Teveten, 600 mg 14 pcs

Pharmgroup:

An angiotensin II receptor blocker.

Pharmic action:

Epsartan is an angiotensin II receptor antagonist that binds selectively to AT1 receptors. Angiotensin II is the most active hormone of the renin-angiotensin-aldosterone system, which plays a leading role in the pathophysiology of arterial hypertension.

Angiotensin II binds to AT1 receptors in many tissues (e.g. vascular smooth muscle, adrenal glands, kidneys, heart) and causes important biological effects such as vasoconstriction, sodium retention and aldosterone release. Later angiotensin II is involved in the genesis of myocardial and vascular hypertrophy due to its action on myocardial and smooth muscle cell growth.

Eprosartan antagonistically inhibits the effects of angiotensin II on blood pressure, renal blood flow and aldosterone secretion in healthy subjects. In patients with arterial hypertension, sufficient control of blood pressure is achieved if the daily dose of Teveten® is taken in one dose or divided into two doses. Permanent and mild hypotensive effect is maintained for 24 h without the development of orthostatic arterial hypotension in response to the first dose. Discontinuation of treatment with Teveten® is not accompanied by a rapid rise in blood pressure as a type of withdrawal effect.

Lowering of blood pressure in patients with arterial hypertension does not cause changes in heart rate.

In patients with arterial hypertension, Teveten® has no effect on triglyceride, total cholesterol or LDL (low-density lipoprotein) cholesterol concentrations in blood. In addition, Teveten® has no effect on blood sugar levels.

The drug preserves renal function in patients with essential arterial hypertension and in patients with renal insufficiency. It does not decrease glomerular filtration rate in healthy men, in patients with arterial hypertension or renal insufficiency of various degrees of severity. Causes a natriuretic effect in healthy people on a hyponatremic diet. Teveten® can be administered without concern to patients with essential arterial hypertension and renal insufficiency of varying severity without expectation of sodium retention or impairment of renal function.

Teveten® has no significant effect on urinary excretion of uric acid.

Teveten® does not potentiate bradykinin-bound (and ACE-mediated) effects such as cough.

Indications

Arterial hypertension.

Active ingredient

Composition

How to take, the dosage

The drug is taken orally regardless of meals.

The recommended dose is 600 mg once daily in the morning. The initial dose does not need to be adjusted for elderly patients and patients with hepatic impairment.

In patients with severe or moderate renal insufficiency (creatinine clearance less than 60 ml/min), the daily dose should not exceed 600 mg.

The duration of use of Teveten is not limited.

Interaction

No clinically significant interaction of Teveten with other medicinal products was observed.

Digoxin, warfarin, glibenclamide – when used simultaneously, Teveten had no effect on the pharmacokinetics of digoxin and pharmacodynamics of warfarin, glibenclamide.

Ranitidine, ketoconazole, fluconazole – no changes in pharmacokinetic parameters of Teveten were observed with its concomitant use with ranitidine, ketoconazole, fluconazole.

Thiazide diuretics, slow calcium channel blockers – simultaneous use of Tevetin with thiazide diuretics (including hydrochlorothiazide), slow calcium channel blockers (including nifedipine) resulted in increased hypotensive effect, and no clinically significant adverse reactions are expected.

ACE inhibitors – concomitant use of ACE inhibitors with lithium preparations may lead to a reversible increase in the plasma concentration of lithium and an increased risk of its toxic effects. This interaction cannot be excluded also while using eprosartan (it is necessary to monitor carefully lithium concentration in patients receiving this combination).

Special Instructions

Use in renal dysfunction

In patients with severe or moderate renal impairment (CKR less than 60 ml/min), the daily dose should not exceed 600 mg.

The safety of Teveten administration in patients with terminal renal failure (CK (creatinine clearance) less than 5 ml/min, uremia II degree), as well as in patients on hemodialysis has not been established.

Before prescribing Tevetin to patients with renal insufficiency and periodically during the course, renal function should be monitored. If renal function deteriorates during this period, treatment should be reconsidered.

Particular indications

In decreased RBC, dehydration or electrolyte content (e.g., during treatment with high doses of diuretics, repeated vomiting, prolonged diarrhea, salt- and hyposalt-free diet) the drug administration may cause a sharp decrease of BP (symptomatic hypotension). Before prescribing Teveten such disorders should be eliminated.

Transient decrease in BP is not a reason to discontinue the drug, because in this case BP will stabilize with further administration.

In patients whose renal function depends on the activity of renin-angiotensin-aldosterone system (RAAS) (e.g., patients with severe heart failure, bilateral renal artery stenosis or artery stenosis of the sole kidney), oliguria and/or progressive azotemia and in rare cases, severe renal failure may develop during treatment with ACE inhibitors. Due to insufficient experience in the use of angiotensin II receptor antagonists in patients with severe heart failure or renal artery stenosis, renal dysfunction during Teveten administration due to RAAS suppression cannot be excluded.

Before prescribing Teveten to patients with renal insufficiency and periodically during the course, renal function should be monitored. If renal function deteriorates during this period, treatment should be reconsidered.

Tevetin can be used in combination with thiazide diuretics (including hydrochlorothiazide) and calcium channel blockers (including long-acting nifedipine); with hypolipidemic agents (including lovastatin, simvastatin, pravastatin, fenofibrate, gemfibrzil and nicotinic acid).

Impact on ability to drive vehicles and other mechanisms requiring increased concentration

Based on pharmacodynamic properties, eprosartan should not affect the ability to drive and use machines and mechanisms.

When treating arterial hypertension, caution should be exercised when driving motor vehicles and engaging in potentially hazardous activities that require increased concentration and rapid psychomotor reactions due to the potential for dizziness and weakness.

Contraindications

With caution: in severe heart failure (functional class III and IV according to the NYHA classification); with bilateral renal artery stenosis; with renal artery stenosis of the sole kidney; with decreased RBC due to vomiting, diarrhea, high-dose diuretics.

The safety of Teveten usage in patients with terminal renal insufficiency (creatinine clearance less than 5 ml/min, uremia II degree), as well as in patients on hemodialysis has not been determined.

Side effects

The overall incidence of side effects reported in patients taking eprosartan is comparable to that reported with placebo. These effects were generally mild and short-lived, so only 4.1% of patients treated with eprosartan in placebo-controlled trials needed to discontinue treatment (6.5% in the placebo group).

CNS disorders: rarely – headache, dizziness, asthenia.

Cardiovascular system disorders: very rarely – decrease of BP (including postural hypotension).

Dermatological reactions: rarely – rash, skin itching.

Allergic reactions: rare – urticaria; very rare – angioedema, facial edema.

Others: rare – cough.

Overdose

There are limited data on overdose in humans. The drug is well tolerated when taken orally. The efficacy of the drug in daily doses up to 1.2 g when taken for 8 weeks has been shown, and no dose dependence of the frequency of adverse effects has been found.

Symptoms: pronounced decrease in BP is most likely.

Treatment: conducting symptomatic therapy.

Pregnancy use

Teveten is contraindicated in pregnancy and during lactation.

If pregnancy is diagnosed, the drug should be stopped and the patient should be warned about the possible adverse effects.

Breastfeeding should be stopped if the drug has to be used during lactation.