Magazine article Drug Topics

The Acid Test

Magazine article Drug Topics

The Acid Test

Article excerpt

SmithKline Beecham has received approval from the Food & Drug Administration to market Tagamet HB as an over-the-counter remedy. ("HB" stands for heartburn.) The new product will be available in the early fall in a lower dose than that of prescription Tagamet. The recommended dose for Tagamet HB is two 100-mg tablets, taken up to twice a day; the Rx dose of Tagamet is usually 800 mg a day or the treatment of ulcers and 1600 mg a day for reflux esophagitis.

Indicated for symptomatic relief of heartburn, acid indigestion, and sour stomach, the OTC product has the same active ingredient--cimetidine--as the Rx drug. Tagamet will still be available by prescription for treatment of duodenal and gastric ulcers, erosive gastroesophageal reflux disease, severe upper gastrointestinal bleeding, and pathological hypersecretory conditions.

Tagamet is one of the most prescribed drugs in the history of the Rx marketplace, said Jack Ziegler, president-North America, SmithKline Beecham Consumer Healthcare, at a press briefing. Nearly 230 million Rxs have been filled in the United States alone and 500 million worldwide.

Tagamet works completely differently from the way antacids do, said Ziegler. Up to this point, if someone wanted to self-medicate for heartburn relief, he or she would use antacids to neutralize the acid already in the stomach. What Tagamet HB does, he emphasized, is actually block the production of stomach acid. On a per-dose basis, the drug will be priced "at a slight premium" in line with higher-end products such as Mylanta and Maalox, said Ziegler, and "lower than Pepcid on a per-dose basis."

SKB plans to support the Tagamet launch with "substantial" funding, but Ziegler declined to reveal exact figures for competitive reasons. Physician sampling will take place, as will an educational program for R. …

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