Amlodipine Excipient Content: Wheat, Milk, and Lactose
Amlodipine formulations commonly contain lactose as an excipient, but do not contain wheat or milk proteins. 1
Lactose Content in Amlodipine
Lactose is present in many amlodipine formulations as a filler/excipient material, though the specific amount varies by manufacturer and is often not disclosed on drug leaflets. 1, 2
Research demonstrates that lactose-amlodipine mixtures can cause drug instability through the Maillard reaction between the primary amine group of amlodipine and lactose, particularly in the presence of moisture and magnesium stearate. 1
Lactose-free amlodipine formulations are recommended from safety, quality, efficacy, and manufacturing cost perspectives due to this chemical incompatibility. 1
A 2025 study found that 50% of surveyed medication leaflets contain lactose as an excipient, but only 25.35% specify the exact lactose amount, making it difficult for patients with lactose intolerance to determine if a specific amlodipine product is safe for them. 2
Wheat and Milk Protein Content
Amlodipine does not contain wheat or wheat-derived ingredients. 3
Amlodipine does not contain milk proteins (casein or whey), though it may contain lactose, which is the sugar derived from milk but does not contain the proteins that cause milk allergy. 1, 2
Clinical Implications for Patients with Food Sensitivities
For patients with celiac disease or wheat allergy: Amlodipine is safe to use as it does not contain wheat, gluten, or wheat-derived starches. 3
For patients with milk protein allergy: Amlodipine is safe to use as it does not contain milk proteins, even if lactose is present as an excipient. 1
For patients with lactose intolerance: The small amount of lactose in amlodipine tablets (typically <100 mg per tablet) is generally well-tolerated even by lactose-intolerant patients, as symptoms typically require lactose intake equivalent to more than 0.5 pint of milk per day (approximately 6 grams of lactose). 3
Pharmacists should check specific product leaflets or contact manufacturers directly to confirm lactose content for severely lactose-intolerant patients, as this information is inconsistently disclosed. 2
Liquid amlodipine formulations developed for pediatric use typically use sucrose syrup rather than lactose, making them suitable alternatives for patients concerned about lactose content. 4