► ApoValsart HCT (hydrochlorothiazide + valsartan) - Medycyna Praktyczna

ApoValsart HCT (hydrochlorothiazide + valsartan) - coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
ApoValsart HCT coated tablets; 25 mg + 160 mg (1 tablet contains: 160 mg valsartan, 25 mg hydrochlorothiazide); 28 tabl. Apotex Inc. 25.83 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:hydrochlorothiazide + valsartan

The drug is available on prescription

What is ApoValsart HCT?

A medicine that reduces blood pressure. Combined preparation containing an angiotensin II receptor antagonist (valsartan) and a diuretic (hydrochlorothiazide).

What does ApoValsart HCT contain and how does it work?

It is a combined preparation containing 2 active substances, valsartan and hydrochlorothiazide. Valsartan belongs to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is blocking angiotensin II receptors which prevents their binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which is derived from the English name Angiotensin II Receptor Blockers). Agiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The effect of valsartan, like other sartans, effectively counteracts the effects of angiotensin II and leads to a decrease in blood pressure. Unlike drugs from the angiotensin-converting enzyme inhibitors, sartans do not exacerbate the effects of bradykinin-dependent, for example, cough. Sartans are used as medicines to lower blood pressure and to treat and prevent diseases of the cardiovascular system.
The other active substance is hydrochlorothiazide, a diuretic thiazide diuretic that increases the volume of urine output. It inhibits the return of sodium ions in the kidney tubules, resulting in increased sodium excretion in the urine and increasing the volume of excreted water. Increased sodium excretion is accompanied by increased excretion of potassium, Magnesium and chlorine, while Calcium excretion decreases. The loss of potassium in the urine is less pronounced in the presence of valsartan. The action of thiazides also leads to vasodilatation and reduction of vascular resistance.
The antihypertensive effect of the preparation is stronger than when each component is used alone. The antihypertensive effect is clearly noticeable within 2 weeks of the start of treatment and the full antihypertensive effect is obtained after 4-8. weeks of use.

When should I use ApoValsart HCT?

It is indicated for the treatment of essential hypertension in adults who do not achieve sufficient reduction in blood pressure with either valsartan or hydrochlorothiazide monotherapy.

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used.You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients or sulfonamides. You can not use the preparation if you are present:
· Severe liver problems, liver biliary cirrhosis or cholestasis (cholestasis)
· Severe renal dysfunction (creatinine clearance less than 30 ml / min)
· anuria
· Hypokalemia-resistant (decrease in potassium in the blood), hyponatraemia (decrease in blood sodium), hypercalcemia (increased calcium in the blood)
· Symptomatic hyperuricemia (symptoms resulting from increased uric acid levels in the blood).
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.

Take special care with ApoValsart HCT?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Because valsartan in the preparation may cause hyperkalaemia (increased potassium in the blood), it is not recommended to use medicines that may increase the level of potassium in the blood, such as potassium supplements, potassium salts, potassium sparing diuretics or Heparin .
Due to the content of thiazide diuretic, the preparation may cause hypokalaemia (decrease in potassium in the blood). Disorders of potassium in the blood (both hypokalemia and hyperkalemia) can cause serious arrhythmias. Your doctor will recommend regular and frequent monitoring of potassium levels in your blood.
The hydrochlorothiazide contained in the preparation may affect the water-electrolyte balance and cause deficiencies of sodium, potassium, magnesium and chlorine. During the period of application, the doctor will recommend regular monitoring of the concentration of these ions. The product reduces the excretion of calcium in the urine and may cause a slight increase in blood calcium (hypercalcemia). Significant hypercalcemia may be the result of unrecognized hyperparathyroidism. In the case of significant hypercalcemia, tests to assess parathyroid function should be performed. Before performing parathyroid function tests, the preparation should be discontinued (only after consultation with a doctor and on his recommendation).
If you experience symptoms such as: dry mouth, increased thirst, weakness, lethargy, drowsiness, restlessness, convulsions, confusion, muscle aches and cramps, muscle fatigue, hypotension, oliguria, increased heart rate (tachycardia), nausea or vomiting, you should consult your doctor, because these symptoms may indicate a disturbance of fluid and electrolyte balance.
Caution should be exercised because the preparation rarely, especially at the beginning of treatment, may cause symptomatic hypotension, especially in people with circulating, dehydrated or sodium deficient blood volume (eg, people taking previously high doses of diuretics, using a low salt diet) after diarrhea or vomiting). Sodium deficiency and adequate hydration must be corr ected before starting treatment.
In patients at higher risk of renal dysfunction, whose renal function depends on the activity of the renin-angiotensin-aldosterone system (eg in patients with severe congestive heart failure , bilateral renal artery stenosis or renal artery stenosis of the sole active kidney) drug use those acting on the renin-angiotensin-aldosterone system (such as, for example, valsartan) may be associated with a risk of acute renal failure , oliguria, and increased levels of urea and creatinine in the blood. The preparation should not be used in this group of patients.
It is not recommended to use the preparation in patients with primary hyperaldosteronism, because the effect of the preparation in this group of patients is not effective.
Caution should be exercised in the case of impaired left-ventricular blood flow (occurrence of aortic or mitral stenosis, hypertrophic cardiomyopathy).
No dose adjustment is required in people with renal impairment, provided the creatinine clearance is greater than 30 ml / min. Your doctor will recommend periodic monitoring of potassium, creatinine and uric acid levels in your blood.If the creatinine clearance is less than 30 ml / min, the use of the preparation is contraindicated.
There is no data on the use of the preparation in patients after recent kidney transplantation.
People should be treated with caution in patients with mild or moderate hepatic impairment without bile stasis. The preparation is contraindicated in case of severe liver dysfunction, biliary cirrhosis or cholestasis (cholestasis).
Hydrochlorothiazide contained in the preparation may cause systemic lupus erythematosus or exacerbate its symptoms.
Hydrochlorothiazide reduces Glucose tolerance. During the period of application, patients with diabetes should be careful and monitor glucose levels. The preparation may reduce the effectiveness of oral antidiabetic agents and insulin and may need to be adjusted by the doctor.
Hydrochlorothiazide may increase the levels of lipids (cholesterol and triglycerides) and uric acid in the blood.
During the use of diuretics may occur a hypersensitivity reaction of the skin to light (rash, fever, vasculitis). If it occurs, please consult your doctor, as it may be necessary to stop using the product. If it is necessary to resume therapy in the future, skin protection should be protected against solar and UV radiation.
Caution should be exercised in patients who have previously experienced hypersensitivity reactions to other angiotensin receptor blockers. Hydrochlorothiazide may cause hypersensitivity reactions, especially in people with a history of allergies or bronchiectasis.

Does this preparation affect the ability to drive vehicles?
The effects of the preparation on the ability to drive vehicles and operate machinery and equipment have not been studied. It should be remembered that the preparation may cause dizziness, drowsiness, tiredness or other symptoms that may impair psychophysical fitness and ability to drive vehicles and operate machines and equipment.

Dosage of ApoValsart HCT

The preparation is in the form of coated tablets. It is intended for oral use. The tablets can be taken with or without water. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
1 tablet once a day. The doctor will individually adjust the dosage and adjust the doses of the individual components of the preparation. If necessary, the doctor may increase the daily dose of each ingredient gradually, up to a maximum dose of 320 mg + 25 mg. When adjusting the dose, it should be taken into account that the antihypertensive effect is noticeable within 2 weeks and the full antihypertensive effect is achieved within 4 weeks (in some people within 8 weeks).
No dose adjustment is required in patients with mild or moderate renal impairment (creatinine clearance greater than 30 ml / min). In patients with severe renal impairment (creatinine clearance less than 30 ml / min), the use of the preparation is contraindicated.
In people with mild or moderate hepatic impairment without bile stasis, caution should be used and no doses higher than 80 mg valsartan should be used daily. The preparation is contraindicated in case of severe liver dysfunction, biliary cirrhosis or cholestasis (cholestasis).
Elderly patients do not need to adjust their dosage.
Do not use the preparation in children and adolescents up to 18 years of age, due to the lack of data on the safety and efficacy of the preparation in this age group.

Can I use ApoValsart HCT during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
Medicines from the group of sartans and hydrochlorothiazide may have a detrimental effect on pregnancy, fetus and newborn development.The use of the preparation in the second and third trimester of pregnancy is contraindicated; in the first trimester of pregnancy, the use of the preparation is not recommended.
The preparation should not be initiated during pregnancy. If a woman who is using the product plans to become pregnant should consult a doctor who will recommend changing the antihypertensive treatment. If you suspect or confirm pregnancy during the period of taking the preparation, you should consult a doctor as soon as possible because immediate discontinuation of the preparation is required. If necessary, your doctor will prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.
The preparation may increase concentration and exacerbate the toxic effects of lithium salts. The simultaneous use of lithium is not recommended, and if necessary, combination therapy should be used with caution and blood levels of lithium should be closely monitored.
The parallel use of valsartan with preparations increasing the concentration of potassium is not recommended. Parallel use of these drugs (potassium salts, some diuretics and antihypertensive agents, e.g. spironolactone, triamterene, amiloride, eplerenone, potassium supplements, trimethoprim, tacrolimus, cyclosporin, heparin) and potassium-containing salt substitutes may lead to increased potassium levels in the blood (hyperkalaemia ). If it is necessary to use them, the doctor will recommend regular monitoring of potassium in the blood.
Caution is required in the following cases.
The preparation may increase the effect of other antihypertensive agents used in parallel (eg ACE inhibitors, beta blockers, calcium antagonists) or other medicines that may lower blood pressure (eg some antidepressants, hypnotics, sedatives, barbiturates, opioids). There may be an increase in antihypertensive effect and postural hypotension (also if alcohol is consumed in parallel).
The preparation may reduce the effect of catecholamines (eg adrenaline, norepinephrine) on the muscularis arteries.
Non-steroidal anti-inflammatory drugs (e.g. Acetylsalicylic acid , Ibuprofen , Ketoprofen , indometacin, selective COX-2 inhibitors) may reduce the antihypertensive effect of the preparation and may cause renal dysfunction and increase in potassium in the blood. Adequate hydration and regular renal function should be ensured. Caution should be exercised, especially in elderly patients.
Parallel use of the preparation with drugs that cause potassium loss (eg corticosteroid s, tetracosactis, amphotericin, carbenoxolone, ACTH, penicillin G, salicylic acid and its derivatives, laxatives, some diuretics) may increase the risk of hypokalaemia (decreases in potassium in the blood) and increase I. The amount of potassium in the blood should be monitored.
If the preparation is used in parallel with the following drugs that can cause serious type-heart rhythm disturbancestorsade de pointes caution should be exercised because of the risk of hypokalemia (regular monitoring of potassium in the blood and ECG is recommended). Hypokalemia increases the risk of arrhythmiastorsade de pointes:
· Class Ia and III antiarrhythmics (such as quinidine, hydroquinidine, disopyramide, Amiodarone , sotalol, dofetilide, ibutilide)
· Some antipsychotics: phenothiazine derivatives (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazole), benzamides (amisulpiride, sulpiride, sultopride, thiapride), butyrophenone derivatives (stoperydol, Haloperidol )
· Other medicines: bepridil, cisapride, difemanil, Erythromycin (intravenously), halofantrine, mizolastine, pentamidine, terfenadine, spparfloxacin, moxifloxacin, vincamine (intravenously).
The preparation may cause hypokalaemia or hypomagnesaemia, which intensifies the toxicity of cardiac glycosides. In patients using cardiac glycosides, caution should be exercised and potassium levels should be monitored and ECG examinations performed.
Thiazide diuretics may increase serum calcium. Parallel use of calcium or vitamin D supplements may additionally increase hypercalcemia; the concentration of calcium in the blood serum should be monitored and the calcium dosage should be adjusted.
The preparation may reduce the effectiveness of oral antidiabetic agents and insulin and may need to be adjusted by the doctor. You should monitor your blood glucose.
Parallel use with Metformin causes a risk of lactic acidosis associated with possible renal failure.
The use of hydrochlorothiazide with beta-blockers or diazoxide may increase the risk of hyperglycaemia.
As the preparation may increase the concentration of uric acid in the blood, it may be necessary to adjust the doses of medicines used to treat gout (probenecid, sulfinpyrazone, Allopurinol ). It is also possible to intensify hypersensitivity reactions to allopurinol.
Ciclosporin may increase the risk of gout-type complications as a result of the increase in the concentration of uric acid in the blood.
Anticholinergics (eg atropine, biperiden) may increase the effect of diuretics by lowering intestinal peristalsis.
The preparation may increase the risk of side effects of amantadine.
Bile acid medications (cholestyramine, colestipol) may reduce the absorption of the preparation from the gastrointestinal tract.
The preparation may increase the toxic effect on the bone marrow of cytotoxic medicines such as cyclophosphamide and Methotrexate .
The preparation may increase the effect of skeletal muscle relaxants (eg tubocurarines).
Very rarely, the preparation used with methyldopa may contribute to the development of haemolytic anemia.
The concomitant use of carbamazepine may result in hyponatremia (reduction of sodium in the blood). The amount of sodium in the blood should be monitored.
Contrasting agents containing Iodine in dehydrated patients increase the risk of acute renal failure. Ensure adequate hydration before using these preparations.

What side effects can occur?

Like all medicines, ApoValsart HCT can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Adverse reactions associated with the use of the preparation include: dizziness, fainting, paresthesia (sensory disturbances, stinging and tingling sensations), blurred vision, tinnitus, fatigue, hypotension, cough, pulmonary edema, diarrhea, muscle and joint pain, renal function, dehydration, increased blood uric acid, urea, creatinine, bilirubin, as well as hypokalemia, hyponatremia and neutropenia (decrease in neutrophil count).
It is also possible to rule out side effects previously reported for each component of the preparation used independently. Side effects associated with the use of valsartan include: anemia, thrombocytopenia, hematocrit reduction, hypersensitivity reactions (including serum sickness, angioedema, rash, pruritus), vasculitis, increased liver enzymes, increased bilirubin in the blood, increased potassium levels blood (hyperkalemia), abdominal pain. Side effects associated with hydrochlorothiazide include: loss of appetite, nausea, vomiting, constipation, discomfort in the gastrointestinal tract, pancreatitis (very rarely), intrahepatic cholestasis or jaundice, haematological abnormalities (haemolytic anemia, decreased white blood cell count [leukopenia], decrease in platelet count (thrombocytopenia), sometimes with purpura, bone marrow depression), depression, sleep disturbances, headaches, arrhythmia, orthostatic hypotension, sexual dysfunction, respiratory failure with inflammation and pulmonary edema (very rare), reactions hypersensitivity (urticaria, rash), hypersensitivity to light, and very rare toxic necrosis, necrotizing vasculitis, lupus-like skin reactions, activation of cutaneous form of Lupus Erythematosus.

Other preparations on the Polish market containing hydrochlorothiazide + valsartan

Awalten (coated tablets)
Axudan HCT (coated tablets)
Co-Bespres (coated tablets)
Co-Diovan (coated tablets)
Co-Nortivan (coated tablets)
Co-Valsacor (coated tablets)
Tensart HCT (coated tablets)
Valsartan + HCT Genoptim (coated tablets)
Valsartan + hydrochlorothiazide Aurobindo (coated tablets)
Valsartan + hydrochlorothiazide Krka (coated tablets)
Valsartan HCT Mylan (coated tablets)
Valsotens HCT (coated tablets)
Valtap HCT (coated tablets)
Vanatex HCT (coated tablets)