Amlodipine nonclinical toxicology
| Amlodipine |
|---|
| NORVASC®, AMLODIPINE®, AMLODIPINE BESYLATE® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Dosage Forms and Strengths |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| Clinical Studies |
| How Supplied/Storage and Handling |
| Patient Counseling Information |
| Labels and Packages |
| Clinical Trials on Amlodipine |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
13 Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day.10 For the rat, the highest dose was, on a mg/m2 basis, about twice the maximum recommended human dose.11
Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose12 of 10 mg/day on a mg/m2 basis).
10
Based on patient weight of 50 kg
11
Based on patient weight of 50 kg
12
Based on patient weight of 50 kg[1]
References
- ↑ "NORVASC (AMLODIPINE BESYLATE) TABLET [CARDINAL HEALTH]". Retrieved 6 March 2014.