The components of the HELIDAC Therapy (bismuth sub-salicylate, metronidazole, and tetracycline hydrochloride), in combination with an H₂ antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or a history of duodenal ulcer). Appropriate doses of H₂ antagonists for the treatment of active duodenal ulcers should be prescribed in all patients. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of HELIDAC Therapy and other antibacterial drugs, HELIDAC Therapy should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Adults: The recommended dosages are: bismuth subsalicylate, 525 mg (two 262.4 mg-chewable tablets), metronidazole, 250 mg (one 250-mg tablet), and tetracycline hydrochloride, 500 mg (one 500-mg capsule) taken four times daily (q.i.d.) for 14 days plus an H₂ antagonist approved for the treatment of acute duodenal ulcer. Patients should be instructed to take the medicines at mealtimes and at bedtime. The bismuth subsalicylate tablets should be chewed and swallowed. The metronidazole tablet and tetracycline hydrochloride capsule should be swallowed whole with a full glass of water (8 ounces). Concomitantly prescribed H₂ antagonist therapy should be taken as directed.

Ingestion of adequate amounts of fluid, particularly with the bedtime dose of tetracycline hydrochloride, is recommended to reduce the risk of esophageal irritation and ulcera-tion. (See ADVERSE REACTIONS.)

Missed doses can be made up by continuing the normal dosing schedule until the medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.

The HELIDAC Therapy is supplied in a carton containing patient instructions, patient reminders, and 14 blister cards, each card containing the following daily dosage:

8 bismuth subsalicylate 262.4-mg chewable tablets, each pink round tablet engraved “PG 11”

4 metronidazole 250-mg tablets, each white round tablet engraved “Z 2971”

4 tetracycline hydrochloride 500-mg capsules, each pale orange and white capsule printed “PG 12” in white ink

NDC 65483-495-14 carton containing 14 days of therapy

Store at controlled room temperature 20°-25°C (68°-77°F) [See USP].

Sold under U.S. Patents 5,256,684; 5,403,830; 5,407,688; and 5,601,848 PEPTO-BISMOL is the registered trademark of The Procter & Gamble Company. Bismuth subsalicylate tablets are manufactured by OSG Norwich Pharmaceuticals. Metronidazole 250-mg tablets, USP and tetracycline hydrochloride 500-mg capsules, USP are manufactured by IVAX Pharmaceuticals, Inc. for Prometheus Laboratories Inc. San Diego, CA 92121 REVISED FEBRUARY 2004. FDA Rev date: 7/24/2007

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