Sevikar tablets are used for the following indications:
Treatment of essential hypertension. Sevikar is indicated in patients in whom olmesartan medoxomil or amlodipine monotherapy does not provide adequate blood pressure control.
Composition
Active ingredient: olmesartan medoxomil; amlodipine besylate.
1 film-coated tablet contains olmesartan medoxomil 20 mg, amlodipine besylate 6.944 mg, equivalent to amlodipine 5 mg.
Excipients: pregelatinized corn starch, silicified microcrystalline cellulose (contains 98% microcrystalline cellulose (Ph. Eur.) and 2% colloidal anhydrous silicon dioxide (Ph. Eur.)), croscarmellose sodium, magnesium stearate (vegetable origin).
The film coating contains: Opadry II 85F18422 white or Opadry II 85F22093 yellow, or Opadry II 85F25467 red (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc, iron oxide yellow (E 172), iron oxide red (E 172)).
Contraindication
Hypersensitivity to the active substances, dihydropyridine derivatives or any of the excipients.
Pregnancy and planning pregnancy. Severe hepatic impairment and biliary obstruction. The concomitant use of Sevikar and aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
Due to the presence of amlodipine, Sevikar is also contraindicated in patients who:
severe arterial hypotension; shock (including cardiogenic shock); impaired outflow of blood from the left ventricle (for example, with severe aortic stenosis); hemodynamically unstable heart failure after acute myocardial infarction.
Method of application
The recommended dose of Sevikar is 1 tablet per day.
Sevikar 20/5 can be prescribed to patients with an insufficient response to monotherapy with olmesartan medoxomil at a dose of 20 mg or amlodipine at a dose of 5 mg.
Sevikar 40/5 can be prescribed to patients with an insufficient body response to Sevikar 20/5.
Sevikar 40/10 can be prescribed to patients with an insufficient body response to Sevikar 40/5.
Before prescribing a combination drug with fixed doses of the active ingredients, it is recommended to gradually select the doses of these components as monodrugs. If necessary, direct replacement of monodrugs with a combination drug is possible.
For convenience, patients receiving olmesartan medoxomil and amlodipine as separate tablets may be switched to Sevikar tablets containing these components in similar doses.
Sevikar can be taken regardless of meals.
Features
Pregnant women
Contraindicated.
Children
Data is missing.
Drivers
Sevikar may have minor or moderate influence on the ability to drive and use machines.
Overdose
There have been no reports of overdose with Sevikar. The most likely effects of olmesartan medoxomil overdose are hypotension and tachycardia; bradycardia may also occur with parasympathetic (vagus nerve) stimulation. Overdose with amlodipine may result in excessive peripheral vasodilation, with marked hypotension and possibly reflex tachycardia. There have been reports of prolonged severe generalized hypotension, up to and including shock with fatal outcome.
Side effects
The most common adverse reactions occurring during the use of Sevikar were peripheral edema (11.3%), headache (5.3%), and dizziness (4.5%).
Interaction
The hypotensive effect of Sevikar may be enhanced by concomitant use of other antihypertensive drugs (e.g. alpha-blockers, diuretics).
Storage conditions
Does not require special storage conditions.
Keep out of reach of children.
Shelf life: 5 years.
