Ranitidine Bismuth Citrate

A to Z Drug Facts

 Action Suppresses gastric acid secretion and bismuth, which may aid in Helicobacter pylori eradication. Used in combination with clarithromycin, a macrolide antibiotic.

 Indications Treatment of active duodenal ulcers associated with H. pylori infection when used in combination with clarithromycin. Eradication of this bacterium reduces the risk of ulcer recurrence.

 Contraindications Standard considerations.

 Route/Dosage

ADULTS: PO 400 mg bid for 28 days in conjunction with clarithromycin (Biaxin) 500 mg tid for the first 14 days.

 Interactions

Antacids: High doses lower ranitidine and possibly bismuth levels. Clarithromycin: Increased ranitidine and bismuth levels. However, the combination is indicated to eradicate H. pylori and is not likely to be clinically relevant.

 Lab Test Interferences False positive urine protein with the multistix may occur while on ranitidine. Alternate testing with sulfosalicylic acid is recommended.

 Adverse Reactions

CNS: Headache. GI: Diarrhea; constipation; benign dark or black coloration of the tongue or feces.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established Porphyria: Do not use in patients with history of porphyria. Renal function impairment: Not recommended for use in patients with creatinine clearance < 25 ml/min or less. Treatment failure: Patients who fail to respond to therapy should not be retreated with a regimen containing clarithromycin.

 Administration/Storage

• Can be taken with or without food.
• Administer in combination with antibiotic agent (eg, clarithromycin) for first 14 days of therapy for the treatment of active duodenal ulcer.
• Refrigerate or store at room temperature. Protect from light in tightly closed container. Protect from moisture.

 Assessment/Interventions

• Obtain patient history including drug history and any known allergies. Note renal impairment and history of acute porphyria.
• Monitor CBC, renal and liver function test results.
• Ensure that clarithromycin is used concurrently during first 14 days of therapy.
• Monitor the adverse effects and report significant findings to physician.

 Patient/Family Education

• Instruct the patient to take ranitidine bismuth citrate twice daily as prescribed.
• Inform patient that in order for therapy to work, clarithromycin must be taken tid for first 14 days of therapy.
• Instruct patient not to take otc medications without consulting healthcare provider.
• Instruct the patient not to take an antacid at the same time as this combination therapy. This action may result in a decrease in plasma concentration of both bismuth and ranitidine.
• Advise patient to complete full course of therapy even if symptoms have resolved.
• Inform patient of potential adverse effects and precautions associated with separate drugs in this combination therapy
• Advise patient that bismuth may cause a temporary darkening of the tongue and stool.
• Instruct patient not to confuse the stool darkening with blood in the stool (melena). Occult blood testing may be necessary.
• Instruct patient to report any signs of bleeding to primary care provider.
• Instruct patient to notify primary care provider of any adverse reactions.
• Instruct female patients to notify primary care provider if they are pregnant or plan to become pregnant.
• Advise patients not to breastfeed while taking this medication.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts