The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics
| Autor: | Aaron Dane, Paul D. Martin, Michael J Warwick, Dennis W. Schneck |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Magnesium Hydroxide Time Factors medicine.medical_treatment Biological Availability chemistry.chemical_element Aluminum Hydroxide Pharmacology Drug Administration Schedule Antacid Preparation chemistry.chemical_compound Pharmacokinetics Antacid medicine Humans Drug Interactions Rosuvastatin Rosuvastatin Calcium Sulfonamides Cross-Over Studies business.industry Magnesium Anticholesteremic Agents Aluminium hydroxide nutritional and metabolic diseases General Medicine Middle Aged Crossover study Fluorobenzenes Pyrimidines chemistry Area Under Curve Antacids Hydroxymethylglutaryl-CoA Reductase Inhibitors business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 24:1231-1235 |
| ISSN: | 1473-4877 0300-7995 |
| Popis: | Rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor used for the treatment of dyslipidaemia, may be co-administered with antacids in clinical practice. This trial assessed the effect of simultaneous and separated administration of an antacid preparation containing aluminium hydroxide 220 mg/5 mL and magnesium hydroxide 195 mg/5 mL (co-magaldrox 195/220) on the pharmacokinetics of rosuvastatin.A randomised, open-label, three-way crossover trial was performed. Healthy male volunteers (n = 14) received a single dose of rosuvastatin 40 mg alone, rosuvastatin 40 mg plus 20 mL antacid suspension taken simultaneously, and rosuvastatin 40 mg plus 20 mL antacid suspension taken 2 h after rosuvastatin on three separate occasions with a washout ofor = 7 days between each.The primary parameters were area under the rosuvastatin plasma concentration-time curve from time zero to the last quantifiable concentration (AUC(0-t)) and maximum observed rosuvastatin plasma concentration (C(max)) in the absence and presence of antacid.When rosuvastatin and antacid were given simultaneously, the antacid reduced the rosuvastatin AUC(0-t) by 54% (90% confidence interval [CI] for the treatment 0.40-0.53) and C(max) by 50% (90% CI 0.41-0.60). When the antacid was given 2 h after rosuvastatin, the antacid reduced the rosuvastatin AUC(0-t) by 22% (90% CI 0.68-0.90) and the C(max) by 16% (90% CI 0.70-1.01). The effect of repeated antacid administration was not studied and it cannot be discounted that this may have resulted in a stronger interaction than that observed here.Simultaneous dosing with rosuvastatin and antacid resulted in a decrease in rosuvastatin systemic exposure of approximately 50%. This effect was mitigated when antacid was administered 2 h after rosuvastatin. |
| Databáze: | OpenAIRE |
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