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Active ingredients
Dihydroergocristine + Klopamid + Reserpine
Release form
Coated pills
Composition
1 tablet contains: Active ingredient: 100 g reserpine, 5 mg clopamide, dihydroergocristine mesylate is 580 mg, which corresponds to content 500 dihydroergocristine mkg.Vspomogatelnye substances: lactose monohydrate - 44.9 mg potato starch - 24,795 mg Povidone - 2.5 mg Talc - 2.5 mg, magnesium stearate - 0.875 mg. The composition of the shell: crystalline sucrose - 44.80625 mg, acacia gum - 2.1375 mg, talc - 22.8875 mg, macrogol 6000 - 0.16875 mg.
Pharmacological effect
Normatens is a combined antihypertensive drug that contains 3 mutually complementary components. Reserpin – sympatholytic, penetrating into presynaptic endings of postganglionic sympathetic fibers, releases norepinephrine from vesicles with simultaneous disruption of its reverse transport and enhancement of the process of inactivation of MAO. It causes depletion of neurotransmitter stocks and a persistent decrease in blood pressure. It helps to reduce the concentration in the neurons of dopamine, serotonin and other neurotransmitters, providing an antipsychotic effect. Weakens the effect of sympathetic innervation on the cardiovascular system, reduces heart rate and round neck; retains the activity of the parasympathetic nervous system; deepens and enhances physiological sleep, inhibits interoreceptive reflexes. Increases the motility of the gastrointestinal tract, increases production in the stomach of hydrochloric acid; slows down metabolic processes in the body; inhibits and deepens respiratory movements, causes miosis, hypothermia; reduces the intensity of metabolism. It has a positive effect on lipid and protein metabolism in patients with arterial hypertension and coronary atherosclerosis; increases renal blood flow, strengthens glomerular filtration. Clopamide is a looped sulfanilamide diuretic of moderate action, blocks reabsorption of sodium ions at the level of the cortical segment of the loop of Henle, removes sodium, potassium, chlorine and water ions. Dihydroergocristin - a digestive alkaloid ion is active, it is active, it is blocked by the body, it is blocked by the body, it is blocked. dilation of blood vessels, reduces the total peripheral vascular resistance. The antihypertensive effect of the drug exceeds the hypotensive effect of each of the components separately and today Wie any combination of two components; the onset of action is 4-7 days, a persistent hypotensive effect is achieved in 1-4 weeks.
Pharmacokinetics
Absorption The individual components of Normatens are absorbed after ingestion as follows: reserpine by about 30-40%, clopamide - about 90% and dihydroergocristin - less than 25%. Cmax in the blood plasma is achieved accordingly: for reserpine - 1-3 hours, for clopamide - about 2 hours, for dihydroergocristine - about 1 hour. Distribution Certain Normatens individual components are easily distributed in the body (for example, for dihydroergocristine Vd is 52 l / kg). Communication with plasma proteins: for reserpine - does not bind, clopamide - about 46%, dihydroergocristin - about 68%. Reserpine and dihydroergocristine penetrate through the BBB and through the placental barrier. Metabolism Reserpine and dihydro Ergocristine are extensively metabolized in the liver to inactive metabolites. Clopamide does not undergo significant metabolism in the liver. Excretion of T1 / 2 Normatens is long due to the presence of reserpine, for which T1 / 2 is 4.5 hours in the first phase, and about 271 hours in the second. The route of excretion is different for individual components: reserpine and dihydroergocristine - inactive metabolites are excreted in the urine and feces, clopamide, mainly by the kidneys.
Indications
Arterial hypertension.
Precautionary measures
Do not exceed the recommended dose. With caution: diabetes, gout, old age.
Use during pregnancy and lactation
Since reserpine has a teratogenic effect, the use of the drug Normatens during pregnancy is not recommended. In addition, reserpine can cause dangerous for the fetus arterial hypotension, bradycardia. In newborns, reserpine may contribute to the development of rhinorrhea and edema of the nasal mucosa, which leads to difficulty breathing and cyanosis. Clopamide can cause thrombocytopenia in the fetus. The drug should not be used during lactation. This is mainly due to the penetration of reserpine and dihydroergocristine into milk. Dihydroergocristin can cause symptoms in newborns that resemble ergot poisoning, and in mother inhibit / weaken lactation.
Dosage and administration
Normatens is a combined antihypertensive drug that contains 3 mutually complementary components. Reserpin – sympatholytic, penetrating into presynaptic endings of postganglionic sympathetic fibers, releases norepinephrine from vesicles with simultaneous disruption of its reverse transport and enhancement of the process of inactivation of MAO. It causes depletion of neurotransmitter stocks and a persistent decrease in blood pressure.It helps to reduce the concentration in the neurons of dopamine, serotonin and other neurotransmitters, providing an antipsychotic effect. Weakens the effect of sympathetic innervation on the cardiovascular system, reduces heart rate and round neck; retains the activity of the parasympathetic nervous system; deepens and enhances physiological sleep, inhibits interoreceptive reflexes. Increases the motility of the gastrointestinal tract, increases production in the stomach of hydrochloric acid; slows down metabolic processes in the body; inhibits and deepens respiratory movements, causes miosis, hypothermia; reduces the intensity of metabolism. It has a positive effect on lipid and protein metabolism in patients with arterial hypertension and coronary atherosclerosis; increases renal blood flow, strengthens glomerular filtration. Clopamide is a looped sulfanilamide diuretic of moderate action, blocks reabsorption of sodium ions at the level of the cortical segment of the loop of Henle, removes sodium, potassium, chlorine and water ions. Dihydroergocristin - a digestive alkaloid ion is active, it is active, it is blocked by the body, it is blocked by the body, it is blocked. dilation of blood vessels, reduces the total peripheral vascular resistance. The antihypertensive effect of the drug exceeds the hypotensive effect of each of the components separately and today Wie any combination of two components; the onset of action is 4-7 days, a persistent hypotensive effect is achieved in 1-4 weeks.
Overdose
Symptoms: nausea, vomiting, diarrhea, muscle weakness, dizziness, headache, marked reduction in blood pressure, bradycardia, arrhythmias, depression, hyporeflexia, confusion and coma. Treatment: as a first aid, if the patient is conscious, should induce vomiting, do gastric lavage or give activated charcoal. Symptomatic therapy aimed at maintaining the function of the cardiovascular system, correction of electrolyte balance. Reserpine, which is part of the Normatens, is not removed from the body through dialysis.
Interaction with other drugs
Reduces the effectiveness of oral hypoglycemic drugs, tricyclic antidepressants, anticoagulants. Improves the concentration of lithium in the blood plasma (slowing its excretion). Reduces the effect of antiepileptic drugs and levodopa, holinoblokatorov, reduces the analgesic effect of morphine. ,antihistamine drugs. Strengthens the action of adrenomimetik. Barbiturates, ethanol, beta-blockers, peripheral vasodilators strengthen the hypotensive effect. effects on the central nervous system. Against the background of drug treatment, MAO inhibitors cause mild or m severe arterial hypertension, hyperreflexia. Antiarrhythmic drugs - in case of hypokalemia, which may accompany treatment, the risk of the toxic action of amiodarone, disopyramide, quinidine increases; hypokalemia weakens the effect of lidocaine, meksiletina. Combination with dopamine is not recommended (increased vasoconstrictor reaction). When used together with digoxin, the risk of bradycardia increases; in the case of hypokalemia, which may accompany treatment, the risk of increased side effects of digoxin is increased.
special instructions
Since the effect of Normatens develops relatively slowly, the dosage should not be increased more than once a week, due to the possibility of a pronounced decrease in blood pressure; special care must be taken when used with other antihypertensive drugs; during treatment, periodically monitor blood pressure levels to determine the optimal dosing regimen. During treatment, glucose and uric acid levels in the blood serum may increase, it is recommended to periodically monitor these parameters, especially in patients with impaired glucose tolerance and hyperuricemia. Renal function control is necessary, especially in patients with chronic renal failure. In the event of bradycardia during the treatment period, the dose of the drug must be reduced or eliminated. In Treatment time requires control of potassium in the serum. In most patients, additional administration of potassium preparations is not required, provided that the diet contains a sufficient amount of foods rich in potassium (fruits, vegetables, fish, low-fat cheese, etc.). Care should be taken in patients with bronchial asthma and bronchospasms,in case of exacerbation, it is necessary to stop taking Normatensa. Not less than 2 weeks before the planned surgical intervention, you should stop taking the drug and replace it with another antihypertensive agent. drugs interacting with it. 7 days before the start of electroconvulsive therapy, Normatens should be canceled. The effect on the ability drive vehicles and work with mechanisms Normatens can impair the patient's ability to react quickly, especially at the beginning of treatment. During the period of treatment, you should not drive vehicles and engage in any activities that require high concentration of attention and speed of psychomotor reactions.