No

Histamine H₂ Antagonist

In combination with clarithromycin for the treatment of active duodenal ulcer associated with H. pylori infection; not to be used as monotherapy

C

Hypersensitivity to ranitidine or bismuth compounds or components; acute porphyria

Avoid use in patients with Cl_cr <25 mL/minute; do not use for maintenance therapy or for >16 weeks/year

>1%:

Central nervous system: Headache (14%), dizziness (1% to 2%)

Gastrointestinal: Diarrhea (5%), nausea/vomiting (3%), constipation (2%), abdominal pain, gastric upset (<10%), darkening of the tongue and/or stool (60% to 70%), taste disturbance (11%)

Miscellaneous: Flu-like symptoms (2%)

<1%: Rash, pruritus, anemia, thrombocytopenia, elevated LFTs

See individual monographs

As a complex of ranitidine and bismuth citrate, gastric acid secretion is inhibited by histamine-blocking activity at the parietal cell and the structural integrity of H. pylori organisms is disrupted; additionally bismuth reduces the adherence of H. pylori to epithelial cells of the stomach and may exert a cytoprotectant effect, inhibiting pepsin, as well. Adequate eradication of Helicobacter pylori is achieved with the combination of clarithromycin.

See individual monographs

Distribution: Ranitidine: 1.7 L/kg

Protein binding: Bismuth: 90%; Ranitidine: 15%

Metabolism: Ranitidine: Metabolized to N-oxide, S-oxide, and N-desmethyl metabolites

Half-life: Complex: 5-8 days; Bismuth: 11-28 days; Ranitidine: 3 hours

Time to peak serum concentration: Bismuth: 1-2 hours; Ranitidine: 0.5-5 hours; Time to peak effect of complex: 1 week

Elimination: Bismuth: Clearance: 50 mL/minute; Ranitidine: Clearance: 530 mL/minute; ~30% of ranitidine and <1% of bismuth is excreted in the urine

Adults: Oral: 400 mg twice daily for 4 weeks with clarithromycin 500 mg 2 times/day for first 2 week

Dosing adjustment in hepatic impairment: No dosage change necessary

Note: Most patients not eradicated of H. pylori following an adequate course of therapy that includes clarithromycin will have clarithromycin-resistant isolates and should be treated with an alternative multiple drug regimen

May be taken without regard to food

(13) C-urea breath tests to detect H. pylori, endoscopic evidence of ulcer healing, CBCs, LFTs, renal function tests

May cause dizziness

May cause anemia; use caution with clozapine and carbamazepine

No information available to require special precautions

60% to 70% of patients will have darkening of the tongue and/or stool; 11% experience taste disturbance

Take as directed, with food. Do not supplement therapy with OTC medications. This drug may cause darkening of tongue or stool and may change your taste sensation. Report unresolved headache (prescriber may recommend something for relief), dizziness, diarrhea, constipation (prescriber may recommend something for relief), weakness, or loss of appetite. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Tablet: 400 mg (ranitidine 162 mg, trivalent bismuth 128 mg, and citrate 110 mg)