Frequently asked questions about heartburn and treatment with Prevacid®24HR

Pick a question below to get the answer.

Q: How is frequent heartburn defined?
A: Frequent heartburn is defined as heartburn occurring 2 or more days a week. In all 3 clinical trials for Prevacid®24HR, screened study subjects had heartburn an average of 4 days per week over the month prior to the screening visit.1-3


Q: What is Prevacid®24HR indicated for?
A: Prevacid®24HR (lansoprazole delayed-release capsules 15 mg/acid reducer) is indicated for the treatment of frequent heartburn (heartburn occurring 2 or more days a week) in adults 18 years or older.


Q: Can Prevacid®24HR be used by children?
A: No. Prevacid®24HR is labeled for use in adults 18 years of age and older.


Q: Is the medicine in Prevacid®24HR different from prescription Prevacid® (lansoprazole) 15 mg?
A: No. Both capsules contain the same active ingredient, lansoprazole. Prevacid®24HR is indicated for the treatment of frequent heartburn, and is the first and only OTC proton pump inhibitor (PPI) approved in its original formulation. Prescription Prevacid 15 mg is indicated for other acid-related conditions.


Q: What is the time to onset of action of Prevacid®24HR?
A: Like all PPIs, Prevacid®24HR is not intended for immediate relief. Prevacid®24HR may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.


Q: Is Prevacid®24HR safe for over-the-counter use?
A: Yes. For years, healthcare providers have prescribed Prevacid® (lansoprazole) to treat acid-related conditions in millions of people safely. For more information about the safety of Prevacid®24HR, please see Safety.


Q: What is the evidence that Prevacid®24HR is effective for the treatment of frequent heartburn?
A: Prevacid®24HR is clinically proven to treat frequent heartburn for a full 24 hours — day and night.2,3 Prevacid®24HR is the only OTC PPI specifically studied in a nighttime heartburn population: In one of 3 clinical studies of Prevacid®24HR, inclusion criteria required subjects to have had nighttime heartburn 2 or more days per week over the previous month.2 All 3 clinical trials, involving a total of over 1900 patients, showed that Prevacid®24HR was statistically significantly more effective than placebo for the treatment of frequent heartburn both day and night.2,3


Q: What is the difference between Prevacid®24HR and Prilosec OTC®?
A: While Prevacid®24HR and Prilosec OTC® are both OTC PPIs, they contain different active ingredients. Prevacid®24HR is the only PPI approved for OTC treatment of frequent heartburn that contains the active ingredient lansoprazole. Prilosec OTC®, like some private-label OTC PPIs, contains omeprazole magnesium. Prevacid®24HR is the first and only OTC PPI for the treatment of frequent heartburn approved in its original formulation.


Q: How is Prevacid®24HR supplied?
A: Prevacid®24HR is available in 14-count, 28-count and 42-count boxes. These sizes contain one, two, and three 14-day courses of treatment, respectively.

A 14-day course of therapy may be repeated every 4 months. Prevacid®24HR should not be taken for more than 14 days or more often than every 4 months unless the patient is otherwise directed by a health care professional.


Q: Where will my patients or customers be able to buy Prevacid®24HR?
A: Prevacid®24HR will be available at most major retail outlets, including Wal-Mart, Target, Costco, Walgreens, CVS, Kroger, and others.



Q: How much will Prevacid®24HR cost?
A: The average retail price for a 14-count box of Prevacid®24HR is $11.99. Depending on your patient's health care plan, Prevacid®24HR may cost less than the co-pay for a branded prescription medication for frequent heartburn.1,4


Q: How can I get more information about Prevacid®24HR?
A: Click on the link to sign up and receive news, information, and valuable offers on Prevacid®24HR.


Q: Will Prevacid® still be available as a prescription after Prevacid®24HR becomes available over-the-counter?
A: Yes, Prevacid® (lansoprazole) will still be available as a prescription medication for its currently approved indications. For full prescribing information for prescription Prevacid®, go to www.prevacid.com.


Q: What are the recommended storage conditions for Prevacid®24HR?
A: Prevacid®24HR should be stored out of high heat and humidity, protected from moisture, at a temperature of 20°C-25°C (68°F -77°F).


Q: What is the difference between Zegerid OTC™ and Prevacid®24HR?
A: The label for Zegerid OTC™ is very similar to that of Prevacid®24HR, reflecting class labeling for OTC PPIs. However, there are distinct differences, starting with the active ingredient. Zegrid OTC™ contains omeprazole, while Prevacid® 24HR contains lansoprazole. Additionally, since Zegerid OTC™ contains sodium bicarbonate, there is a warning related to patients on sodium-restricted diets (those with conditions such as hypertension, edema, etc). Each Zegerid OTC™ capsule contains 303 mg of sodium, which is 20% to 25% of the day's allowance (1200 mg/day to 1500 mg/day).5 Prevacid® 24HR is sodium free. Additionally, the direction instructs patients to take Zegerid OTC™ with a glass of water at least 1 hour prior to eating in the morning, while Prevacid®24HR can be dosed anytime prior to eating in the morning.

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References
1. Data on file, Novartis Consumer Health, Inc.
2. Kushner PR, Snoddy AM, Gilderman L, Peura DA. Lansoprazole 15 mg once daily for 14 days is effective for treatment of frequent heartburn: results of 2 randomized, placebo-controlled, double-blind studies. Postgrad Med. 2009;121(4): 67-75.
3. Peura DA, Riff DS, Snoddy AM, Fennerty MB. Clinical trial: lansoprazole 15 or 30 mg once daily vs placebo for treatment of frequent nighttime heartburn in self-treating subjects. Aliment Pharmacol Ther. 2009;30(5):459-468.
4. The Kaiser Family Foundation and Health Research and Educational Trust. Employer Health Benefits: 2009 Annual Survey. Menlo Park, CA, and Chicago, IL. 2009.
5. USDA National Agricultural Library. Dietary Reference Intakes: Electrolytes and Water. http://www.iom.edu/Global/News%20Announcements/~/media/442A08B899F44DF9AAD083D86164C75B.ashx. Accessed June 6, 2010.
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