3.1. 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 mg, 1.25 mg, or 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. 3 For the rat, the highest dose was, on a mg/m2 basis, about twice the maximum recommended human dose. *
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 dose3 of 10 mg/day on a mg/m2 basis).
*Based on patient weight of 50 kg
Amlodipine Besylate 5 MG
Each tablet contains amlodipine besylate, USP equivalent to 5 mg amlodipine.
Dosage: See prescribing information
Store at 68-77 degrees F.
Protect from light and moisture.
Store in a tight, light-resistant container.
Keep out of the reach of children.
Mfg. by Invagen Pharmaceuticals, Hauppage, NY 11788
Mfg for Camber Pharmaceuticals, Piscataway, NJ 08854 Lot #
Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256
| AMLODIPINE BESYLATE |
amlodipine besylate tablet
|Labeler — Northwind Pharmaceuticals, LLC (036986393)|
|Registrant — Northwind Pharmaceuticals, LLC (036986393)|
|Northwind Pharmaceuticals, LLC||036986393||repack (51655-054)|
Revised: 09/2014 Northwind Pharmaceuticals, LLC
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