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Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Manufacturer: Par Pharmaceutical, Inc.

Score: 145.0

Quick Summary

Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride is a combination antimicrobial product used for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease. The drug is contraindicated in pregnant women, patients with severe renal impairment, and those with known hypersensitivity to its components. The recommended dosage is three capsules four times a day for 10 days, taken after meals and at bedtime, in combination with omeprazole twice a day. Special population considerations include use in pediatric and geriatric patients, as well as nursing mothers.

Key Clinical Findings and Indications

  • Treatment of Helicobacter pylori infection and duodenal ulcer disease
  • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence

Important Safety Information

Warning

Metronidazole has been shown to be carcinogenic in mice and rats, and its use is contraindicated in pregnant women.

Contraindications

  • Concurrent use of methoxyflurane
  • Disulfiram use within the last two weeks
  • Alcoholic beverage consumption during and for at least 3 days after therapy
  • Pregnancy
  • Severe renal impairment
  • Known hypersensitivity to product components

Adverse Reactions

  • Abnormal feces
  • Diarrhea
  • Nausea
  • Headache
  • Peripheral neuropathy
  • Stevens-Johnson syndrome
  • Toxic epidermal necrolysis

Dosing Recommendations

General Guidance

No dose adjustments are recommended for patients with mild to moderate renal impairment.

Helicobacter pylori infection and duodenal ulcer disease

Adult Dose

Three capsules four times a day for 10 days

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Contraindicated due to potential for carcinogenicity and fetal harm

Nursing Mothers

  • Caution is advised due to potential for metronidazole to be excreted in breast milk

Pediatric Use

  • Not established for use in pediatric patients infected with Helicobacter pylori

Geriatric Use

  • No significant differences in responses between elderly and younger patients, but caution is advised due to potential for decreased renal function

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