Magazine article Drug Topics

Patented Dosing Regimen Gains Ulcer Indication

Magazine article Drug Topics

Patented Dosing Regimen Gains Ulcer Indication

Article excerpt

Procter & Gamble Co. has received Food & Drug Administration approval to market Helidac Therapy for the treatment of patients with active duodenal ulcer associated with H. pylori infection. Helidac isn't a new drug, but rather it's a patented dosing regimen made up of bismuth subsalicylate, metronidazole, and tetracycline. Patients treated with Helidac Therapy should also receive an H2 antagonist.

One dose of Helidac Therapy is made up of two bismuth subsalicylate 262.4-mg chewable tablets, one metronidazole 250-mg tablet, and one tetracycline 500-mg capsule. Patients need to take each medication four times a day, with meals and at bedtime. To make it easier for patients to take 16 pills a day, P&G is packaging the product in a Helidac "kit." Each kit contains 14 punch-through cards, and each card contains a one-day supply of medication. The medication cards are perforated into four sections, which contain the morning, lunch, dinner, and bedtime doses of each medication. Patients should be instructed to chew the bismuth subsalicylate tablets and to swallow the metronidazole tablets and the tetracycline capsules with water.

In the clinical studies of Helidac Therapy, H. pylori was eradicated in up to 82% of patients. One year after treatment, 91% of patients had not had a recurrence of ulcer. According to the package insert, the most common side effects with the regimen are nausea (10%), diarrhea (5%), and abdominal pain (3%).

When counseling patients on the use of Helidac Therapy, pharmacists must keep in mind the common side effects of each individual medication. For example:

Tetracyclines may affect the efficacy of oral contraceptives and should not be used in pregnant women. The use of alcoholic beverages can cause a disulfiram-type reaction in patients taking metronidazole.

Tetracycline can cause photosensitivity reactions.

Bismuth subsalicylate may cause darkening of the stools and tongue. …

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