Normatens
Normatens: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Normatens
ATX code: C02LA51
Active ingredient: reserpine (reserpine), clopamide (clopamide), dihydroergocristine (dihydroergocristine)
Producer: ICN POLFA RZESZOW, SA (Poland)
Description and photo update: 2018-25-10
Prices in pharmacies: from 117 rubles.
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Normatens is an antihypertensive combination drug.
Release form and composition
Dosage form Normatens - film-coated tablets: round, biconvex, with a smooth surface, almost white or white (in a blister 20 pcs., In a cardboard box 1 or 2 blisters).
Composition of one tablet:
- active ingredients: clopamide - 5 mg; dihydroergocristine (in the form of dihydroergocristine mesylate) - 0.5 mg; reserpine - 0.1 mg;
- auxiliary components (core): potato starch, lactose monohydrate, povidone, magnesium stearate, talc;
- shell: crystalline sucrose, macrogol 6000, talc, acacia gum.
Pharmacological properties
Pharmacodynamics
Normatens is a combined preparation containing three active components that have antihypertensive effects and complement each other.
Clopamide is a medium-strength sulfonamide loop diuretic. Due to the inhibition of active reabsorption of sodium ions in the cortical segment of the ascending part of Henle's loop, as well as inhibition of carbonic anhydrase in the proximal part of the convoluted tubules, it causes increased diuresis and excretion of sodium, potassium, and chlorine ions in the urine. It helps to reduce the initially high blood pressure (blood pressure), improve venous tone.
Dihydroergocristine mesylate belongs to the dihydrogenated ergot alkaloids. It blocks alpha-adrenergic receptors, reduces systemic vascular resistance (total peripheral vascular resistance), and causes vasodilation.
Reserpine, being an alkaloid of rauwolfia, has antihypertensive, sympatholytic and neuroleptic effects. Penetrating into the presynaptic nerve endings of postganglionic sympathetic fibers, it releases norepinephrine from the vesicles, simultaneously disrupting its reverse transport and enhancing the process of inactivation of monoamine oxidase (MAO). Reserpine, causing the depletion of neurotransmitter stores, provides a persistent decrease in blood pressure; helps to reduce the concentration of serotonin, dopamine and other neurotransmitters in neurons, thereby providing an antipsychotic effect; reduces the effect of sympathetic innervation on the cardiovascular system, lowers heart rate (heart rate) and systemic vascular resistance, maintains the activity of the parasympathetic nervous system, helps inhibition of interoceptive reflexes, enhances and deepens physiological sleep. Reserpine helps to increase the peristalsis of the gastrointestinal tract, increase the formation of hydrochloric acid in the stomach; slowing down metabolic processes, reduces the metabolic rate in the body; deepens and reduces respiratory movements, causes hypothermia, miosis. In addition, reserpine has a positive effect on protein and lipid metabolism in patients with arterial hypertension and coronary atherosclerosis, increases renal blood flow and glomerular filtration.reserpine has a positive effect on protein and lipid metabolism in patients with arterial hypertension and atherosclerosis of the coronary arteries, increases renal blood flow and glomerular filtration.reserpine has a positive effect on protein and lipid metabolism in patients with arterial hypertension and atherosclerosis of the coronary arteries, enhances renal blood flow and glomerular filtration.
The antihypertensive effect of Normatens is superior to the antihypertensive effect of each of its components separately and any combination of the two components. The drug begins to act on the 4-7th day, a persistent hypotensive effect is established after 1-4 weeks.
Pharmacokinetics
- absorption: after taking the drug orally in the gastrointestinal tract, approximately 90% of clopamide is absorbed, less than 25% of dihydroergocristine, about 30–40% of reserpine. The maximum concentration in blood plasma (C max) is achieved for clopamide in about 2 hours, for dihydroergocristine - 1 hour, for reserpine - 1–3 hours;
- distribution: the active components of Normates are well distributed in organs and tissues (for example, the volume of distribution of dihydroergocristine is 52 l / kg); about 46% of clopamide and about 68% of dihydroergocristine bind to plasma proteins, reserpine does not bind to proteins. Dihydroergocristine and reserpine cross the blood-brain barrier and the placenta;
- metabolism: dihydroergocristine and reserpine are extensively metabolized in the liver to form inactive metabolites. Clopamide is not significantly metabolized in the liver;
- excretion: the half-life (T 1/2) of Normates is long due to the presence of reserpine, T 1/2 of which is 4.5 hours in the first phase and about 271 hours in the second. Excretion routes are different: clopamide is excreted mainly by the kidneys, inactive metabolites of dihydroergocristine and reserpine - with feces and urine.
Indications for use
According to the instructions, Normatens is indicated for use in patients with arterial hypertension (primary, secondary).
Contraindications
Absolute:
- epilepsy, depression, Parkinson's disease, simultaneous electroconvulsive therapy;
- severe cerebral atherosclerosis, arterial hypotension;
- erosive gastritis, gastric and duodenal ulcers in the acute phase, ulcerative colitis;
- severe renal dysfunction (creatinine clearance less than 30 ml / min), nephritis, nephrosclerosis, uremia;
- chronic heart failure, angina pectoris, severe bradycardia, recent myocardial infarction, intraventricular block, atrioventricular block;
- severe liver failure;
- hyponatremia, hypokalemia, hypochloremia;
- Addison's disease;
- pheochromocytoma, simultaneous therapy with MAO inhibitors;
- angle-closure glaucoma;
- hyperuricemia with clinical manifestations;
- bronchial asthma;
- disorders of hematopoiesis;
- pregnancy and the period of breastfeeding;
- age up to 18 years;
- individual hypersensitivity to the Normates components.
Relative:
- gout;
- diabetes;
- elderly age.
Instructions for the use of Normates: method and dosage
Normatens tablets are taken orally, swallowing whole with a small amount of liquid, during or immediately after a meal.
The doctor sets the dose individually for each patient.
The following dosage is recommended: at the beginning of treatment - 1 tablet 1 time per day; in the absence of a satisfactory hypotensive effect, you can increase the dose and take 1 tablet up to 2 times a day (with an interval of 12 hours). Only in exceptional cases is it allowed to take the drug up to 3 times a day (with an interval of 8 hours), 1 tablet. The maximum daily dose of Normates is 3 tablets.
Given the mechanism of the pharmacological action of the components of the drug, it is possible to speak about the possible absence of a therapeutic effect no earlier than 2 weeks after the start of treatment, therefore, during this period of time, the initial dose should not be increased without an urgent need.
With prolonged therapy, after a satisfactory therapeutic effect has been achieved, it is recommended to take 1 tablet 1 time per day, and for some patients it is possible to reduce the dose and take 1 tablet 1 time every other day. It is necessary to control blood pressure at each dose reduction of Normates.
In the case of maintenance therapy, the dose of 2 tablets / day should not be exceeded.
Side effects
- cardiovascular system: lowering blood pressure, bradycardia, orthostatic hypotension, cerebrovascular disorders;
- central nervous system (CNS): dizziness, headache, anxiety, weakness, drowsiness, insomnia, impaired concentration, extrapyramidal disorders (including Parkinson's syndrome, stupor, tremor); rarely and only in cases of using a dose of reserpine above 1 mg / day (corresponds to the substance content in more than 10 Normates tablets) - depressive reactions (including tendencies to suicide), depressive syndrome;
- respiratory system: hyperemia and edema of the nasal mucosa. In rare cases, reserpine can cause bronchospasm (in patients with broncho-obstructive syndrome or bronchial asthma);
- digestive system: nausea / vomiting, abdominal pain, dry mouth, diarrhea, decreased appetite, exacerbation of peptic ulcer disease; rarely - cases of ulceration of the mucous membrane of the stomach and duodenum 12, gastrointestinal bleeding when using a dose of reserpine above 1 mg / day (corresponds to the amount contained in 10 or more Normates tablets);
- hematopoietic organs: thrombocytopenia with symptoms of hemorrhagic diathesis;
- allergic reactions: itching, skin rash;
- laboratory parameters: hypocalcemia, hypomagnesemia, hypokalemia, hyperglycemia, hyperuricemia, metabolic alkalosis, a slight increase in cholesterol, triglycerides;
- others: galactorrhea; with prolonged use in large doses - decreased potency, decreased libido, paresthesia, accommodation spasm, urinary disorders, gynecomastia, hypothermia, conjunctival hyperemia.
Overdose
In case of an overdose of Normates, the following symptoms may develop: nausea and / or vomiting, muscle weakness, diarrhea, headache, dizziness, a marked decrease in blood pressure, depression, arrhythmias, bradycardia, confusion, coma, hyporeflexia.
As a first aid for intoxication, if the patient is conscious, it is recommended to provoke vomiting, rinse the stomach and / or take activated charcoal. Further treatment consists in supportive therapy aimed at correcting the water and electrolyte balance and maintaining the functioning of the cardiovascular system.
Reserpine, which is part of Normates, is not excreted from the body by dialysis.
special instructions
In order to prevent an excessive decrease in blood pressure, you should not increase the Normatens dose more than once a week, since the hypotensive effect of the drug is achieved relatively slowly. It is also important to be especially careful in case of simultaneous use with other antihypertensive drugs. To determine the optimal dosage regimen of the drug, periodic monitoring of blood pressure levels during treatment is required.
It is recommended to periodically monitor the level of uric acid and glucose in the blood serum, especially in patients with hyperuricemia and impaired glucose tolerance, since these indicators may increase during the period of drug treatment.
With the development of bradycardia, Normatens should be canceled or its dose should be reduced.
During the treatment period, it is necessary to control the serum potassium concentration. If the patient's diet contains sufficient potassium-rich foods, additional potassium supplementation is usually not required.
When using Normatens in patients with bronchospastic syndrome and bronchial asthma, caution should be exercised. In case of exacerbation of the disease, the drug must be canceled.
It is necessary to monitor the functioning of the kidneys, especially in patients with chronic renal failure.
If surgical intervention is planned, you should stop taking Normatens at least two weeks in advance, replacing it with another antihypertensive agent.
It is not recommended to consume alcoholic beverages during therapy.
It is necessary to take into account the peculiarities of the interaction of the drug when used together with other drugs and modify the dose accordingly.
One week before the start of electroconvulsive therapy, Normatens should be canceled.
Influence on the ability to drive vehicles and complex mechanisms
Due to the fact that Normatens can reduce concentration of attention and the ability to rapid psychomotor reactions (especially at the initial stage of therapy), one should not drive vehicles / other complex mechanisms and engage in hazardous activities associated with the risk of accidents during the period of drug treatment …
Application during pregnancy and lactation
It is not recommended to use Normatens in pregnant women, since the reserpine included in its composition has the property of teratogenic effects on the fetus. In addition, in a newborn, it can provoke the occurrence of rhinorrhea and edema of the nasal mucosa and, consequently, difficulty breathing and cyanosis. Also, as a result of the action of reserpine, arterial hypertension, bradycardia, dangerous for the fetus, can develop.
Clopamide can cause thrombocytopenia in the fetus.
Dihydroergocristine may contribute to the onset of ergot-like symptoms in newborns, and to inhibition / weakening of lactation in the mother.
Reserpine and dihydroergocristine are able to pass into breast milk, so Normatens should not be taken by women who are breastfeeding.
Pediatric use
Since the safety and efficacy of the drug in pediatrics has not been established, it is not recommended to prescribe Normatens to children and adolescents under 18 years of age.
With impaired renal function
Normatens is prohibited for use in patients with severely impaired renal function (creatinine clearance less than 30 ml / min).
For violations of liver function
Patients with severe hepatic impairment are contraindicated to take Normatens.
Use in the elderly
Prescribe the drug to elderly patients with caution.
Drug interactions
- oral hypoglycemic drugs, tricyclic antidepressants, anticoagulants: decrease in their effectiveness;
- antiepileptic drugs, levodopa, anticholinergics: weakening their action;
- morphine: reducing its analgesic effect;
- lithium preparations: increasing the concentration of lithium in the blood plasma (slowing down its excretion);
- barbiturates, ethanol, antihistamines, drugs for inhalation anesthesia: enhancing their action;
- ethanol, barbiturates, peripheral vasodilators, beta-blockers: increased antihypertensive effect;
- non-steroidal anti-inflammatory drugs, glucocorticosteroids, laxatives: a decrease in the diuretic, hypotensive effect, an increased risk of hypokalemia;
- adrenomimetics: enhancing their effect;
- MAO inhibitors: an increase in the inhibitory effect on the central nervous system, an increase in the likelihood of developing hyperreflexia, severe or moderate arterial hypertension;
- antiarrhythmic drugs: with concomitant treatment of hypokalemia - increased risk of toxic effects of quinidine, disopyramide, amiodarone;
- lidocaine, mexiletine; with concomitant treatment of hypokalemia - weakening of their effect;
- dopamine: increased vasoconstrictor response (the combination is not recommended);
- digoxin: increased risk of bradycardia; with concomitant treatment of hypokalemia - increased side effects of digoxin.
Analogs
Acenosin and Kristepin are analogs of Normatens.
Terms and conditions of storage
Store in a dark, dry place at temperatures from 15 to 25 ° C.
Keep out of the reach of children.
Shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Normatens
In reviews of Normatens, they note its high efficiency with prolonged use. Many patients take the drug for several years, which ensures a stable blood pressure level.
In cases where a rapid decrease in blood pressure is required, other medications must be selected.
Price for Normatens in pharmacies
The average price for Normatens is approximately 160 rubles (for a pack of 20 tablets).
Normatens: prices in online pharmacies
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Drug name Price Pharmacy |
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Normatens coated tablets 20 pcs. 117 RUB Buy |
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Normatens tablets p.o. 20 pcs. 135 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
