Hydrochlorothiazide, Telmisartan

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Dosage and Administration

Adverse reactions

1) Expected based on experience with Telmisartan

2) expected based on experience with hydrochlorothiazide

3) side effects that were not observed in clinical studies with simultaneous use of telmisartan and hydrochlorothiazide, but are expected during the use of the drug Telpres Plus

Respiratory disorders:

respiratory distress syndrome (including pneumonia and non-cardiogenic pulmonary edema) 3), shortness of breath 3).

Heart disorders:

arrhythmias, tachycardia, bradycardia.

Vascular disorders:

pronounced decrease in blood pressure (including orthostatic hypotension) 3).

Nervous system disorders:

syncope / syncope3), paresthesia3), sleep disorders3), insomnia3), dizziness3), increased excitability2), headache2).

Mental disorders:

anxiety3), depression3).

Disorders of the gastrointestinal tract:

Diarrhea3), dry oral mucosa3), flatulence3), abdominal pain3), constipation3), vomiting3), gastritis3), decreased appetite2), anorexia2), hyperglycemia2), hypercholesterolemia2), pancreatitis2), dyspepsia1) 2), ).

Disorders of the liver and biliary tract:

abnormal liver function3), jaundice (hepatocellular or cholestatic) 2).

Violations of the skin and subcutaneous tissues:

Eczema1), drug rash1), 2), toxic epidermal necrosis1), 2), erythema3), skin itch3), rash3), increased sweating3), photosensitization reaction2).

Disorders of the musculoskeletal and connective tissues:

backache3), muscle spasms3), myalgia3), arthralgia3), gastrocnemius muscle cramps3), arthrosis1), tendinitis-like symptoms1), chest pain3).

Violations of the blood and lymphatic system:

iron deficiency anemia1), aplastic anemia2), hemolytic anemia2), thrombocytopenia1), eosinophilia1), leukopenia2), neutropenia / agranulocytosis2), thrombocytopenia2).

Kidney and urinary tract disorders:

renal failure1), 2), including acute renal failure1), interstitial nephritis2), glycosuria2).

Violations by the organ of vision:

visual impairment3), transient blurred vision3), xantopsia2), acute angle-closure glaucoma2), acute myopia2).

Violations of the genital and breast organs:

Impotence3).

Infectious and parasitic diseases:

sepsis, including fatal cases1), upper respiratory tract infections (bronchitis, pharyngitis, sinusitis) 1), 3), urinary tract infections (including cystitis) 1), inflammation of the salivary glands 2).

Impact on the results of laboratory and instrumental studies:

increased concentration of creatinine in blood plasma3), increased activity of liver enzymes3), increased activity of creatine phosphokinase3), increased activity of concentration of blood uric acid3), hypertriglyceridemia 2), hypokalemia 2), 3), hypomagnesia2), hyperkalemia 1), hyponatremia 2), 3) hyperuricemia3), decreased BCC2), hypoglycemia (in patients with diabetes mellitus) 1), impaired glucose tolerance2), decreased hemoglobin in the blood1).

Immune system disorders:

angioedema (including fatal cases) 3), anaphylactic reactions1), 2), lupus-like reactions2), worsening or worsening symptoms of systemic lupus erythematosus3), necrotic vasculitis2), systemic vasculitis2), recurrent systemic lupus erythematosus2), vasculitis2)

General disorders and disorders at the site of administration:

influenza-like syndrome3), fever2), weakness 1), 2).

- Hypersensitivity to the active substances or auxiliary components of the drug or other sulfonamide derivatives;

- Pregnancy;

- The period of breastfeeding;

- Obstructive diseases of the biliary tract;

- Severe abnormal liver functions (Child-Pugh class C);

- Severe renal dysfunction (CC less than 30 ml / min);

- Refractory hypokalemia, hypercalcemia;

- Simultaneous use with aliskiren in patients with diabetes mellitus and / or impaired renal function (glomerular filtration rate less than 60 ml / min / 1.73 m2);

- Simultaneous use of ACE inhibitors in patients with diabetic nephropathy;

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

- Age up to 18 years (efficacy and safety have not been established).

Carefully:

- Bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney (see section "Special instructions");

- Liver dysfunction (class A and B according to Child-Pugh classification) (see section "Special instructions");

- Reduction of BCC due to previous diuretic therapy, restriction of salt, diarrhea or vomiting;

- Hyperkalemia;

- Condition after kidney transplantation (no experience);

- Chronic heart failure III-IV functional class (FC) according to the classification of the New York Heart Association;

- Hypercalcemia;

- Hypercholesterolemia;

- Hypertriglyceridemia;

- Coronary heart disease;

- Progressive liver disease (risk of developing hepatic coma);

- Aortic and mitral valve stenosis;

- Idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy);

- Diabetes;

- Primary hyper aldosteronism;

- Gout, hyperuricemia;

- Systemic lupus erythematosus;

- Secondary angle-closure glaucoma (due to the presence of hydrochlorothiazide in the composition);

- Use in patients of the Negroid race;

- Experience of use in patients with renal impairment (CC more than 30 ml / min) is limited, but does not confirm the development of side effects from the kidneys and dose adjustment is not required;

- Simultaneous use with ACE inhibitors or aliskiren;

- Simultaneous use with potassium preparations, potassium-sparing diuretics.

Drug interactions

Telmisartan

Telmisartan may increase the antihypertensive effect of other antihypertensive drugs. Other types of interactions of clinical significance have not been identified.

Combined use with digoxin, warfarin, hydrochlorothiazide, glibenclamide, ibuprofen, paracetamol, simvastatin and amlodipine does not lead to clinically significant interaction.

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

Concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes or renal failure (GFR less than 60 ml / min / 1.73 m2 of body surface area) and is not recommended for other patients. Simultaneous use of telmisartan and ACE inhibitors is contraindicated in patients with diabetic nephropathy.

Data from clinical studies have shown that double blockade of the RAAS due to the combined use of ACE inhibitors, ARA II or aliskiren is associated with an increased incidence of adverse events, such as arterial hypotension, hyperkalemia and impaired renal function (including acute renal failure) compared to using only one drug acting on the RAAS.

The risk of developing hyperkalemia may increase when used in conjunction with other drugs that can cause hyperkalemia (potassium-containing dietary supplements and salt substitutes containing potassium and potassium-sparing diuretics (spironolactone, eplerenone, triamterene, or amiloride), nonsteroidal anti-inflammatory drugs (NPVV). 2 (COX)), heparin, immunosuppressants (cyclosporine, tacrolimus, trimethoprim)). If necessary, against the background of documented hypokalemia, the combined use of drugs should be carried out with caution and regularly monitor the content of potassium in the blood plasma.

Digoxin

When co-administration of telmisartan with digoxin, an increase in the mean Cmax of digoxin in the blood plasma by 49% and a minimum concentration by 20% was noted. At the beginning of treatment, when selecting a dose and stopping treatment with telmisartan, the concentration of digoxin in the blood plasma should be carefully controlled to maintain it within the therapeutic range.

Potassium-sparing diuretics or potassium-containing dietary supplements

Angiotensin II receptor antagonists, such as telmisartan, reduce the potassium loss caused by diuretics. Potassium-sparing diuretics, for example, spironolactone, eplerenone, triamterene or amiloride, potassium-containing dietary supplements or salt substitutes can lead to a significant increase in plasma potassium. If concomitant use is indicated, since there is documented hypokalemia, they should be used with caution and against the background of regular monitoring of potassium in the blood plasma.

Lithium preparations

When lithium preparations were taken together with ACE and APA II inhibitors, including telmisartan, there was a reversible increase in the concentration of lithium in the blood plasma and its toxic effect. If you need to use this combination of drugs is recommended to carefully monitor the concentration of lithium in the blood plasma.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs (including acetylsalicylic acid in doses used for anti-inflammatory treatment, COX-2 inhibitors and non-selective NSAIDs) can weaken the antihypertensive effect of APA II. In some patients with impaired renal function (for example, patients with dehydration, elderly patients with impaired renal function), the combined use of APA II and cyclooxygenase-2 depressant drugs can lead to further deterioration of renal function, including the development of acute renal failure, which, as a rule is reversible. Therefore, the joint use of drugs should be carried out with caution, especially in elderly patients. Adequate fluid intake should be ensured, in addition, at the beginning of the joint use and periodically in the future, indicators of renal function should be monitored.

Diuretics (thiazide or loop diuretics)

Prior treatment with high doses of diuretics, such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic), can lead to hypovolemia and risk of developing hypotension at the beginning of treatment with telmisartan.

Other antihypertensive drugs

The effect of telmisartan may be enhanced by the combined use of other antihypertensive drugs. Based on the pharmacological properties of baclofen and amifostine, it can be assumed that they will enhance the therapeutic effect of all antihypertensive drugs, including telmisartan. In addition, orthostatic hypotension may increase with alcohol, barbiturates, narcotic drugs, or antidepressants.

Corticosteroids (for systemic use)

Corticosteroids weaken the effect of telmisartan.

Hydrochlorothiazide

When applied simultaneously with:

- ethanol, barbiturates or narcotic analgesics: the risk of orthostatic hypotension;

- hypoglycemic agents for oral administration and insulin: may require correction of the dose of hypoglycemic agents for oral administration and insulin;

- Metformin: the risk of lactic acidosis;

- colestyramine and colestipol: in the presence of anionic exchange resins, the absorption of hydrochlorothiazide is disturbed;

- cardiac glycosides: the risk of hypokalemia or hypomagnesaemia caused by thiazide diuretics, the development of arrhythmias caused by taking cardiac glycosides;

- pressor amines (for example, norepinephrine): possible weakening of the effect of pressor amines;

- non-depolarizing muscle relaxants (for example, tubocurarine chloride): hydrochlorothiazide may enhance the effect of non-depolarizing muscle relaxants;

- anti-gouty agents: the concentration of uric acid in the blood serum may increase and, therefore, changes in the dose of uricosuric agents may be required. The use of thiazide diuretics increases the frequency of hypersensitivity reactions to allopurinol;

- calcium supplements and vitamin D: thiazide diuretics can increase the calcium content in blood serum due to a decrease in its excretion by the kidneys. If you want to use calcium supplements, you should regularly monitor the calcium content in the blood and, if necessary, change the dose of calcium supplements;

- beta-blockers and diazoxide: thiazide diuretics can increase hyperglycemia caused by beta-blockers and diazoxide;

- m-holinoblokatorami (for example, atropine, biperidine): decrease in motility of the gastrointestinal tract, increase in bioavailability of thiazide diuretics;

- amantadine: clearance of amantadine can be reduced by hydrochlorothiazide, which leads to an increase in the concentration of amantadine in the blood plasma and possible toxicity;

- cytotoxic agents (for example, cyclophosphamide, methotrexate): reduction of renal excretion of cytotoxic agents and enhancement of their myelosuppressive action;

- NSAIDs: combined use with thiazide diuretics can lead to a decrease in diuretic and antihypertensive effect;

- agents that lead to excretion of potassium and hypokalemia (for example, diuretics, potassium deducing; laxatives; glucocorticosteroids, calcitonin, ACTH (adrenocorticotropic hormone), glycyrrhizic acid (contained in licorice root), amphotericin B; carbenoxolone; benzylcycrolysic acid; ): increased hypokalemic effect. The hypokalemia caused by hydrochlorothiazide is compensated by the potassium-sparing effect of telmisartan;

- theophylline: increased risk of hypokalemia;

- amiodarone: simultaneous use with thiazide diuretics may lead to an increased risk of arrhythmias associated with hypokalemia;

- potassium-sparing diuretics, potassium preparations, other means capable of increasing the serum serum levels (for example, heparin) or the replacement of sodium in sodium chloride with potassium salts can lead to hyperkalemia.

It is recommended to periodically monitor the content of potassium in the blood plasma in cases where the drug Telpres Plus is prescribed together with drugs that can cause hypokalemia, as well as with drugs that can increase the content of potassium in the blood serum.

Special instructions

Overdosage

• Brand name: Telpres Plus
• Active ingredient: Hydrochlorothiazide, Telmisartan
• Manufacturer: Pharmproject