Name:
Normatens.
Description:
The dragee is white or almost white, without scratches, spots or cracks. The shape of the dragee is round, biconvex. The main active ingredient is Reserpine + dihydroergocristine + clopamide. Release form Dragee. Pharmacological group Antihypertensive drugs in combination with diuretics. Rauwolfia alkaloids in combination with diuretics. ATX code C02LA51. Pharmacological properties Normatens is a combined antihypertensive drug containing in its composition 3 complementary components that reduce blood pressure: reserpine, clopamide and dihydroergocristine. This combination allows the use of smaller doses of individual active substances, reduces the risk associated with side effects, and also simplifies dosing of drugs. Reserpine is a rauwolfia alkaloid, a sympatholytic with antipsychotic and antihypertensive effects. Reserpine belongs to the class of adrenergic neuronal blockers. Causes depletion of the neurotransmitter released from the adrenergic vesicles of the presynaptic structure. Reserpine also prevents the uptake and storage of catecholamines and serotonin in the central and peripheral nervous systems. As a result, it will reduce the content of catecholamines in the nervous system and peripheral tissues. Reserpine causes reflex vagotonia. The consequences of the action of reserpine are vasodilation, slowing of the heart rate and a long-term decrease in blood pressure. Clopamid is a medium-strength diuretic, similar to the action of thiazides. It reduces the reabsorption of sodium ions in the cortical segment of the ascending loop of Henle, as well as in the convoluted distal tubules, which causes increased diuresis and natriuresis, as well as a decrease in blood pressure. Inhibition of sodium reabsorption enhances kaliuresis and may lead to hypokalemia. Dihydroergocristine belongs to the group of hydrogenated ergot alkaloids. It is a dopaminergic and serotonergic receptor agonist and an alpha-adrenergic receptor antagonist. Due to its action on the central nervous system, it reduces the tone of the muscles of the blood vessels, reduces the total peripheral vascular resistance, reducing blood pressure. In addition, dihydroergocristine suppresses baroreceptor reflexes and reduces reflex tachycardia. Indications for usePrimary and secondary arterial hypertension, if a sufficient antihypertensive effect is not obtained with monotherapy. The drug can be used in combination with other antihypertensive drugs such as beta-blockers and vasodilators. Method of administration and doses Dosage is determined by the doctor, individually for each patient. It is recommended to start treatment with 1 tablet taken once a day. Dragee should be taken during or immediately after a meal. If necessary (only after the doctor’s recommendation), you can increase the dose of the drug up to 3 times a day (every 8 hours) 1 tablet (do not exceed the daily dose of 3 tablets). It must be remembered that, given the mechanism of action and the pharmacological properties of the individual components of the drug, possible antihypertensive inefficiency can be discussed no earlier than after about 14 days from the start of use and, therefore, in this period, the initial dose should not be increased without urgent need. The dose should be increased gradually. Most often, the most effective maintenance dose is 1 tablet once a day. For some patients, an effective maintenance dose is 1 tablet administered every other day. However, sometimes it may be necessary to use 2 tablets in several doses, and in exceptional cases – 3 tablets in several doses (higher doses should not be taken). Dragee should be taken during or immediately after a meal. Children: Not applicable. Dosage for Elderly Patients: No dose adjustment is necessary, but due to the increased risk of hypotension and electrolyte disturbances, special care is advised when using the product. Dosage for patients with renal and hepatic insufficiency: The use of this drug in patients with severe hepatic and renal insufficiency (creatinine clearance < 30 ml / min) is not recommended. Use during pregnancy and lactation Taking into account the potential risk to the fetus, the use of the drug during pregnancy is contraindicated. Do not take the drug during breastfeeding. Influence on the ability to drive vehicles and maintain moving mechanisms Normatens affects the ability to drive vehicles and maintain moving mechanisms. Especially at the beginning of treatment and after increasing the dose of the drug, a feeling of severe weakness and orthostatic hypotension may occur, which impair the ability to drive vehicles and maintain moving mechanisms. Precautions Dosage is established by the doctor, individually for each patient. Periodic monitoring of blood pressure and heart rate is shown to determine the optimal dose of the drug by the doctor. During treatment, certain undesirable effects may occur, which should be paid attention to: a drug with a relatively slow action that lowers blood pressure; do not significantly increase the dose in the initial period of use, due to the possibility of an excessive pressure drop; special care should be taken when used with other drugs that can reduce blood pressure (see: Drug Interactions); during the use of Normatens, the level of glucose and uric acid in the blood serum may increase (periodic monitoring of these parameters is indicated, especially in patients with impaired glucose tolerance and hyperuricemia); care should be taken, and if necessary, reduce the dose of the drug in patients with renal and (or) hepatic insufficiency; do not use in case of severe renal insufficiency (creatinine clearance < 30 ml / min); during treatment, electrolyte disturbances may occur in the form of a decrease in the level of potassium and magnesium in the blood serum (periodic monitoring of the ionogram and possible correction of violations are shown); the elderly may be particularly sensitive to the antihypertensive effect of the drug; in this group of patients, the drug should be used with caution, taking into account the observed impairment of renal function associated with age; during the use of the drug should not drink alcohol; the dose of the described drug should be changed accordingly in case of simultaneous use of drugs that interact with it; in case of a pronounced increase in side effects, the described drug should be replaced with another antihypertensive drug; the drug should not be used in children. It should be remembered that the clinical effect of the use of Normatens occurs after a few days, and sometimes - 4 weeks after the start of treatment. Therefore, the dosage should not be increased if there has not been a decrease in blood pressure at the beginning of treatment. the drug should be taken with caution in elderly patients, as well as in patients with gout, since the drug can increase the level of uric acid in the blood. In connection with an increase in the concentration of glucose in the blood, patients with diabetes mellitus or with metabolic disorders should periodically monitor glycemia or select an adequate dose of a hypoglycemic agent. Due to the presence of sucrose and lactose in the preparation, patients with congenital disorders associated with fructose intolerance: glucose-galactose malabsorption syndrome or sucrose-isomaltose deficiency, Lapp lactase deficiency should not take this drug. Be careful in patients with bronchial asthma and bronchospasm, in case of increased shortness of breath, you should consult a doctor. During treatment, you should not drink alcohol. During treatment, it is recommended to eat foods high in potassium (carrots, spinach, dried fruits, fresh vegetables, cheese, fish) and periodically monitor the level of potassium in the blood due to the possibility of its decrease. In case of bradycardia, the dose of the drug should be reduced or the drug should be discontinued. Before a planned surgical intervention, the use of the drug should be discontinued at least 2 weeks in advance and replaced with another one. You should stop using the drug at least 7 days before the start of electroconvulsive therapy. Contraindications Hypersensitivity to sulfonamides, reserpine and ergot alkaloids, or any other component of the drug; depression, epilepsy, Parkinson's disease, pheochromocytoma, treatment with MAO inhibitors, peptic ulcer of the stomach and duodenum, erosive gastritis, ulcerative colitis, angina pectoris, chronic heart failure, severe bradycardia, AV blockade, intraventricular blockade, recent myocardial infarction, arterial hypotension, severe cerebral atherosclerosis, Addison's disease, hypokalemia, hyponatremia, hypochloremia, hyperuricemia with clinical manifestations, glaucoma, hematopoietic disorders, bronchial asthma, severe liver and kidney failure (creatinine clearance below 30 ml / min), nephritis, uremia, nephrosclerosis. Pregnancy, lactation period. Childhood. With caution: elderly patients, patients with diabetes mellitus and gout. CompositionComposition of active ingredients in 1 dragee: Clopamid - 5.0 mg Dihydroergocristine - 0.5 mg in the form of dihydroergocristine methane sulfonate - 0.58 mg Reserpine - 0.1 mg Excipients: lactose, potato starch, povidone, talc, magnesium stearate, sucrose, gum arabic, a mixture of white beeswax (E901) and carnauba wax (E903). Overdose Symptoms of drug overdose: nausea, vomiting, diarrhea, headaches, feeling hot and thirsty, hypokalemia, myasthenia gravis, bradycardia, hypotension, heart rhythm disturbances, depression, disturbances of consciousness (confusion), coma, gastric lavage may be useful soon after an overdose and the use of activated charcoal to remove unabsorbed drug from the body. It is necessary to monitor cardiac function, blood pressure and fluid and electrolyte balance and carry out symptomatic treatment, if necessary. Side effectsUsually the drug is easily tolerated. From the nervous system: Myasthenia gravis, weakness, headache, dizziness, drowsiness, weakness, anxiety, impaired concentration, insomnia, extrapyramidal disorders (tremor, stupor, Parkinson's syndrome). Since the drug contains reserpine, one should be aware of the possibility of depressive reactions (including tendencies to suicide) and depressive syndrome when using reserpine at a dose of 1 mg per day (10 tablets of Normatens). From the gastrointestinal tract: Nausea, vomiting, dry mouth, abdominal pain, diarrhea, exacerbation of peptic ulcer, loss of appetite; in isolated cases - the appearance of ulcers on the mucous membrane of the stomach and duodenum, gastrointestinal bleeding when using reserpine at a dose of 1 mg per day (10 tablets of Normatens). From the side of the cardiovascular system: Orthostatic hypotension, bradycardia, cerebrovascular disorders. On the part of the respiratory system: Rhinitis, hyperemia and swelling of the nasal mucosa, the appearance of bronchospasm in patients with bronchial asthma or broncho-obstructive syndrome. From the hemopoietic system: Thrombocytopenia with symptoms of hemorrhagic diathesis. Violation of the water and electrolyte balance in the form of hypokalemia, an increase in the concentration of glucose and uric acid in the blood. Allergic reactions: skin rash, itching. Laboratory indicators: hypokalemia, hypomagnesemia, hypocalcemia, metabolic alkalosis, hyperuricemia, hyperglycemia, a slight increase in triglycerides, cholesterol. Others: galactorrhea. With prolonged use in high doses - paresthesia, decreased libido, reduced potency, gynecomastia, impaired urination, spasm of accommodation, conjunctival hyperemia, hypothermia. Storage conditionsStore in the original packaging, at a temperature not exceeding 25°C. Do not use the drug after the expiration date indicated on the package. The drug should be stored out of reach and hidden from children. Buy Normatens dragee No. 20x1 Price for Normatens dragee No. 20x1
INN | RESERPIN+DIHYDROERGOCRISTIN+CLOPAMIDE |
---|---|
The code | 326 |
Barcode | 4 019 338 605 562 |
Active substance | Reserpine, dihydroergocristine mesylate, clopamide |
Manufacturer | ICN Polfa Rzeszow, Poland |
Importer | Commercial private unitary enterprise "Capsipharm", 223016 Minsk district, Novodvorsky s / s, 6-18; LLC "LIGMATON", Republic of Belarus, Minsk region, Minsk district, Senitsky s / s, 68/3-3, Senitsa district., 223056; PTCHUP "Novamedica" Minsk, 223017 Minsk district, Gatovo village, Metallurgical street, 16a-3; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, room 1; LLC "Iskamed", Republic of Belarus, 220036, Minsk, K. Liebknekhta st., 70, room 6 |
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