POLPHARMA #Circulatory_system #Decrease_in_pressure #HEALTH_CARE
Indications
Hypertension in patients whose blood pressure is not adequately controlled by valsartan or hydrochlorothiazide monotherapy.
Application
The recommended dose of Vanatex combi 80/12.5 mg is 1 tablet 1 time per day. with an insufficient decrease in blood pressure after 3-4 weeks of treatment, it is recommended to consider the possibility of continuing treatment at a dosage of 1 tablet 160/12.5 mg 1 time per day. 160/25 mg tablets are prescribed to patients who do not achieve a sufficient reduction in blood pressure when using 160/12.5 mg tablets. if in the future, with the use of 160/25 mg tablets, blood pressure does not decrease enough, it is recommended to consider continuing treatment at a dosage of 320/12.5 mg (valsartan and hydrochlorothiazide in another dosage form should be used to obtain such a dosage). a dose of 320/25 mg is prescribed for patients who do not achieve a sufficient reduction in blood pressure when using a dose of 320/12.5 mg.
The maximum daily dose is 320/25 mg (2 tablets 160/12.5 mg).
The maximum antihypertensive effect is achieved within 2-4 weeks.
Vanatex Combi can be taken with or without food.
Additional information for special patient groups
Renal failure. Dose adjustment is not required in patients with mild to moderate renal insufficiency (creatinine clearance ≥30 ml/min). Due to the presence of hydrochlorothiazide, Vanatex Combi is contraindicated in patients with severe renal insufficiency.
Liver failure. For patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Vanatex Combi is contraindicated in patients with severe hepatic impairment.
Elderly patients. Dose adjustment is not required in elderly patients.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-based preparations or any of the excipients. severe liver failure, cirrhosis and cholestasis. severe renal failure (creatinine clearance 30 ml / min), anuria. persistent hypokalemia, hyponatremia, hypercalcemia and symptomatic hyperuricemia.
Side effects
Adverse reactions when using valsartan / hydrochlorothiazide
From the side of metabolism and nutrition: infrequently - dehydration.
From the nervous system: very rarely - dizziness; infrequently - paresthesia, hypesthesia; unknown - fainting, insomnia.
On the part of the organ of vision: infrequently - blurred vision, impaired vision.
On the part of the organ of hearing: infrequently - ringing in the ears, otitis media.
Since the cardiovascular system: infrequently - arterial hypotension, tachycardia.
From the respiratory system: infrequently - cough; unknown - non-cardiogenic pulmonary edema.
From the digestive tract: very rarely - diarrhea.
From the musculoskeletal system: infrequently - myalgia (muscle pain); very rarely - arthralgia.
From the urinary system: unknown - impaired renal function.
General disorders: infrequently - fatigue.
Laboratory indicators: unknown - increased levels of uric acid in blood plasma, increased levels of bilirubin and creatinine in blood plasma, hypokalemia, hyponatremia, increased levels of urea nitrogen in the blood, neutropenia.
Additional information on the individual components of the preparation. Undesirable reactions, which were previously reported, caused by one of the individual components of the preparation, may also be a potential undesirable effect of Vanatex Combi.
Adverse reactions when using valsartan
From the blood and lymphatic system: unknown - decrease in hemoglobin, decrease in hematocrit, neutropenia, thrombocytopenia.
From the immune system: unknown - other allergic / hypersensitivity reactions, including serum sickness.
From the side of metabolism and nutrition: unknown - an increase in the level of potassium in the blood plasma, hyponatremia.
On the part of the organ of hearing: infrequently - dizziness (vertigo).
From the side of the cardiovascular system: unknown - vasculitis.
From the gastrointestinal tract: infrequently - abdominal pain.
On the part of the digestive system: unknown - an increase in liver function, including an increase in the level of bilirubin in the blood plasma.
From the skin and subcutaneous tissues: unknown - Quincke's edema (angioneurotic edema), rash, itching.
From the urinary system: unknown - renal failure and impaired renal function, increased plasma creatinine levels.
From the respiratory system: very rarely - bronchitis, infections of the upper respiratory tract.
Adverse reactions when using hydrochlorothiazide. Hydrochlorothiazide has been widely used for many years, often at higher doses than those contained in Vanatex Combi. The following adverse reactions have been reported in patients treated with thiazide diuretic monotherapy, including hydrochlorothiazide.
From the blood and lymphatic system: rarely - thrombocytopenia, sometimes with purpura; very rarely - agranulocytosis, leukopenia, hemolytic anemia, depression of bone marrow function.
From the immune system: very rarely - allergic reactions (hypersensitivity reactions).
On the part of the psyche: rarely - depression, sleep disturbance.
From the nervous system: rarely - headache.
From the side of the cardiovascular system: rarely - arrhythmia; often - orthostatic hypotension.
From the respiratory system: very rarely - shortness of breath (shortness of breath), including pneumonia and pulmonary edema.
From the gastrointestinal tract: often - lack of appetite, mild nausea and vomiting; rarely - constipation, discomfort in the gastrointestinal tract; very rarely - pancreatitis.
From the digestive system: rarely - cholestasis, jaundice.
From the skin and subcutaneous tissues: often - urticaria and other types of rash; rarely - photosensitivity; very rarely - necrotizing vasculitis and toxic epidermal necrolysis, systemic lupus erythematosus, erythematous-like reactions, reactivation of skin manifestations of lupus erythematosus.
From the reproductive system and mammary glands: often - impotence.
special instructions
Changes in the level of electrolytes in blood plasma. valsartan. simultaneous use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that can increase potassium levels (heparin, etc.) is not recommended. if necessary, control of the potassium content should be carried out.
Hydrochlorothiazide. Hypokalemia has been reported with thiazide diuretics, including hydrochlorothiazide. Frequent monitoring of potassium levels in blood plasma is recommended.
Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatremia and hypochloremic alkalosis. Thiazides, including hydrochlorothiazide, increase the excretion of magnesium in the urine, which can lead to hypomagnesemia. Calcium excretion decreases due to the intake of thiazide diuretics. This can lead to hypercalcemia.
As with any patient receiving diuretic treatment, it is necessary to periodically determine the level of electrolytes in the blood plasma at appropriate intervals.
Patients with hypovolemia. The condition of patients taking thiazide diuretics, including hydrochlorothiazide, should be monitored for clinical manifestations of water and electrolyte imbalance. In severe hypovolemia in patients taking high-dose diuretics, symptomatic hypotension may rarely occur after initiation of Vanatex Combi therapy. Hypovolemia must be corrected before starting treatment with Vanatex Combi.
Patients with severe chronic heart failure. The use of Vanatex Combi in patients with severe chronic heart failure has not been studied.
Stenosis of the renal artery. Vanatex Combi should not be used to treat hypertension in patients with unilateral or bilateral renal artery stenosis or renal artery stenosis of a solitary kidney, as these patients may have elevated plasma urea and creatinine levels.
Primary hyperaldosteronism. Patients with primary hyperaldosteronism should not be treated with Vanatex Combi because their renin-angiotensin system is not activated.
Stenosis of the aortic and mitral valve, obstructive hypertrophic cardiomyopathy. As with other vasodilators, special care must be taken when treating patients with aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy.
Impaired kidney function. Due to the inhibition (inhibition) of the renin-angiotensin-aldosterone system, the use of Vanatex Combi may also be associated with impaired renal function. Vanatex Combi should not be used in such patients.
Dose adjustment is not required in patients with impaired renal function and creatinine clearance ≥30 ml / min. Periodic monitoring of plasma potassium, creatinine and urea levels is recommended if Vanatex Combi is used in patients with impaired renal function. With a creatinine clearance of 30 ml / min, Vanatex Combi should not be used.
Kidney transplant. There is currently no experience with the safe use of Vanatex Combi in patients who have recently undergone kidney transplantation.
Liver failure. Patients with mild to moderate hepatic impairment without cholestasis should take Vanatex Combi with caution.
Systemic lupus erythematosus. Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or intensify systemic lupus erythematosus.
Other metabolic disorders (metabolic disorders). Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and increase plasma levels of cholesterol, triglycerides, and uric acid. In patients with diabetes, it may be necessary to adjust (correct) the dose of insulin or oral preparations to lower blood glucose levels.
Thiazides can reduce urinary calcium excretion and lead to a temporary and slight increase in plasma calcium levels in the absence of known disorders of calcium metabolism. Severe hypercalcemia may indicate suspected hyperparathyroidism (hyperfunction of the parathyroid glands). It is necessary to stop taking thiazides before conducting a study of the function of the parathyroid glands.
Light sensitivity. Cases of photosensitivity reactions have been reported during treatment with thiazide diuretics. If a photosensitivity reaction occurs during treatment, it is recommended to stop taking the preparation. If repeated administration of diuretics is considered necessary, it is recommended to protect vulnerable areas from the sun or artificial ultraviolet A.
Doping control. It should be borne in mind that the preparation can lead to a positive reaction in anti-doping controls.
General information. Caution should be exercised in patients who have a history of hypersensitivity to other AT II receptor antagonists. Allergic reactions to hydrochlorothiazide are more likely in patients with allergies and asthma.
Excipients. Patients with rare hereditary conditions of galactose intolerance, lactase deficiency or glucose malabsorption syndrome should not take this preparation.
Use during pregnancy and lactation
Pregnancy. Valsartan. The use of AT II receptor antagonists (AIIRAs) is not recommended in the first trimester of pregnancy. It is known that the effect of AT II receptor antagonists (AIIRAs) on the uterus, if prescribed to pregnant women in the II and III trimester, leads to disruption and death of the developing fetus. The use of AT II receptor antagonists is contraindicated in the II and III trimester of pregnancy.
Hydrochlorothiazide. The experience of using hydrochlorothiazide during pregnancy, especially in the first trimester, is limited. The introduction of a thiazide diuretic into the uterine cavity led to the development of thrombocytopenia in the fetus or newborn, as well as to the development of other adverse events. Hydrochlorothiazide crosses the placenta. Given the pharmacological mechanism of action of hydrochlorothiazide, its use in the II and III trimester can lead to a threat of impaired fetoplacental perfusion and can cause such disorders in the fetus and newborn as jaundice, electrolyte imbalance and thrombocytopenia.
Lactation. There are no data on the use of valsartan during lactation. Hydrochlorothiazide passes into breast milk. Thus, Vanatex Combi is not recommended for use during breastfeeding. If pregnancy is detected during treatment, the preparation should be discontinued as soon as possible.
Children. The safety and efficacy of Vanatex Combi in children have not been established.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. As with other antihypertensive agents, caution is advised when driving or operating machinery.
Interactions
Interactions associated with both valsartan and hydrochlorothiazide
Combined use is not recommended
Lithium. Reversible increases in plasma lithium levels and toxicity have been reported with concomitant use of ACE inhibitors and thiazide, including hydrochlorothiazide. Due to the lack of experience with the combined use of valsartan and lithium, this combination is not recommended. If it is necessary to use such a combination, careful monitoring of the level of lithium in the blood plasma is recommended.
Combined use requiring caution
Other antihypertensive preparations. Vanatex Combi may enhance the effect of other preparations with antihypertensive properties (for example, ACE inhibitors, β-adrenergic blockers, calcium channel blockers).
Pressor amines (eg norepinephrine, epinephrine). Perhaps a decrease in the severity of the reaction to pressor amines, insufficient to exclude the use.
NSAIDs, including selective COX-2 inhibitors, acetylsalicylic acid (3 g / day) and non-selective NSAIDs. NSAIDs can weaken the antihypertensive effect of AT II receptor antagonists and hydrochlorothiazide when used simultaneously. In addition, the simultaneous use of the preparation Vanatex Combi and NSAIDs can lead to a deterioration in kidney function and an increase in the level of potassium in the blood plasma. Thus, monitoring of renal function at the beginning of treatment, as well as appropriate hydration, is recommended.
Interactions associated with valsartan
Simultaneous use is not recommended
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase plasma potassium levels. If a medicinal product that affects potassium levels is considered to be combined with valsartan, monitoring of plasma potassium levels is recommended.
There is no interaction. Preparation interaction studies with valsartan did not reveal clinically significant interactions with valsartan or any of the following medicinal products: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide. Digoxin and indomethacin may interact with the hydrochlorothiazide component of Vanatex Combi (see Hydrochlorothiazide Interactions).
Interactions associated with hydrochlorothiazide
Simultaneous use requiring caution
Preparations, the use of which is associated with loss of potassium, and with hypokalemia (for example, with the simultaneous appointment of kaliuretic diuretics, corticosteroids, laxatives, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid and its derivatives). If these preparations must be prescribed in combination with hydrochlorothiazide and valsartan, it is recommended to control the level of potassium in the blood plasma. These medicinal products may increase the effect of hydrochlorothiazide on plasma potassium levels.
Preparations that can cause torsades de pointes ventricular tachycardia:
class Ia antiarrhythmics (eg quinidine, hydroquinidine, disopyramide);
class III antiarrhythmic preparations (eg amiodarone, sotalol, dofetilide, ibutilide);
certain neuroleptics (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol);
others (eg bepridil, cisapride, difemanil, erythromycin (iv), halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine (iv).
Due to the risk of hypokalemia, hydrochlorothiazide should be used with caution in combination with preparations that can cause torsades de pointes ventricular tachycardia.
cardiac glycosides. Hypokalemia or hypomagnesemia caused by thiazide may occur as a side effect that contributes to the development of digitalis arrhythmia.
Calcium salts and vitamin D. The use of thiazide diuretics, including hydrochlorothiazide, with vitamin D or calcium salts may increase plasma calcium levels.
Antidiabetic agents (oral preparations and insulin). Treatment with thiazide diuretics may affect glucose tolerance. Dose adjustment of antidiabetic preparations may be required. Metformin should be used with caution due to the risk of lactic acidosis caused by possible functional renal failure associated with hydrochlorothiazide.
Blockers of β-adrenergic receptors and diazoxide. Simultaneous use of thiazide diuretics, including hydrochlorothiazide, with β-adrenergic blockers may increase the risk of hyperglycemia. Thiazide diuretics, including hydrochlorothiazide, may increase the hyperglycemic effect of diazoxide.
Preparations used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol). Dose adjustment of uricosuric preparations may be required as hydrochlorothiazide may increase plasma uric acid levels. An increase in the dose of probenecid or sulfinpyrazone may be required. The simultaneous administration of thiazide diuretics, including hydrochlorothiazide, may increase the frequency of allergic reactions to allopurinol.
Anticholinergics (eg atropine, biperiden). The bioavailability of thiazide diuretics may be increased by anticholinergics, probably due to decreased GI motility and gastric emptying rate.
Amantadine. Thiazides, including hydrochlorothiazide, may increase the risk of adverse effects of amantadine.
Colestyramine and colestipol resins. The absorption of thiazide diuretics, including hydrochlorothiazide, is impaired in the presence of anion exchange resins.
Cytotoxic agents (eg cyclophosphamide, methotrexate). Thiazides, including hydrochlorothiazide, may reduce the excretion of cytotoxic substances by the kidneys and increase their myelosuppressive effect.
Non-depolarizing muscle relaxants (eg tubocurarine). Thiazides, including hydrochlorothiazide, enhance the action of curare derivatives.
Cyclosporine. Concomitant use with cyclosporine may increase the risk of hyperuricemia and gout-like symptoms.
Alcohol, anesthetics and sedatives. May exacerbate orthostatic hypotension.
Methyldopa. There are isolated reports of cases of hemolytic anemia in patients receiving concomitant treatment with methyldopa and hydrochlorothiazide.
Carbamazepine. Patients who receive hydrochlorothiazide concomitantly with carbamazepine may develop hyponatremia. Therefore, such patients should be informed about the possibility of hyponatraemic reactions and be monitored.
Iodine-containing contrast agents. In the case of dehydration caused by a diuretic, there is an increased risk of developing acute renal failure, especially with high doses of iodine. Sufficient hydration is required before taking.
Overdose
Symptoms. an overdose of valsartan can lead to severe arterial hypotension, which, in turn, can cause depression of consciousness, circulatory collapse (vascular insufficiency) and / or shock (coma). in addition, such signs and symptoms may occur with an overdose of hydrochlorothiazide: nausea, drowsiness, hypovolemia and electrolyte disturbances associated with cardiac arrhythmias and muscle spasms.
Treatment. Therapeutic measures depend on the timing of the meal and the type and severity of the symptoms; circulatory stabilization is very important.
Therapeutic measures depend on the time elapsed from the moment of overdose, as well as the type and severity of symptoms, while the primary measure is the normalization of hemocirculation.
If the preparation has been taken recently, induce vomiting. If a long time has passed after the use of the preparation, it is necessary to use activated charcoal in sufficient quantities.
In case of arterial hypotension, the patient should be given a horizontal position and immediately ensure the restoration of the water-salt balance by introducing an isotonic saline solution.
Valsartan cannot be removed from the body by hemodialysis due to its binding to plasma proteins, but hemodialysis is effective for removing hydrochlorothiazide from the body.
Storage conditions
In a dry, dark place at a temperature not exceeding 30 °C. Keep out of the reach of children.
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