platelet P2Y(12) ADP receptor. In this open-label, 4-period crossover study, the effects of the proton pump inhibitor lansoprazole [generic for Prevacid] on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel were assessed in healthy subjects given single doses of prasugrel 60 mg and clopidogrel 300 mg with and without concurrent lansoprazole 30 mg qd...

Clinical response to 2 dosing regimens of lansoprazole in infants with gastroesophageal reflux. [2008.03]
Proton pump inhibitors such as lansoprazole [generic for Prevacid] are used in the treatment of gastroesophageal reflux disease (GERD), but dosing guidelines for infants have not been determined. The objective of this study was to assess the clinical efficacy of 2 dosing regimens of lansoprazole in infants with GERD using the revised infant gastroesophageal reflux questionnaire scores (I-GERQ-R)...

Initial treatment with lansoprazole in young dyspeptic patients with negative urea breath test result: a randomized controlled trial with 12-month follow-up. [2007.07]
INTRODUCTION: Although empirical antisecretory drug therapy is recommended to young dyspeptic patients without alarming features, the effectiveness of this approach remains undetermined. We evaluated the long-term effects of an initial 12-wk course of lansoprazole [generic for Prevacid] in young dyspeptic patients without Helicobacter pylori (H. pylori) infection... CONCLUSION: Lansoprazole is not effective in the initial management of young dyspeptic patients without H. pylori infection.

more studies >>

Clinical Trials Related to Prevacid (Lansoprazole)

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis [Completed]
The objective of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole 30 mg to oral lansoprazole 30 mg capsules in subjects with erosive esophagitis.

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent GERD [Completed]
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn [Completed]
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients [Completed]
This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn [Completed]
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.

more trials >>

PREVACID PATIENT REVIEWS / RATINGS / COMMENTS

Prevacid review by 23 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		GERD
Dosage & duration:		30mg taken 2x/day for the period of 5 years
Other conditions:		None
Other drugs taken:		None related
		Reported Results
Benefits:		Feels like it stops nearly all acid production, heartburn is gone. Due to cardia weakness stomach contents can still travel up esophagus but no burning sensation is felt. Regardless there is still some mild irritation in my esophagus.
Side effects:		Nothing noticeable. Soluble tablet has a slightly unpleasant aftertaste. Unknown if my vitamin B12 levels have been affected.
Comments:		Will likely be on Prevacid indefinitely due to GERD unless I have Nissen fundoplication surgery, and perhaps even still then. Had trouble with coverage under a new insurance company when I changed and I now take the soluble tablet instead of the capsule. If I discontinue the drug then heartburn returns fully after a couple of days.

Prevacid review by 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Severe Heartburn
Dosage & duration:		20 MG taken 2x/day for the period of 1 year
Other conditions:		None
Other drugs taken:		Vitamins
		Reported Results
Benefits:		Overall acid reduction; however, it could be sporadic. With taking the medication, still had to watch diet and avoid triggering foods. At times, the medication was not effective.
Side effects:		None
Comments:		Symptoms were so severe they would wake me up in the middle of the night, gasping for breath at times. This treatment reduced episodes such as this, but was not 100% effective at all times.

Prevacid review by care giver of 80 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		acid reflux
Dosage & duration:		1 40mg pill daily taken once daily for the period of once
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		She did not seem to have much benefit from it. She still had considerable gas & acid reflux.
Side effects:		No side effects. Her only complaint was that it did not work as well as she thought it would
Comments:		She was to take one pill in the morning with the first meal of the day. No other treatment instructions.