SEVIKAR

What it is

SEVIKAR is a fixed-dose combination tablet containing olmesartan medoxomil and amlodipine as besilate, available in four strengths: 20/5 mg, 20/10 mg, 40/5 mg, and 40/10 mg. SEVIKAR is a combination of two antihypertensive drugs: olmesartan medoxomil, an angiotensin receptor blocker, and amlodipine besilate, a dihydropyridine calcium channel blocker. The combination of these active ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dosage of SEVIKAR is one tablet daily, with or without food. Treatment should not be initiated with this combination; patients receiving olmesartan medoxomil and amlodipine from separate tablets may be switched to SEVIKAR tablets containing the same component doses, or those whose blood pressure is not adequately controlled on either monotherapy may be switched to combination therapy with SEVIKAR. For patients whose blood pressure is not adequately controlled on SEVIKAR 20/5, titration to SEVIKAR 40/5 is recommended, and if not adequately controlled on SEVIKAR 40/5, titration to SEVIKAR 40/10 is recommended. No adjustment of the recommended dose is generally required for elderly patients. No adjustment of the recommended dose is required for patients with mild to moderate impairment of renal function.

Key safety warnings

Symptomatic hypotension may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting, especially after receiving the first dose; correction of this condition prior to administration of SEVIKAR, or close medical supervision at the start of treatment, is recommended. Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation, with intestinal biopsies often demonstrating villous atrophy; if a patient develops these symptoms during treatment, other etiologies should be excluded and SEVIKAR should be considered for discontinuation if no other etiology is identified. Hyperkalaemia may occur during treatment with olmesartan medoxomil, especially in the presence of renal impairment and/or heart failure; serum electrolytes should be monitored periodically, and concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products which may increase potassium level may lead to increased serum potassium, requiring close monitoring in at-risk patients. Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with olmesartan medoxomil; SEVIKAR should be immediately discontinued in patients who develop angioedema, and should not be re-administered. Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. Mild to moderate peripheral oedema was the most common adverse event in clinical trials with amlodipine, with incidence ranging from 3.0 to 10.8% in the 5 to 10 mg dose range.

Contraindications

SEVIKAR is contraindicated in patients who are hypersensitive to any component of the tablet or to dihydropyridines, pregnant women, patients with severe renal impairment, patients with severe hepatic impairment or biliary obstruction, and patients with diabetes who are taking aliskiren. Due to the amlodipine component, SEVIKAR is also contraindicated in patients with cardiogenic shock, acute myocardial infarction within the first 4 weeks, and unstable angina pectoris.

PBS listing

Information on PBS listing, including listed strengths, item count, restriction type, and ex-manufacturer price, is not available in the provided source documents.

Regulatory history

SEVIKAR 20/5, 20/10, 40/5, and 40/10 tablets were first listed on the ARTG on 14 May 2010.