[.
NOTE: Since clarithromycin is used with ranitidine bismuth citrate, information on clarithromycin must also be consulted.
]
Action/Kinetics:
A complex of ranitidine and bismuth citrate which is freely soluble in water; solubility decreases as pH is decreased. The complex is more soluble than either ranitidine or bismuth citrate given separately. Is believed the greater solubility of the complex facilitates penetration of the drug into the mucous layer that protects the epithelial cells in the GI mucosa.
Peak levels
of ranitidine from complex: 0.5-5
hr.
t
1/2, elimination, ranitidine from ranitidine bismuth citrate: 2.8-3.1 hr. Ranitidine is eliminated through the kidneys.
t
1/2, terminal, bismuth: 11-28 days. Bismuth is excreted primarily in the feces.
Uses:
In combination with clarithromycin for treatment of active duodenal ulcers associated with
Helicobacter pylori infections.
NOTE: Ranitidine bismuth citrate should not be prescribed alone for the treatment of active duodenal ulcer.
Contraindications:
Hypersensitivity to the complex or any of its ingredients. Hangover. Use in those with a history of acute porphyria or in those with a C
CR less than 25 mL/min.
Special Concerns:
Use with caution during lactation. Safety and efficacy of ranitidine bismuth citrate plus clarithromycin in pediatric clients have not been determined.
Side Effects:
See also side effects for
Ranitidine. GI: N&V;, diarrhea, constipation, abdominal discomfort, gastric pain.
CNS: Headache, dizziness, sleep disorder, tremors (rare).
Hypersensitivity: Rash, anaphylaxis (rare).
Miscellaneous: Pruritus, gynecologic problems, taste disturbance, chest symptoms, transient changes in liver enzymes.
Laboratory Test Alterations:
False + test for urine protein using Multistix.
ALT, AST.
Drug Interactions:
-
Antacids / Possible
plasma levels of ranitidine and bismuth
-
Clarithromycin /
Plasma levels of ranitidine and bismuth
How Supplied:
Tablet: 400 mg
Dosage
?Tablets
Eradication of
H. pylori infection.
Ranitidine bismuth citrate: 400 mg b.i.d. for 4 weeks.
Clarithromycin: 500 mg t.i.d. for the first 2 weeks of therapy and either metronidazole, 500 mg b.i.d., or amoxicillin, 1 g b.i.d., or tetracycline, 500 mg b.i.d. for the first 2 weeks of therapy.