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HELIDAC THERAPY
Hyperacidity, GERD, and ulcers
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Drug Name:

HELIDAC THERAPY Rx

Generic Name and Formulations:
Bismuth subsalicylate 262.4mg (112 chewable tabs), metronidazole 250mg (56 tabs), tetracycline HCl 500mg (56 caps).

Company:
Prometheus Labs, Inc.

e-Prescribe this drug via Surescripts


Therapeutic Use:

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Indications for HELIDAC THERAPY:

In combination with an H2 blocker, to treat patients with duodenal ulcer disease associated with H. pylori infection.

Adult Dose for HELIDAC THERAPY:

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.

Children's Dose for HELIDAC THERAPY:

Not recommended.

Pharmacological Class:

Antimicrobial/antibiotics.

Contraindications:

Renal impairment. Aspirin allergy. Concomitant methoxyflurane (fatal renal toxicity). Within 2 weeks of disulfiram. Concomitant alcohol or other products containing propylene glycol (during and for at least 3 days after therapy).

Warnings/Precautions:

Blood dyscrasias. CNS diseases. Discontinue if abnormal neurological signs or skin erythema occurs. Avoid exposure to sun or UV light. Hepatic impairment. Elderly. Pregnancy (Cat.D); fetal, maternal toxicity possible. Nursing mothers: not recommended.

Interactions:

See Contraindications. May potentiate hypoglycemics. May antagonize oral contraceptives (use non-hormonal back-up method). May interfere with bactericidal anti-infectives (eg, 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. 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:

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.

Metabolism:

Metronidazole, tetracycline (hepatic).

Elimination:

Renal, fecal.

Generic Availability:

NO

How Supplied:

Carton (14 blister cards)—1 (Each card has 4 doses; each dose is 2 tabs bismuth subsalicylate, 1 tab metronidazole, and 1 cap tetracycline)

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