Twentieth - instructions for use, reviews, analogs and formulations (tablets 5 + 40 mg, 5 + 80 mg, 10 + 40 mg, 10 + 80 mg) of the drug for the treatment of hypertension and pressure reduction in adults, children and pregnancy. Composition and alcohol

In this article, you can read the instructions for using the drug Twente. There are reviews of visitors to the site - consumers of this medication, as well as opinions of specialists in the use of Twiste in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Twins in the presence of existing structural analogues. Use to treat hypertension and reduce pressure in adults, children, as well as during pregnancy and lactation.Composition and interaction of the drug with alcohol.

Twente - a combined preparation containing two antihypertensive substances with a complementary effect that allows controlling blood pressure in patients with arterial (essential) hypertension: an angiotensin 2 receptor antagonist, telmisartan, and a slow calcium channel blocker, a dihydropyridine derivative, amlodipine. The combination of these substances has an additive antihypertensive effect, reducing arterial pressure more than each individual component. Twist drug, taken once a day, leads to an effective and sustained reduction of blood pressure within 24 hours.

Telmisartan

Telmisartan is a specific angiotensin 2 receptor antagonist (type AT1), effective when ingested. Has a high affinity for the AT1 receptor subtype of angiotensin 2, through which the action of angiotensin 2 is realized. It displaces angiotensin 2 from its binding to the receptor without having an agonist action against this receptor. Telmisartan binds only to the AT1 receptor subtype of angiotensin 2. Communication is of a lasting nature. Does not have an affinity for other receptors, incl. to the AT2 receptor.Reduces the concentration of aldosterone in the blood, does not inhibit renin in the blood plasma and does not block the ion channels. Telmisartan does not inhibit the angiotensin-converting enzyme (ACE, kininase 2) (an enzyme that also breaks down bradykinin). Therefore, the enhancement of bradykinin-induced side effects is not expected. The effect of the drug persists for 24 hours and remains significant until 48 hours. The pronounced antihypertensive effect usually develops 4-8 weeks after regular administration. In the case of a sharp withdrawal of telmisartan, blood pressure gradually returns to the baseline without the development of withdrawal syndrome.

Amlodipine

Amlodipine - a derivative of dihydropyridine, belongs to the class of blockers of slow calcium channels. It inhibits transmembrannoe intake of calcium ions in cardiomyocytes and smooth muscle cells of blood vessels. The mechanism of antihypertensive action of Amlodipine is associated with a direct relaxing effect on the smooth muscle cells of the vessels, which leads to a decrease in peripheral vascular resistance and a decrease in blood pressure.

In patients with arterial hypertension, the use of amlodipine 1 time per day provides a clinically significant decrease in blood pressure during 24 hours.

Orthostatic arterial hypotension is not characteristic during the application of amlodipine due to the slow onset of the drug. In patients with arterial hypertension and normal renal function, amlodipine in therapeutic doses reduced the resistance of the kidney vessels, increased glomerular filtration rate and the effective blood flow in the kidneys, without altering the filtration or proteinuria.

Amlodipine does not lead to any metabolic adverse effects or changes in plasma lipids, and is therefore suitable for use in patients with bronchial asthma, diabetes and gout. The use of amlodipine in patients with heart failure is not accompanied by a negative inotropic effect (exercise tolerance does not decrease, the left ventricular ejection fraction does not decrease).

Composition

Amlodipine besylate + Telmisartan + excipients.

Pharmacokinetics

Telmisartan

When ingested quickly absorbed from the digestive tract. Bioavailability - 50%. After 3 hours after ingestion, the concentration in the blood plasma levels out, regardless of food intake.Metabolized telmisartan by conjugation with glucuronic acid. Metabolites are pharmacologically inactive. It is excreted through the intestine in unchanged form, excretion by the kidneys of less than 2%.

Amlodipine

Eating food does not affect the bioavailability of amlodipine. Studies have shown that in patients with hypertension, approximately 97.5% of circulating amlodipine binds to plasma proteins. Amlodipine is metabolized to a significant extent (approximately 90%) in the liver with the formation of inactive metabolites. Amlodipine is excreted by the kidneys both in unchanged form (10%) and in the form of metabolites (60%).

Pharmacokinetics in special clinical cases

There is a difference in plasma concentrations in men and women.

The pharmacokinetics of telmisartan in elderly patients does not differ from young patients. Dose correction is not required.

Indications

• arterial hypertension (for patients whose blood pressure is not adequately controlled by telmisartan or amlodipine in monotherapy);
• arterial hypertension (for patients who are shown combined therapy);
• patients with arterial hypertension receiving telmisartan and amlodipine as separate tablets, as a substitute for this therapy.

Forms of release

Tablets 5 + 40 mg, 5 + 80 mg, 10 + 40 mg, 10 + 80 mg.

Instructions for use and dosage

Adults

The drug Twist must be taken 1 time per day, inside, regardless of food intake.

Twentieth can be given to patients receiving the same doses of telmisartan and amlodipine in separate tablets, for the convenience of therapy and increased adherence to treatment.

Twentieth can be given to patients in whom the use of one amlodipine or one telmisartan does not lead to adequate control of blood pressure. Patients taking amlodipine at a dose of 10 mg who have adverse drug-limiting reactions, such as peripheral edema, may switch to taking Twinst at a dose of 40/5 mg once a day, which will reduce the dose of amlodipine, but not reduce the total expected antihypertensive effect.

Treatment of arterial hypertension in a patient can begin with the use of Twist's drug in the event that it is unlikely that it is unlikely to achieve BP control with any single drug. The usual initial dose of Twinst is 40/5 mg once a day. Patients who need a more significant reduction in blood pressure can start taking Twann's drug at a dose of 80/5 mg once a day.

If, at least after 2 weeks of treatment, an additional reduction in blood pressure is required, the dose of the drug can be gradually increased to a maximum dose of 80/10 mg once a day.

Twinsta can be used together with other antihypertensive drugs.

Elderly patients

Dosing regimen does not require any changes.

Features of the drug during the first admission or when it is canceled

After the first dose of telmisartan, the hypotensive effect gradually develops during the first 3 hours and the effect of the drug persists for 24 hours and remains significant until 48 hours.

In the case of a sharp withdrawal of telmisartan, blood pressure gradually returns to the baseline without the development of withdrawal syndrome.

Side effect

• cystitis;
• urinary tract infections;
• upper respiratory tract infection;
• sepsis, incl. with lethal outcome;
• depression;
• anxiety;
• insomnia;
• mood lability;
• confused consciousness;
• dizziness;
• drowsiness;
• migraine;
• headache;
• paresthesia;
• a taste disorder;
• fainting;
• tremor;
• peripheral neuropathy;
• anaphylactic reaction;
• impaired vision;
• vertigo;
• noise in ears;
• bradycardia;
• a feeling of palpitations;
• tachycardia;
• myocardial infarction;
• arrhythmia;
• ventricular tachycardia;
• atrial fibrillation;
• orthostatic hypotension;
• cough;
• dyspnea;
• rhinitis;
• abdominal pain;
• diarrhea;
• nausea, vomiting;
• flatulence;
• pancreatitis;
• gastritis;
• hepatitis;
• jaundice;
• eczema;
• rash;
• itching;
• angioedema;
• hyperhidrosis;
• hives;
• alopecia;
• erythema multiforme;
• exfoliative dermatitis;
• Stevens-Johnson syndrome;
• photosensitivity reaction;
• vasculitis;
• arthralgia;
• backache;
• muscle spasms (cramps of the calf muscles);
• myalgia;
• disturbances of urination;
• frequent urination;
• erectile disfunction;
• peripheral edema;
• asthenia (weakness);
• increased fatigue;
• influenza-like syndrome;
• the feeling of a rush of blood to the face;
• dryness of the oral mucosa;
• increase in body weight;
• decrease in body weight;
• gynecomastia;
• thrombocytopenia.

Contraindications

• obstructive diseases of the biliary tract;
• severe arterial hypotension;
• obstruction of the outgoing tract of the left ventricle (including a high degree of aortic stenosis);
• hemodynamically unstable heart failure after acute myocardial infarction;
• severe hepatic impairment;
• shock;
• fructose intolerance and glucose / galactose absorption disorder or sugarase / isomaltase deficiency;
• pregnancy;
• the period of breastfeeding;
• age under 18 years (effectiveness and safety not established);
• hypersensitivity to active components or excipients;
• hypersensitivity to other dihydropyridine derivatives.

The drug should be administered with caution to patients with:

• obstructive biliary tract disease or liver failure;
• bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney;
• condition after kidney transplantation;
• decreased bcc and / or hyponatraemia;
• double blockade of the renin-angiotensin-aldosterone system (RAAS);
• other states characterized by activation of RAAS;
• primary aldosteronism;
• stenosis of the aortic and mitral valve, obstructive hypertrophic cardiomyopathy;
• heart failure;
• hyperkalemia;
• diabetes mellitus with an additional cardiovascular risk (i.e., concomitant coronary artery disease (coronary heart disease - ischemic heart disease));
• after 1 month after acute myocardial infarction and unstable angina.

Application in pregnancy and lactation

Special studies of the Twinst drug during pregnancy and during lactation were not conducted. Effects associated with individual components of the drug are described below.

Pregnancy

Telmisartan

The use of angiotensin 2 receptor antagonists (APA 2) is contraindicated during pregnancy. When diagnosing pregnancy, the drug should be stopped immediately. If necessary, alternative therapy should be prescribed.

It is known that the use of APA 2 during the 2nd and 3rd trimesters of pregnancy has a fetotoxic effect (decreased kidney function, oligohydramnion, slowing ossification of the fetal skull), and neonatal toxicity (kidney failure, arterial hypotension and hyperkalemia) is observed.

Amlodipine

Available limited data on the effects of amlodipine or other calcium receptor antagonists do not indicate a negative effect on the fetus. However, there is a risk of slowing the delivery process.

Breastfeeding period

Special studies on the isolation of telmisartan and / or amlodipine in breast milk have not been conducted in women. Animal studies have shown that telmisartan is excreted with the milk of lactating animals. Taking into account possible adverse reactions, the decision to continue breastfeeding or to abolish therapy should be made taking into account its importance for the mother. Studies of the impact on human fertility have not been conducted.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety not established).

Application in elderly patients

Dosing regimen does not require any changes.

special instructions

The drug should be administered with caution if the patient has the following conditions:

• abnormal liver function;
• bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, severe renal dysfunction. In some patients, due to the suppression of RAAS, especially when using a combination of agents acting on this system, renal function (including acute renal failure) is impaired. Therefore, therapy, accompanied by such a double blockade of RAAS,should be carried out strictly individually and with careful monitoring of kidney function (including periodic monitoring of potassium and creatinine in the blood serum). In cases of vascular tone and kidney function, mainly from RAAS activity (for example, in patients with chronic heart failure or kidney disease, including renal artery stenosis, or stenosis of the single kidney artery), the administration of drugs that affect this system, may be accompanied by the development of acute arterial hypotension, hyperaemia, oliguria, and, in rare cases, acute renal failure;
• condition after kidney transplantation (no experience of application);
• decreased BCC and / or hyponatremia due to previous diuretic therapy, restriction of salt intake, diarrhea, or vomiting;
• double blockade of RAAS;
• Other states characterized by activation of the RAAS;
• primary aldosteronism;
• stenosis of the aortic and mitral valve, idiopathic hypertrophic subaortic stenosis;
• heart failure;
• hyperkalemia;
• hereditary intolerance to fructose;
• in patients with diabetes mellitus and an additional cardiovascular risk, i.e. Patients with diabetes mellitus and associated coronary artery disease (CAD) risk of fatal myocardial infarction and sudden cardiovascular death may be increased in the treatment of antihypertensive agents such as angiotensin receptor 2 antagonists and ACE inhibitors. In patients with diabetes mellitus CHD may occur symptomless, whereby not be diagnosed. Patients with diabetes must receive appropriate diagnosis, for example, exercise tests, for diagnosing and treating coronary artery disease, respectively, before treatment with Tvinsta.

Other instructions

Tvinsta less effective in the treatment of patients blacks (in this population typically reduced activity of renin in the blood).

There are no data on the use of the drug Tvinsta in patients with unstable angina, acute myocardial infarction and in the period of one month after myocardial infarction.

Impact on the ability to drive vehicles and manage mechanisms

Studies of the impact on the ability to drive vehicles and control mechanisms have not been conducted.However, it should be appreciated that during treatment, undesirable effects such as syncope, drowsiness, or dizziness may be noted. Therefore, during the management of vehicles or mechanisms should be careful. If patients experience these feelings, they should avoid performing potentially dangerous activities, such as driving vehicles or controlling mechanisms.

Drug Interactions

Interactions between the two active components, which are fixed doses in the composition of this drug, were not observed in clinical studies.

Special studies of drug interactions between Twist and other drugs have not been conducted.

Combination of active components

If the drug Twist is used concomitantly with the following drugs, the following information should be taken into account.

Other antihypertensive drugs

With simultaneous use with other antihypertensive drugs, the antihypertensive effect of Twist's drug can be enhanced.

Drugs capable of lowering blood pressure

It can be expected that some drugs, for example, Baclofen and amifostine, due to their pharmacological properties, will enhance the antihypertensive effect of all antihypertensive drugs, including Twist. In addition, orthostatic hypotension can be enhanced by ethanol (alcohol), barbiturates, narcotics or antidepressants.

Corticosteroids (systemic application)

It is possible to reduce the hypotensive effect.

Telmisartan

With the simultaneous use of telmisartan with:

• other antihypertensive drugs: possibly strengthening the hypotensive effect. In one study, combined use of telmisartan and ramipril increased the AUC0-24 and Cmax ramipril and ramiprilata by 2.5 times. The clinical significance of this interaction is not established.
• digoxin, warfarin, hydrochlorothiazide, glibenclamide, simvastatin and amlodipine: no clinically significant interaction was found. An increase in the average concentration of digoxin in the blood plasma was observed on average by 20% (in one case by 39%). With the simultaneous administration of telmisartan and digoxin, it is advisable to periodically determine the concentration of digoxin in the blood.
• lithium preparations: there was a reversible increase in the concentration of lithium in the blood, accompanied by toxic effects when taking ACE inhibitors. In rare cases, such changes were registered with the appointment of angiotensin 2 receptor antagonists, in particular telmisartan. At simultaneous appointment of lithium preparations and angiotensin 2 receptor antagonists, it is recommended to determine the content of lithium in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid in doses used as an anti-inflammatory agent, cyclooxygenase-2 (COX-2) inhibitors and nonselective NSAIDs, can cause acute renal failure in patients with reduced BCC. Drugs affecting the activity of the renin-angiotensin system, incl. telmisartan, may have a synergistic effect. In patients receiving NSAIDs and telmisartan, the beginning of treatment should be compensated for BCC and kidney function monitoring.

With the simultaneous use of NSAIDs and antihypertensive drugs like telmisartan, a reduction in the hypotensive effect was reported by inhibiting the vasodilating effect of prostaglandins.

Amlodipine

With the simultaneous use of amlodipine with:

• grapefruit and grapefruit juice: the simultaneous use of the drug with grapefruit or grapefruit juice is not recommended, tk. In some patients, as a result of increasing the bioavailability of amlodipine, its antihypertensive effects may increase.
• inhibitors of the isoenzyme CYP3A4: in a study in elderly patients, it was shown that diltiazem inhibits the metabolism of amlodipine, probably influencing CYP3A4 (amlodipine concentrations in the blood plasma increase by approximately 50% and amplify the effect of amlodipine). It can not be ruled out that more active inhibitors of CYP3A4 (such as ketoconazole, itraconazole, ritonavir) can increase the concentration of amlodipine in the blood plasma more than diltiazem.
• inducers of the isoenzyme CYP3A4 - anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin, phosphenytoin, primidone), rifampicin, Hypericum perforatum: joint use can lead to a decrease in the concentration of amlodipine in the blood plasma. Regular medical supervision is shown. During the application of inducers CYP3A4, and also after their cancellation, it is recommended (if possible) a change in the dose of amlodipine.
• the simultaneous use of simvastatin 80 mg with amlodipine, regardless of dose, promotes an increase in the exposure of simvastatin up to 77% compared with simvastatin monotherapy. Therefore, the dose of simvastatin should not exceed 40 mg per day.

If the following drugs are used concomitantly, the following information should be taken into account

The safety of joint use of amlodipine with thiazide diuretics, beta-adrenoblockers, ACE inhibitors, long-acting nitrates, Nitroglycerin (used sublingually), NSAIDs, antibiotics and hypoglycemic agents for oral administration has been established.

With the simultaneous use of amlodipine and sildenafil, it was shown that each drug had an independent hypotensive effect.

Additional Information

Simultaneous use in 20 healthy volunteers of 240 ml of grapefruit juice with a single dose of amlodipine 10 mg ingested did not significantly affect the pharmacokinetic properties of amlodipine.

The simultaneous use of amlodipine with cimetidine did not significantly affect the pharmacokinetics of amlodipine.

The simultaneous use of amlodipine with atorvastatin, digoxin, Warfarin or cyclosporine did not significantly affect the pharmacokinetics or pharmacodynamics of these drugs.

Based on the experience of using other agents that affect RAAS, the simultaneous use of Twist and potassium-sparing diuretics, potassium-containing supplements, potassium-containing dietary salt, other potassium-increasing agents (eg, heparin), may lead to hyperkalemia, therefore, this indicator should be monitored in patients. In this regard, their simultaneous use with telmisartan requires caution.

Analogues of Twist's drug

There are no structural analogs to the active substance of Twist's medicine.

Analogues on the curative effect (means for the treatment of hypertension):

• Adelphan;
• Altiazem PP;
• Amlodipine;
• Anaprilin;
• Arifon;
• Atenolol;
• Berlipril;
• Betalk;
• Vasotensis;
• Walsakor;
• Verapamil;
• Veroshpiron;
• Hypothiazide;
• Dibazol;
• Diltiazem;
• Diroton;
• Doxazosin;
• The Zocardis;
• Indap;
• Indapamide;
• Kalchek;
• Kapoten;
• Captopril;
• Carvedilol;
• Cardura;
• Clopheline;
• Co-Diroton;
• Korenitec;
• Concor;
• Corvitol;
• Cordaflex;
• Cordipine;
• Corinfar;
• Kornam;
• Cristepin;
• Qudesan;
• Lasix;
• Lysinopril;
• Liprimar;
• Lozap;
• Lorist;
• Metoprolol;
• Nifedipine;
• Nifecard;
• Nicergoline;
• Noliprel;
• Obsidan;
• Platyphylline;
• Prestan;
• Prestarium;
• Propranolol;
• Raunatin;
• Renipril;
• Spironolactone;
• Physiotherapy;
• Fosicard;
• Furosemide;
• Hartil;
• Egilok;
• Exforge;
• Enalapril;
• Enap;
• Enziks.

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