Bismuth Subsalicylate / Metronidazole / Tetracycline

Trade Names:
Helidac
- Carton containing blister cards that, in total, contain 112 bismuth subsalicylate 262.4 mg chewable tablets, 56 metronidazole 250 mg tablets, 56 tetracycline hydrochloride 500 mg capsules

Trade Names:
Pylera
- Capsules bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline 125 mg

Pharmacology

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Each of the ingredients is individually active in vitro against most strains of H. pylori . The relative contribution of systemic versus local antimicrobial activity for H. pylori eradication is not established.

Indications and Usage

Treatment of patients with H. pylori infection and duodenal ulcer.

Take in combination with an H ₂ antagonist.

Take in combination with omeprazole.

Contraindications

Pregnant or breast-feeding women; children; renal or hepatic function impairment; hypersensitivity to aspirin, salicylates, bismuth subsalicylate, metronidazole or other nitroimidazole derivatives, or any of the tetracyclines.

Dosage and Administration

PO 2 bismuth subsalicylate chewable tablets (262.4 mg/tablet), 1 metronidazole 250 mg tablet, and 1 tetracycline 500 mg capsule taken together 4 times daily for 14 days.

3 capsules 4 times daily, after meals and at bedtime for 10 days. Each capsule contains bismuth subcitrate potassium 140 mg, metronidazole 125 mg, or tetracycline 125 mg.

General Advice

• Administer adequate amounts of fluid, particularly at bedtime, to reduce the risk of esophageal irritation and ulceration caused by tetracycline.
• Do not take with milk or dairy products.

• Take at meal times and bedtime.
• Take with an H ₂ antagonist approved for treatment of acute duodenal ulcer.
• Bismuth subsalicylate tablets should be chewed and swallowed, while metronidazole and tetracycline should be swallowed whole with 8 oz of water.

• One omeprazole 20 mg capsule should be taken twice daily after the morning and evening meals for 10 days.

Storage/Stability

Store between 68° and 77°F.

Drug Interactions

Avoid during metronidazole use and for at least 24 h after administration.

May decrease absorption of tetracycline.

Possible increased anticoagulant effect and risk of bleeding.

Possible increased antidiabetic effect.

Tetracycline may reduce effectiveness.

Busulfan trough levels may be elevated, increasing the risk of toxicity (eg, hemorrhagic cystitis, veno-occlusive disease).

Tetracycline may reduce effectiveness.

Metronidazole has been reported to cause psychosis.

May decrease metronidazole Cl.

May reduce metronidazole plasma levels, decreasing the efficacy.

May decrease absorption of tetracycline.

Metronidazole may increase lithium blood levels.

Tetracycline has caused fatal renal toxicity.

May reduce elimination of tetracycline.

Coadministration with tetracycline may increase the risk of benign intracranial hypertension.

Tetracycline excretion may be increased.

Laboratory Test Interactions

Metronidazole may interfere with AST, ALT, LDH, trigylcerides, and nevu Kinase glucose.

Bismuth absorbs x-rays and may interfere with GI diagnostic procedures.

Adverse Reactions

Cardiovascular

Palpitation (1%); MI.

CNS

Headache (8%); asthenia (4%); dizziness (3%); anxiety, insomnia, paresthesia (1%); benign intracranial hypertension.

Dermatologic

Maculopapular rash, rash (1%).

EENT

Pharyngitis (2%).

GI

Abnormal stool (16%); nausea (12%); abdominal pain, diarrhea, dyspepsia (9%); taste perversion (5%); melena (3%); anorexia, constipation, tongue discoloration, vomiting (2%); anal discomfort, dry mouth, duodenal ulcer, flatulence, gastritis, gastroenteritis, GI hemorrhage (1%).

Genitourinary

Vaginitis (4%); urinary abnormality (2%).

Lab Tests

Lab test abnormalities (3%); increased ALT (2%); increased AST (1%).

Musculoskeletal

Back pain (2%).

Respiratory

Upper respiratory infection (2%); cough, rhinitis, sinusitis (1%).

Miscellaneous

Flu syndrome (5%); infection, pain (2%); chest pain (1%).

Precautions

Pregnancy

Category D . Contraindicated during pregnancy.

Lactation

Secreted into breast milk.

Children

Safety and effectiveness not established. Contraindicated in children.

Renal Function

Contraindicated.

Hepatic Function

Contraindicated.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth.

Blood dyscrasia

Use with caution.

CNS

Convulsive seizures and peripheral neuropathy have been reported with metronidazole.

Darkening of stools or tongue

Bismuth subsalicylate may cause a harmless darkening of the tongue and stools.

Outdated tetracycline

Do not use because of the risk nephrotoxicity.

Pseudomembranous colitis

Consider in a patient in whom diarrhea develops.

Pseudotumor cerebri (benign intracranial hypertension)

Has been reported.

Ultraviolet exposure

Tetracycline may increase susceptibility to sunburn.

Overdosage

Symptoms

Coma, confusion, convulsions, CV collapse, death, hyperpnea, hyperpyrexia, lethargy, nausea, pulmonary or cerebral edema, respiratory failure, tachycardia, tinnitus, vomiting.

Ataxia, nausea, vomiting.

GI symptoms, including diarrhea, nausea, and vomiting.

Patient Information

• Advise patients to drink adequate amounts of fluid, particularly with the nighttime dose of tetracycline, to reduce the risk of esophageal irritation and ulceration.
• Instruct patients taking Helidac that bismuth subsalicylate should be chewed and swallowed, while metronidazole and tetracycline should be swallowed whole with 8 oz of water.
• Instruct patients taking Pylera that one omeprazole 20 mg capsule should be taken twice daily, after the morning and evening meals.
• Advise patients that bismuth subsalicylate may cause harmless darkening of the tongue and stool.
• Advise patients to consult health care provider if aspirin is taken and ringing in the ears occurs. It may be necessary to stop aspirin until the course of bismuth salicylate is completed.
• Advise patients that tetracycline may cause hormonal contraceptives to be less effective, and to consider a different or additional form of contraception. The health care provider should be notified immediately if pregnancy occurs.
• Advise patients to avoid alcoholic beverages while taking metronidazole and for at least 1 day afterward.

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