Teveten plus, pills, 28pcs

Composition

1 film coated tablet contains:

• Active ingredients:
• Eprosartan mesylate – 735.8 mg, which corresponds to 600 mg of Eprosartan, hydrochlorothiazide-12.5 mg.
• Auxiliary substances:
• microcrystalline cellulose – 43.3 mg,
• lactose monohydrate-43.3 mg,
• pregelatinized corn starch-43.3 mg,
• crospovidone-38.5 mg, magnesium stearate-7.2 mg,
• purified water-50.9 mg.
• Shell:
• Opadry II Butterscotch 85F27320 – 39 mg (polyvinyl alcohol-15.60 mg, macrogol 3350-7.88 mg, talc-5.77 mg, titanium dioxide (E 171) – 9.41 mg, iron oxide yellow (E 172) – 0.33 mg, iron oxide black (E 172) – 0.004 mg).

Pharmacological action

Eprosartan angiotensin II receptor antagonist, selectively acts on ATI receptors located in the blood vessels, heart, kidneys and adrenal cortex, forms a strong connection with them with subsequent slow dissociation.

Prevents the development or weakens the effects of angiotensin II, inhibits the activity of the renin-angiotensin-aldosterone system (RAAS). It has vasodilating, hypotensive and indirect diuretic effects.

Reduces arterial vasoconstriction, total peripheral vascular resistance (OPSS), pressure in the small circle of blood circulation, water and sodium reabsorption in the proximal segment of the renal tubules, and aldosterone secretion. With prolonged use, it suppresses the proliferative effect of angiotensin II on vascular smooth muscle cells and myocardium.

The hypotensive effect after taking a single dose inside develops within 24 hours, and a stable therapeutic effect develops with regular oral use-after 2-3 weeks without affecting the heart rate (HR). It does not cause the development of orthostatic hypotension in response to the first dose of the drug.

Increases renal blood flow and glomerular filtration rate, reduces albumin excretion (nephroprotective effect), while maintaining renal self-regulation regardless of the severity of renal failure. It has no effect on lipid, carbohydrate and purine metabolism. When stopping treatment, it does not cause a “withdrawal” syndrome.

Less often than angiotensin converting enzyme (ACE) inhibitors, it causes bradykinin-related effects (including dry persistent cough).

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the mechanisms of electrolyte reabsorption in the renal tubule, increasing the volume of fluid release, sodium and chlorine.

Due to the diuretic effect of hydrochlorothiazide, the volume of blood plasma decreases, the activity of renin in the blood plasma increases, the secretion of aldosterone increases, which causes increased excretion of potassium and bicarbonates by the kidneys and a decrease in the content of potassium in the blood serum. The mechanism of antihypertensive action of hydrochlorothiazide is a combined diuretic and vasodilating effect.

Teveten PLUS in patients with elevated systolic blood pressure (BP) Eprosartan provides a statistically significant reduction in blood pressure. The addition of 12.5 mg hydrochlorothiazide to a single daily dose (600 or 1200 mg) of Eprosartan provides an additional statistically significant reduction in systolic blood pressure compared to the daily intake of Eprosartan alone.

Combined use of Eprosartan with hydrochlorothiazide reduces the potassium loss associated with the diuretic effect of hydrochlorothiazide. The diuretic effect of Teveten plus develops within the first 2 hours, and reaches a maximum-4 hours after ingestion.

Stable hypotensive effect develops, as a rule, after 2-3 weeks of treatment.

Pharmacokinetics

Eprosartan, when taken orally, has an absolute bioavailability of about 13%. The maximum concentration (Cmax) in blood plasma is determined after 1-2 hours. The binding to plasma proteins is high (98%) and remains constant after reaching the therapeutic concentration in blood plasma. The degree of binding to plasma proteins does not depend on the gender, age, or liver function of patients and does not change with moderate or minor renal insufficiency, but may decrease with severe renal insufficiency.

Practically does not accumulate.

The volume of distribution is 13 liters, the total clearance is 130 ml / min. When taken orally, it is mainly excreted unchanged-through the intestines (90%), by the kidneys (7%). A small part (less than 2%) is excreted by the kidneys in the form of glucuronides. In elderly patients, the values of Cmax and the area under the concentration-time curve (AUC) increase, on average, by 2 times, which, however, does not require dose adjustment, since it has no clinical significance.

In hepatic insufficiency, the AUC values increase, on average, by about 40%, which does not require dose adjustment and has no clinical significance.

In patients with moderate chronic renal failure (CRF) (creatinine clearance from 30 to 59 ml/min), AUC and Cmax were 30% higher, and in those with severe CRF (creatinine clearance from 5 to 29 ml/min) – 50% higher than in healthy volunteers. The pharmacokinetics of Eprosartan do not differ in male and female patients.

Hydrochlorothiazide is not metabolized and is rapidly excreted by the kidneys. At least 61% of the oral dose is excreted unchanged within 24 hours. It does not cross the blood-brain barrier, but it does cross the placental barrier and is excreted in breast milk.

Teveten PLUS Simultaneous use of Eprosartan and hydrochlorothiazide does not have a clinically significant effect on the pharmacokinetics of both components. Food intake does not affect the bioavailability of Eprosartan and hydrochlorothiazide, but delays their absorption. Maximum plasma concentrations are reached 4 hours after taking Eprosartan and 3 hours after taking oral hydrochlorothiazide.

Indications

Arterial hypertension (in monotherapy or in combination with other antihypertensive agents).

Contraindications

• Hypersensitivity to Eprosartan, hydrochlorothiazide and other sulfonamide derivatives and other components of the drug.
• Pregnancy and lactation.
• Severe renal insufficiency (creatinine clearance less than 30 ml / min).
• Age up to 18 years (efficacy and safety have not been established).
• Hemodynamically significant bilateral renal artery stenosis and single kidney artery stenosis.
• Rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome (the drug contains lactose).

With caution, severe chronic heart failure (NYHA functional Class IV); bilateral renal artery stenosis, single kidney artery stenosis, decreased circulating blood volume (BCC), impaired blood water and electrolyte balance (due to high doses of diuretics, repeated vomiting, prolonged diarrhea, salt-free diet), moderate or severe liver dysfunction, diabetes mellitus.

There is no clinical experience of using Teveten plus in the treatment of patients with severe hepatic impairment.

Side effects

The overall incidence of adverse events reported in patients taking Eprosartan is comparable to that of placebo. These effects were generally mild and short-lived, so that discontinuation of treatment was required in only 4.1% of patients taking Eprosartan in placebo-controlled clinical trials (6.5% in the placebo group).

From the central nervous system: rarely-headache, dizziness, asthenia.

From the cardiovascular system: very rarely — a decrease in blood pressure, including postural hypotension.

From the skin and subcutaneous fat: rarely-skin reactions (rash, pruritus and urticaria); very rarely-facial edema, angioedema.

Other: rarely-cough.

Interaction

The antihypertensive effect may increase when used concomitantly with other antihypertensive agents.

When used together with oral hypoglycemic agents, it is necessary to adjust their dose, since hydrochlorothiazide can reduce glucose tolerance.

When used concomitantly with lithium preparations, a reversible increase in the concentration of lithium in blood plasma and an increased risk of its toxic effects may occur (careful monitoring of lithium concentrations is necessary in patients receiving this combination).

NSAIDs may reduce the diuretic and hypotensive effects of Teveten Plus.

By lowering potassium levels, hydrochlorothiazide can enhance the effects of cardiac glycosides and certain antiarrhythmic medications.

Hydrochlorothiazide increases the risk of hypokalemia when administered together with drugs that cause the body to lose potassium, for example, with diuretics that have a kaliuretic effect, laxatives, corticosteroids and ACTH.

Hydrochlorothiazide can enhance the effect of non-depolarizing muscle relaxants (for example, tubocurarin). Absorption of hydrochlorothiazide is reduced by co-use of anion exchange resins (for example, colestyramine or colestipol).

How to take it, course of use and dosage

Teveten Plus is taken orally,1 tablet each. per day, in the morning, regardless of food intake.

Dose adjustment of Teveten Plus is not required in elderly patients, patients with mild to moderate hepatic impairment, or patients with impaired renal function (creatinine clearance greater than 30 ml / min).

Overdose

There are currently no data on overdose of Teveten plus.Among the symptoms, it is possible to assume the following: excessive decrease in blood pressure, dehydration and electrolyte imbalance (hypokalemia, hypochloremia, hyponatremia), manifested in the form of nausea and drowsiness.

Treatment Depending on the time elapsed after a meal, measures taken should include inducing vomiting, gastric lavage, and / or taking activated charcoal.

With a sharp decrease in blood pressure, it is recommended to lay the patient on his back, raise his legs, and, if necessary, introduce plasma-substituting fluids. Symptomatic and supportive therapy is recommended for dehydration and impaired water-salt balance. Hemodialysis is not effective.

Special instructions

Based on the pharmacodynamic properties, Teveten Plus should not affect the ability to drive a car and use machines and mechanisms.

During the treatment of hypertension, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, due to the fact that dizziness and weakness may occur.

Form of production

Coated tablets.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Eprosartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension