Monograph Details
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Gastrointestinal Tract
> Hyperacidity, GERD, and ulcers
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HELIDAC THERAPY |
| Manufacturer |
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Prometheus Labs, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antimicrobial/antibiotics. |
| Generic Name |
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Bismuth subsalicylate 262.4mg (112 chewable tabs), metronidazole 250mg (56 tabs), tetracycline HCl 500mg (56 caps). |
| Indications |
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In combination with an H2 blocker, to treat patients with an active duodenal ulcer associated with H. pylori infection. |
| Children |
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Not recommended. |
| Adults |
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Give the following regimen 4 times daily, with meals and at bedtime, with a full glass (8oz) water: Two bismuth subsalicylate 262.4mg chewable tabs, one metronidazole 250mg tab, one tetracycline 500mg cap. (See literature for dosing of concomitant H2 blocker therapy.) Treat for 14 days. |
| Contraindications |
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Renal or hepatic impairment. Aspirin allergy. Varicella or influenza in adolescents. Pediatric patients. Pregnancy (Cat.D). Nursing mothers. |
| Precautions |
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Previous therapy failure with metronidazole: not recommended. Blood dyscrasias. CNS diseases. Discontinue if abnormal neurological signs or skin erythema occurs. Avoid exposure to sun or UV light. |
| Interactions |
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Avoid alcohol during and for at least 1–3 days after therapy. Recent (within 2 weeks) therapy with disulfiram: not recommended. May potentiate oral hypoglycemics. May antagonize oral contraceptives (use non-hormonal back-up method). May interfere with bactericidal antiinfectives (e.g., penicillin). Caution with concomitant aspirin, probenecid, sulfinpyrazone. Tetracycline absorption reduced by antacids containing aluminum, magnesium or calcium; and by iron, zinc, sodium bicarbonate, and dietary calcium (clinical significance unknown). Monitor anticoagulants. Fatal renal toxicity with methoxyflurane. Metronidazole levels increased by cimetidine, other drugs that reduce activity of hepatic microsomal enzymes. Metronidazole levels reduced by phenytoin, phenobarbital, other drugs that increase activity of hepatic microsomal enzymes. Monitor phenytoin, lithium. May interfere with GI X-rays, liver function tests, others. |
| Adverse Reactions |
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Nausea, diarrhea, abdominal pain, superinfection, photosensitivity, pseudotumor cerebri, darkening of tongue and/or stool, melena, anal discomfort, anorexia, dizziness, paresthesia, vomiting, asthenia, constipation, insomnia, pain, upper respiratory infection. |
| How Supplied |
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Carton (14 blister cards)—1 (Each card has 4 doses; each dose is 2 tabs bismuth subsalicylate, 1 tab metronidazole, and 1 cap tetracycline) |
| Additional Resources |
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• Related Prescribing Note |
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