Description
Pharmacological action
Combined antihypertensive drug (angiotensin II receptor antagonist + diuretic) Telpres Plus is a combination of telmisartan (angiotensin II receptor antagonist) and hydrochlorothiazide – thiazide diuretic. The simultaneous use of these components leads to a more pronounced antihypertensive effect than the use of each of them separately. Taking Telpres Plus once a day leads to a significant gradual decrease in blood pressure (BP).
Indications
Arterial hypertension (in case of inefficiency of telmisartan or hydrochlorothiazide in monotherapy)
Contraindications
Hypersensitivity to active ingredients or auxiliary components of the drug or other sulfonamide derivatives Pregnancy Breastfeeding period Obstructive diseases of the biliary tract Severe hepatic impairment (class C according to Child Pugh classification) Severe renal impairment (ml) 30 min Refractory hypokalemia, hypercalcemia Concomitant use with aliskiren in patients with diabetes mellitus and / or impaired renal function (cl barrel filtration of less than 60 ml / min / 1.73 m2) The simultaneous use of ACE inhibitors in patients with diabetic nephropathy lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome Age 18 years (efficacy and safety have not been established).
Special instructions
Liver dysfunction
The use of Telpres Plus is contraindicated in patients with cholestasis, biliary obstruction or severe liver dysfunction (Child-Pu classification class C) (see Contraindications section, since telmisartan is mainly excreted . It is believed that in such patients, hepatic clearance of telmisartan is reduced. In patients with mild or moderate hepatic impairment (Child-Pugh class A and B classification), Telpres Plus should be used with caution (see section Precautions).
Renovascular hypertension
In the treatment of drugs acting on RAAS, especially after the first administration of Telpres Plus, it may occur in patients with a low BCC and / or sodium content in blood plasma against the background of previous treatment with diuretics, restriction of salt, diarrhea or vomiting. Such conditions (fluid and / or sodium deficiency) should be eliminated before taking Telpres Plus.
Double blockade of the renin-angiotensin-aldosterone system
The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal failure (glomerular filtration rate less than 60 ml / min / 1.73 m2) (see section Contraindications).
The simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy (see section Contraindications).
As a result of the oppression of the RAAS, the following were noted:
Primary aldosteronism
In patients with primary aldosteronism, treatment with antihypertensive drugs, which are carried out by inhibiting RAAS, is usually ineffective.
Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy
Caution should be exercised when using Telpres Plus (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy.
Acute myopia and secondary angle-closure glaucoma
Hydrochlorothiazide, a derivative of sulfonamide, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma.
Primary aldosteronism
In patients with primary aldosteronism, treatment with antihypertensive drugs, which are carried out by inhibiting RAAS, is usually ineffective.
Aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy
care must be taken when using Telpres Plus (as well as other vasodilators) in patients with aortic or mitral stenosis, as well as hypertrophic obstructive cardiomyopathy.
Acute myopia and secondary angle-closure glaucoma
Hydrochlorothiazide, a derivative of sulfonamide, can cause an idiosyncratic reaction in the form of acute transient myopia and acute angle-closure glaucoma. Symptoms of these disorders are an unexpected decrease in visual acuity or eye pain, which in typical cases occurs within a few hours to several weeks after the start of the drug. If untreated, acute angle-closure glaucoma can lead to vision loss. The main treatment is to discontinue hydrochlorothiazide as quickly as possible. It must be borne in mind that if intraocular pressure remains uncontrolled, urgent conservative or surgical treatment may be required. Risk factors for the development of acute angle-closure glaucoma include a history of allergies to sulfonamides or penicillin.
Composition
1 tab. hydrochlorothiazide 12.5 mg telmisartan 80 mg Excipients: mannitol – 327.7 mg, povidone K25 – 21.6 mg, crospovidone – 12 mg, magnesium stearate – 8.5 mg, meglumine – 24 mg, sodium hydroxide – 6.7 mg, lactose monohydrate – 49.84 mg, microcrystalline cellulose – 32 mg, hypromellose – 3 mg, sodium carboxymethyl starch (type A) – 2 mg, yellow iron oxide (E172) – 0.17 mg.
Dosage and administration
Inside, regardless of the meal time.
The drug Telpres Plus must be taken once a day.
Telpres Plus 12.5 / 40 mg may be prescribed to patients in whom the use of telmisartan preparations in a dosage of 40 mg or hydrochlorothiazide does not lead to adequate control of blood pressure.
Telpres Plus 12.5 / 80 mg may be prescribed to patients in whom the use of telmisartan preparations in a dosage of 80 mg or Telpres Plus 12.5 / 40 mg does not lead to adequate control of blood pressure.
Telpres Plus 25/80 mg may be prescribed to patients in whom the use of telmisartan preparations in a dosage of 80 mg or Telpres Plus 12.5 / 80 mg does not lead to adequate control of blood pressure, or to patients the condition of which was previously stabilized by telmisartan or hydrochlorothiazide when used separately.
In patients with severe arterial hypertension, the maximum daily dose of telmisartan is 160 mg in combination with hydrochlorothiazide in a daily dose of 12.5-25 mg.
Impaired renal function
Limited experience with Telpres Plus in patients with mild to moderate renal impairment does not require dose changes in these cases. In such patients, renal function should be monitored (with CC less than 30 ml / min, see section “Contraindications”).
Impaired liver function
In patients with mild to moderate impaired liver function (Child-Pugh Class A and B), the daily dose of Telpres Plus should not exceed 12.5 / 40 mg per day (see section “Pharmacokinetics”).
Elderly patients
Dosage regimen does not require changes.
Overdose
Information on overdose is limited. Possible symptoms of an overdose are composed of symptoms from the individual components of the drug. Telmisartan – the most significant – a pronounced decrease in blood pressure and tachycardia, bradycardia, dizziness, increased serum creatinine concentration and acute renal failure may also occur. Hydrochlorothiazide is a violation of the water-electrolyte balance of the blood (hypokalemia, hypochloremia), a decrease in BCC, which can lead to muscle spasms and / or increase disorders of the cardiovascular system: arrhythmias caused by the simultaneous use of cardiac glycosides or some antiarrhythmic drugs. Treatment: symptomatic therapy, hemodialysis is ineffective. The degree of removal of hydrochlorothiazide during hemodialysis has not been established. Regular monitoring of serum electrolytes and creatinine is required. Hemodialysis is not effective.
Storage conditions
At a temperature not exceeding 25 ° C, in the original packaging.
Keep out of the reach of children!
Shelf life
2 years.
Active ingredient
Hydrochlorothiazide, Telmisartan
Conditions of supply of pharmacies
Prescription
lekarstvennaja form
tablets
