Introducing Zantac 360°™, Formulated With Famotidine

This article was sponsored by Sanofi Consumer Healthcare.

Heartburn (pyrosis) is caused by reflux of gastric acid content rising up from the stomach into the esophagus, resulting in a burning sensation in the chest area behind the sternum. Heartburn can also present with symptoms that include a burning sensation in the throat, acidic or bitter taste in the mouth, and chest pain when bending over or lying down.¹

The American College of Gastroenterology reports that more than 60 million Americans experience heartburn at least once a month.² Occasional heartburn is usually self-treated with nonprescription antacids or acid reducers, whereas frequent heartburn, occurring 2 or more days a week, may be a symptom of gastroesophageal reflux disease (GERD), which is a long-term condition that may require further evaluation.²

Given the large population affected by heartburn who may present to the pharmacy seeking relief, pharmacists have an important opportunity to provide information and recommendations regarding clinically proven, safe, and effective OTC options available that can both prevent and relieve occasional heartburn associated with acid indigestion and sour stomach.

HEARTBURN MANAGEMENT OPTIONS

In many cases, the first step in heartburn management is lifestyle modification. Dietary changes, such as eliminating foods and substances that tend to promote reflux (eg, carbonated beverages, citrus, fatty and spicy foods) may be helpful for those who experience heartburn symptoms.²

Additional lifestyle modifications can be recommended to help reduce heartburn (eg, smoking cessation, alcohol avoidance, weight loss for patients who may be overweight, changes to mealtime patterns).²

There are 3 therapeutic classes of nonprescription products available to manage heartburn: antacids; histamine₂ receptor antagonists (H2RAs), like Zantac 360°™; and proton pump inhibitors (PPIs). These 3 OTC options offer distinct benefits for patients (Table 1).^1,3

Antacids act rapidly to neutralize stomach acid, but these agents have a short duration of action and cannot prevent heartburn.^1,4,5 H2RAs are antisecretory agents that work to reduce acid production at its source by blocking H2 receptors on parietal cells to suppress gastric acid secretion in the stomach.^1,6-8 PPIs inhibit the gastric proton pump (H⁺/K⁺ ATPase) on parietal cells, inhibiting gastric acid secretion. PPIs are not intended for immediate relief because it may take 1 to 4 days of daily administration to reach full therapeutic effect.¹

Among these 3 class options, only H2RAs are indicated to both prevent and relieve heartburn.² Based on the results of a Sanofi Consumer Healthcare survey of heartburn sufferers (n = 300), 8 out of 10 surveyed agreed that they want a medicine that can be used flexibly to either prevent or relieve heartburn.⁹ Recognizing this need, Sanofi Consumer Healthcare has launched Zantac 360°™, formulated with famotidine, available as of spring 2021.³

ZANTAC 360°™

Zantac 360°™ is formulated with famotidine, the No. 1 pharmacist-recommended OTC H2RA blocker approved to both prevent and relieve heartburn.^a Zantac 360°™ may be taken before or after the onset of heartburn symptoms, empowering patients to control their heartburn when needed.

About famotidine

Famotidine is a highly selective and long-acting H2RA that causes a decrease in gastric acid by blocking H₂ receptors on parietal cells in the stomach.^6-8,10 It is an FDA-approved, safe, and effective medication for the short-term management of occasional heartburn in adults and children 12 years and older when used as directed.^3,10

Clinical effectiveness

Famotidine is clinically proven to prevent heartburn when taken as little as 15 minutes before eating or drinking, and it relieves heartburn fast.10 In a clinical study, significantly more participants who received 10 mg or 20 mg of famotidine reported complete relief of heartburn symptoms within 1 hour compared with those who received placebo (P <.001, 20 mg; P <.004, 10 mg).¹⁰ Evidence from clinical studies shows that famotidine can control stomach acid for up to 12 hours, day or night.^7,10-14,b

In separate comparative analyses, famotidine demonstrated control of stomach acid longer than an antacid, and it provided faster heartburn relief than a PPI when used as directed.^8,11,c

Flexible use

Zantac 360°™ is available in 2 strengths: Original Strength (10 mg) and Maximum Strength (20 mg). Zantac 360°™ is flexible. It may be taken before or after meals, which gives patients the option of taking it either in anticipation of heartburn or after the onset of heartburn symptoms.³ A single dose of Zantac 360°™ can prevent heartburn when taken 15 minutes prior to meals, or it can be taken when heartburn symptoms strike for fast, long-lasting acid control for up to 12 hours.^3,7,10-14,b

Zantac 360°™ offers less restrictive dosing than PPIs based on product labeling, and, when used as directed, patients can control their heartburn symptoms as needed.^1,3

ROLE OF THE PHARMACIST

Pharmacists play a key role in recommending OTC products for heartburn and providing education on potential heartburn triggers and lifestyle changes to help patients prevent or minimize their heartburn occurrence.⁵

Even with lifestyle changes, sometimes heartburn may occur. Zantac 360°™ can be safely recommended for the short-term management of heartburn. As an H2RA, Zantac 360°™ offers the best of both worlds. One dose of famotidine can prevent or relieve heartburn and control stomach acid longer than an antacid and provide faster relief than a PPI.^15,c

Refer to Table 2 for a summary of labeled information for Zantac 360°™ that can be used when sharing information with patients.³

^aBased on IQVIA ProVoice Survey data of OTC acid reducer product recommendations among 1237 pharmacist respondents (evaluation period of 12 months ending January 2021).
^bAcid control does not correlate with symptom relief.
^cBased on product labeling, PPIs may take 1 to 4 days for full effect.

REFERENCES

1. Over-the-counter (OTC) heartburn treatment. FDA. Updated March 12, 2021. Accessed April 8, 2021. https://www.fda.gov/drugs/information-
   consumers-and-patients-drugs/over-counter-otc-heartburn-treatment
2. Acid reflux. American College of Gastroenterology. Accessed April 8, 2021. https://gi.org/topics/acid-reflux/
3. Zantac 360^°TM. Product label. Accessed April 1, 2021. www.Zantac360professional.com
4. Taking antacids. MedlinePlus. Updated April 2, 2021. Accessed April 8, 2021. https://medlineplus.gov/ency/patientinstructions/000198.htm
5. Boardman HF, Heeley G. The role of the pharmacist in the selection and use of over-the-counter proton-pump inhibitors. Int J Clin Pharm. 2015;37(5):709-716. doi:10.1007/s11096-015-0150-z
6. Smith JL. Clinical pharmacology of famotidine. Digestion. 1985;32 Suppl 1:15-23. doi:10.1159/000199257
7. Ryan JR, Vargas R, McMahon FG, Chremos AN. Comparison of effects of oral and intravenous famotidine on inhibition of nocturnal gastric acidsecretion. Am J Med. 1986;81(4B):60-64. doi:10.1016/0002-9343(86)90601-7
8. Konturek JW, Beneke M, Koppermann R, Petersen-Braun M, Weingärtner U. The efficacy of hydrotalcite compared with OTC famotidine in the on-demand treatment of gastroesophageal reflux disease: a non-inferiority trial. Med Sci Monit. 2007;13(1):CR44-CR49.
9. Heartburn Sufferers Attitude Study (Sanofi proprietary research) n=300 heartburn sufferers, May 2021.
10. Lopez, He, and Korvick. Medical Officer’s Clinical Efficacy Review.NDA 20-325/S-015. Published November 2002. Accessed April 8, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020325_S015_PEPCID%20AC%20TABLETS_BIOPHARMR.pdf
11. Feldman M. Comparison of the effects of over-the-counter famotidine and calcium carbonate antacid on postprandial gastric acid. a randomized controlled trial. JAMA. 1996;275(18):1428-1431.
12. Reilly TG, Mann SG, Panos MZ, Walt RP. Low dose famotidine and cimetidine in single postprandial doses: a placebo controlled comparative study of overnight pH. Gut. 1995;37(3):325-328. doi:10.1136/gut.37.3.325
13. Reilly TG, Grimley CE, Usselmann B, et al. Low-dose famotidine and effervescent cimetidine in healthy subjects: a placebo-controlled overnight pH study. Ailment Pharmacol Ther. 1998;12(5):469-474. doi:10.1046/j.1365-2036.1998.00323.x
14. Hamilton MI, Sercombe J, Pounder RE. Control of intragastric acidity with over-the-counter doses of ranitidine or famotidine. Ailment Pharmacol Ther. 2001;15(10):1579-1583. doi:10.1046/j.1365-2036.2001.01091.x
15. Miner PB Jr, Allgood LD, Grender JM. Comparison of gastric pH with omeprazole magnesium 20.6 mg (Prilosec OTC) o.m. famotidine 10 mg (Pepcid AC) b.d. and famotidine 20 mg b.d. over 14 days of treatment. Aliment Pharmacol Ther. 2007;25(1):103-109. doi:10.1111/j.1365-2036.2006.03129.x