Sevikar NST tablets are used to treat essential hypertension:
add-on therapy (prescribed to patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine as a two-component drug); replacement therapy (prescribed as alternative therapy to adult patients whose blood pressure is normally controlled with the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide as two-component drugs (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and single-component drugs (hydrochlorothiazide or amlodipine).
Composition
One film-coated tablet contains (active ingredients):
olmesartan medoxomil 20 mg; amlodipine besylate - 6.944 mg, which is equivalent to amlodipine - 5 mg; hydrochlorothiazide 12.5 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); film coating contains: Opadry II 85F24118 or Opadry II 85F32331, or Opadry II 85F25437 (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E 172)).
Contraindication
hypersensitivity to the active substances, to dihydropyridine derivatives or to sulfonamides (since hydrochlorothiazide is a sulfonamide drug) or to any of the excipients; severe renal impairment; persistent hypokalemia, hypercalcemia, hyponatremia and clinically pronounced hyperuricemia; severe hepatic impairment, cholestasis and obstructive bile duct diseases; II and III trimesters of pregnancy; combined use of the drug "Sevikar NST" and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml / minute / 1.73 m 2); Due to the content of amlodipine as an active ingredient in the drug, the drug "Sevikar NST" is contraindicated in patients with: shock (including cardiogenic shock), severe hypotension, impaired blood outflow from the left ventricle (for example, severe aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction.
Method of application
Sevikar NST tablets are taken once a day, regardless of meals.
The tablet should be taken with a sufficient amount of liquid (e.g. a glass of water). The tablet should not be chewed. The drug should be taken at the same time every day.
Additional therapy
The drug can be used in patients whose blood pressure is not sufficiently controlled with olmesartan medoxomil 20 mg and amlodipine 5 mg in a two-component combination.
Before switching to a triple combination, gradual titration of the individual components is recommended. If clinically appropriate, direct substitution of a two-component combination with a three-component combination may be considered.
Replacement therapy
Patients who are taking stable doses of olmesartan medoxomil, amlodipine and hydrochlorothiazide simultaneously as a two-component drug (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single-component drug (hydrochlorothiazide or amlodipine) can switch to Sevikar HCT, which contains the same doses of the components.
The maximum dose of the drug "Sevikar NST" is 40 mg / 10 mg / 25 mg per day.
Application features
Pregnant women
The use of the drug "Sevikar NST" is contraindicated during the II and III trimesters of pregnancy. Given the effect of the active substances in the combined drug "Sevikar NST" on pregnancy, the use of the drug is not recommended during the first trimester of pregnancy.
Since there is no information on the use of the drug during breastfeeding, Sevikar NST is not recommended for use in breastfeeding women.
There have been reports of reversible biochemical changes in the head of spermatozoa in some patients taking calcium channel blockers. Clinical data on the potential effect of amlodipine on fertility are insufficient. In a study in rats, adverse effects on male fertility were observed.
Children
Sevikar NST is not recommended for use in children and adolescents (under 18 years of age) due to insufficient data on safety and efficacy.
Drivers
No studies have been conducted on the effect on the reaction rate when driving vehicles or using other mechanisms. However, it should be borne in mind that patients undergoing antihypertensive therapy may occasionally experience dizziness, headache, nausea or fatigue, which may impair their reaction. Caution is recommended, especially at the beginning of treatment.
Overdose
Symptoms
There is no information on overdose of Sevikar NST in humans. The most likely effect of overdose is hypotension.
Treatment
In the event of an overdose of Sevikar HCT, treatment is symptomatic and supportive and depends on the time elapsed since ingestion and the severity of symptoms. If ingestion was recent, gastric lavage may be considered.
During treatment with Sevikar NST, the most commonly reported adverse reactions are: peripheral edema, headache, and dizziness.
Storage conditions
Keep out of reach of children. No special storage conditions required.
Shelf life - 3 years.
