Olmesartan STELLA 10 mg

Rx

Indications

• Treatment of hypertension.

Dosage

• The usual dosage in adult is 10 to 20 mg of olmesartan medoxomil, once daily.
• The starting dose is 5 to 10 mg per day. The dose may be adjusted according to age and symptoms, but should not exceed 40 mg daily.

Administration

• Administered orally.

• Hypersensitivity to any of the ingredients of the drug.
• Second and third trimesters of pregnancy.
• Biliary obstruction.
• The concomitant use of olmesartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment.

Possible adverse reactions include:

• Dizziness, headache, chest pain, fatigue, peripheral edema, flu-like symptoms;
• Increased blood triglycerides, increased blood uric acid;
• Bronchitis, pharyngitis, cough, rhinitis;
• Gastroenteritis, diarrhea, abdominal pain, nausea, indigestion;
• Arthritis, back pain, bone pain;
• Hematuria, urinary tract infection;
• Increased liver enzymes, increased blood urea, increased blood creatine phosphokinase.

• Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of olmesartan medoxomil.
• Other conditions associated with stimulation of the renin-angiotensin-aldosterone system: Increased risk of severe hypotension and renal failure when patients have bilateral renal artery stenosis or unilateral renal artery stenosis when treated with drugs that affect the renin-angiotensin-aldosterone system.
• When olmesartan medoxomil is used in patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. Use of olmesartan medoxomil is not recommended in patients with severe renal impairment. There is no experience of the administration of olmesartan medoxomil in patients with a recent kidney transplant or in patients with end-stage renal impairment.
• Olmesartan medoxomil in patients with hepatic impairment is not recommended.
• The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
• The combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended.
• ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
• The combination of lithium and olmesartan medoxomil is not recommended.
• Special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
• The use of olmesartan medoxomil is not recommended in patients with primary aldosteronism.
• Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil few months to years after drug initiation.
• As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
• Olmesartan STELLA 10 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• The use of Olmesartan is contraindicated during the second and third trimester of pregnancy, and during lactating.
• Olmesartan has minor or moderate influence on the ability to drive and use machines. Dizziness or fatigue may occasionally occur in patients taking antihypertensive therapy, which may impair the ability to react.