Amlodipine besylate has U.S. Food and Drug Administration-approved indications for treating high blood pressure, chest pain due to heart disease and partial blockages of blood vessels around the heart. The medication also gets prescribed for relieving a condition called Raynaud's syndrome. Reflecting amlodipine's wide use, more than 30 branded and generic drug products contain the medication as an active ingredient.
Clinical studies involving adults and children as young as 6 years old summarised in the prescribing information for amlodipine revealed that daily doses of the medication lowered patients' blood pressure. The average decrease from baseline was 12/6 mm Hg for adults. The effect was not as significant for children, but it was still around 5/5 mm Hg.
Amlodipine also prevented the chest pain and tightness associated with both chronic stable angina and vasospastic angina in clinical trials. Patients taking the medication were able to continue exercising longer and reported fewer angina attacks.
Coronary Artery Disease
Significant numbers of patients at risk for hospitalisation or heart failure because of coronary artery blockage avoided complications by taking amlodipine.
While not an FDA-approved indication for the medication, some physicians prescribe amlodipine for treating Raynaud's syndrome. Amlodipine relieves the symptoms of the condition sometimes called Raynaud's phenomenon by dilating blood vessels. This returns natural colour to extremities that have turned white after a stressful experience or after being exposed to cold temperatures.
Adults should take between 5 mg and 10 mg of amlodipine each day. Daily recommended doses for children begin at 2.5 mg and top out at 5 mg.
Pfizer markets a single-ingredient amlodipine drug product under the brand name Norvasc. Actavis, Alkem, Apotex, Amneal, Aurobindo, Caraco, Cobalt, Dr. Reddy's Laboratories, Gedeon, Glenmark, Invagen, Lek, Lupin, Matrix, Mylan, Orchid, Ranbaxy, Roxane, Synthon, Teva, Upsher Smith, Torrent, Watson, Wockhardt and Zydus produce generic equivalents of Norvasc.
Caduet from Pfizer combines amlodipine with the cholesterol drug atorvastatin, and Lotrel from Novartis combines amlodipine with the vasodilator benazepril. Novartis also markets amlodipine and valsartan as the branded product Exforge and amlodipine-valsartan-hydrochlorothiazide as Exforge HCT. Last, the Japanese drug maker Daiichi Sankyo market the combination of amlodipine and olmesartan as Azor. Of these combination products, only Caduet has a generic competitor. Teva markets an unbranded amlodipine-atorvastatin capsule.