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Ranitidine kinetics in chronic renal impairment
Clinical Pharmacology and Therapeutics
|November 1, 1983
Summary
Renal impairment significantly alters ranitidine pharmacokinetics, increasing its plasma concentration and half-life. Reduced renal clearance of ranitidine is directly linked to the severity of kidney dysfunction.
Area of Science:
- Pharmacology
- Nephrology
- Drug Metabolism
Background:
- Ranitidine is an H2-blocker used to reduce stomach acid.
- Renal impairment can affect drug pharmacokinetics, necessitating dose adjustments.
- Understanding ranitidine's behavior in kidney disease is crucial for patient safety.
Purpose of the Study:
- To investigate the pharmacokinetic effects of moderate to severe renal impairment on ranitidine.
- To correlate changes in ranitidine kinetics with the degree of renal impairment.
Main Methods:
- 16 patients with renal impairment were divided into two groups based on inulin clearance (ClIn).
- A single 150-mg oral dose of ranitidine was administered to each patient.
- Key pharmacokinetic parameters including maximum plasma concentration (MC), AUC, elimination half-life (t 1/2 beta), and renal clearance (ClR) were determined.
Main Results:
- Higher MC and delayed Tmax were observed compared to healthy subjects.
- t 1/2 beta was prolonged in both renal impairment groups and correlated with ClIn.
- Urinary excretion of unchanged ranitidine decreased significantly (18% in group I, 6% in group II).
- Ranitidine ClR strongly correlated with ClIn, indicating impaired renal excretion.
Conclusions:
- Moderate to severe renal impairment significantly alters ranitidine pharmacokinetics.
- The primary mechanism for these changes is reduced renal excretion of ranitidine.
- Dosage adjustments may be necessary in patients with renal impairment.