Normetec Special Precautions

Patients with Hypovolemia or Sodium Depletion: Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea, or vomiting, especially after receiving the first dose. Correction of this condition prior to administration of Amlodipine/Olmesartan Medoxomil (Normetec), or close medical supervision at the start of treatment, is recommended.
Other Conditions with Stimulation of the Renin-Angiotensin-Aldosterone System: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system, such as angiotensin II receptor antagonists, has been associated with acute hypotension, azotemia, oliguria, or rarely, acute renal failure.
Renovascular Hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Electrolyte Imbalance: Amlodipine/Olmesartan Medoxomil (Normetec) contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalaemia. Monitor serum electrolytes periodically.
Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies. Consider discontinuation of Amlodipine/Olmesartan Medoxomil (Normetec) in cases where no other etiology is identified.
Severe Obstructive Coronary Disease: As with all vasodilators, special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Effects on Ability to Drive and Use Machines: No data available.
Renal Impairment and Kidney Transplantation: There is no experience of the administration of Amlodipine/Olmesartan Medoxomil (Normetec) in patients with a recent kidney transplant or in patients with end-stage renal impairment (i.e. creatinine clearance <12 mL/min).
Hepatic Impairment: Since amlodipine is extensively metabolized by the liver, exposure to amlodipine and olmesartan medoxomil is increased in patients with hepatic impairment. Care should be taken when Amlodipine/Olmesartan Medoxomil (Normetec) is administered in patients with mild to moderate hepatic impairment. Use of Amlodipine/Olmesartan Medoxomil (Normetec) in patients with severe hepatic impairment is not recommended.
Use in Pregnancy & Lactation: See Use in Pregnancy & lactation regarding use in pregnancy and lactation.