Normatens, pills 20pcs

Composition

Auxiliary substances:

lactose monohydrate – 44.9 mg,

potato starch-24.795 mg,

povidone-2.5 mg,

talc-2.5 mg,

magnesium stearate-0.875 mg.

Shell composition:

crystal sucrose-44.80625 mg, acacia gum-2.1375 mg, talc-22.8875 mg, macrogol 6000-0.16875 mg

Pharmacological action

Clinical and pharmacological group: Antihypertensive drugpharmacotherapy group: Antihypertensive combination drug (sympatholytic+alpha-blocker+diuretic)Pharmacological action Normatens is a combined antihypertensive drug that contains 3 complementary components in its composition. Reserpine-sympatholytic, penetrating into the presynaptic endings of postganglionic sympathetic fibers, releases norepinephrine from vesicles with simultaneous disruption of its reverse transport and increased MAO inactivation. Causes depletion of neurotransmitter reserves and a persistent decrease in blood pressure. Helps reduce the concentration of dopamine, serotonin and other neurotransmitters in neurons, having an antipsychotic effect. Weakens the influence of sympathetic innervation on the cardiovascular system, reduces heart rate and OPSS; preserves the activity of the parasympathetic nervous system; deepens and enhances physiological sleep, slows down interoreceptive reflexes. Increases peristalsis of the gastrointestinal tract, increases the production of hydrochloric acid in the stomach; slows down metabolic processes in the body; reduces 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, increases glomerular filtration. Clopamide is a “loop” sulfonamide diuretic of medium strength, blocks the reabsorption of sodium ions at the level of the cortical segment of the Henle loop, removes sodium, potassium, chlorine and water ions. Dihydroergocristine is a dihydrogenated ergot alkaloid that blocks alpha-adrenergic receptors, causes vasodilation, and reduces total peripheral vascular resistance. The antihypertensive effect of the drug exceeds the antihypertensive effect of each of the components separately and the effect of any combination of two components; the onset of action is 4-7 days, a persistent antihypertensive effect is achieved after 1-4 weeks. Pharmacokineticsabsorption The individual components of Normatens are absorbed after oral use as follows: reserpine by approximately 30-40%, clopamide – about 90% and dihydroergocristine – less than 25%. Cmax in blood plasma is achieved, respectively: for reserpine – 1-3 hours, for clopamide – about 2 hours, for dihydroergocristine – about 1 h. Distribution The individual components of Normatens are easily distributed in the body (for example, for dihydroergocristine Vd is 52 l/kg). Binding to plasma proteins: for reserpine – does not bind, clopamide-about 46%, dihydroergocristine-about 68%. Reserpine and dihydroergocristine penetrate the BBB and the placental barrier. Metabolism Reserpine and dihydroergocristine are extensively metabolized in the liver to inactive metabolites. Clopamide is not significantly metabolized in the liver. The elimination of 1/2 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 elimination 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.

Use during pregnancy and lactation

Since reserpine has a teratogenic effect, it is not recommended to use Normatens during pregnancy. In addition, reserpine can cause dangerous fetal hypotension, bradycardia. In newborns, reserpine can contribute to rhinorrhea and swelling of the nasal mucosa, which leads to breathing difficulties and cyanosis. Clopamide may 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. Dihydroergocristine can cause symptoms similar to ergot poisoning in newborns, and inhibit / weaken lactation in the mother.

Contraindications

• Hypersensitivity to any of the components of the drug.
• Depression
• Epilepsy.
• Parkinson’s disease
• Concomitant electroconvulsive therapy.
• Pheochromocytoma.
• Concomitant treatment with monoamine oxidase (MAO) inhibitors.
• Peptic ulcer of the stomach and duodenum in the acute phase.
• Erosive gastritis.
• Non-specific ulcerative colitis.
• Angina pectoris.
• Recently suffered a myocardial infarction.
• Chronic heart failure.
• Severe bradycardia.
• Atrioventricular block.
• Intraventricular block.
• Severe renal insufficiency (creatinine clearance below 30 ml / min).
• Jade.
• Uremia.
• Nephrosclerosis.
• Arterial hypotension.
• Severe cerebral atherosclerosis.
• Severe liver function disorders.
• Addison’s disease.
• Hypokalemia.
• Hyponatremia.
• Hypochloremia.
• Hyperuricemia with clinical manifestations.
• Angle-closure glaucoma.
• Violation of hematopoiesis.
• Pregnancy.
• Lactation period.
• Bronchial asthma.
• Age up to 18 years (efficacy and safety of use have not been established).

With caution:

• Diabetes mellitus.
• Gout.
• Advanced age.

Side effects

From the digestive system: diarrhea, dry mouth, abdominal pain, nausea, vomiting, exacerbation of peptic ulcer disease, decreased appetite. Rarely – ulceration of the gastric and duodenal mucosa, gastrointestinal bleeding when using reserpine at a dose higher than 1 mg / day (the amount contained in 10 tablets). Normatence). From the cardiovascular system: bradycardia, decreased blood pressure, cerebrovascular disorders, orthostatic hypotension. From the central nervous system: headache, dizziness, drowsiness, weakness, anxiety, impaired concentration, insomnia, extrapyramidal disorders (tremor, stupor, Parkinson’s syndrome);Since the drug contains reserpine, you should be aware of the possibility of depressive reactions (including suicidal tendencies) and depressive syndrome; such symptoms appear rarely and only in cases of using large doses of reserpine (more than 1 mg/day, which corresponds to the content of reserpine in more than 10 tab. Normatence). From the respiratory system: hyperemia and swelling of the nasal mucosa. Reserpine may cause symptoms of bronchospasm, but this effect is rare, and usually occurs in patients with bronchial asthma or bronchial obstructive syndrome. Allergic reactions: skin rash, pruritus. Hematopoietic disorders: thrombocytopenia with symptoms of hemorrhagic diathesis. Laboratory parameters: hypokalemia, hypomagnesemia, hypocalcemia, metabolic alkalosis, hyperuricemia, hyperglycemia, slight increase in triglycerides, cholesterol. Other: galactorrhea. With prolonged use in high doses – paresthesia, decreased libido, decreased potency, gynecomastia, impaired urination, spasm of accommodation, conjunctival hyperemia, hypothermia.

Interaction

Reduces the effectiveness of oral hypoglycemic medications, tricyclic antidepressants, and anticoagulants. Increases the concentration of lithium in the blood plasma (slowing its excretion). Weakens the effect of antiepileptic drugs and levodopa, holinoblokatorov, reduces the analgesic effect of morphine. Increases the effect of barbiturates, ethanol, drugs for inhalation anesthesia, antihistamines. Increases the effect of adrenomimetics. Barbiturates, ethanol, beta-blockers, and peripheral vasodilators enhance the hypotensive effect. Glucocorticosteroids, nonsteroidal anti-inflammatory drugs, and laxatives reduce diuretic and hypotensive effects, and increase the risk of hypokalemia. Against the background of treatment with MAO inhibitors – increased depressive effect on the central nervous system. MAO inhibitors cause moderate to severe arterial hypertension and hyperreflexia during treatment with the drug. Antiarrhythmic agents – in the case of hypokalemia, which may accompany treatment, the risk of toxic effects of amiodarone, disopyramide, quinidine increases; hypokalemia weakens the effect of lidocaine, mexiletine. Combination with dopamine (increased vasoconstrictor response) is not recommended. When combined with digoxin, the risk of bradycardia increases; in the case of hypokalemia, which may accompany treatment, the risk of increased digoxin adverse reactions increases.

How to take it, course of use and dosage

Inside, during or immediately after a meal, without chewing, with a small amount of liquid. The dose is set individually. It is recommended to start treatment with 1 tab.1 time/day, if necessary (no satisfactory therapeutic effect), you can increase the dose of the drug up to 2 times/day (every 12 hours) for 1 tab., and only in exceptional cases-up to 3 times/day (every 8 hours) for 1 tab.. The maximum daily dose is 3 tablets. Due to the mechanism of action of the drug, the possible lack of effectiveness of the drug can be said no earlier than 2 weeks after the start of use, so during this period you should not unnecessarily increase the initial dose. With long-term treatment, in case of a satisfactory therapeutic effect, it is recommended to take 1 tab. 1 time/day, and in some patients the dose of the drug can be reduced to 1 tab. 1 time every other day. Blood pressure monitoring is necessary for each dose reduction. During maintenance therapy, the dose should not exceed 2 tablets/day.

Overdose

Symptoms: nausea, vomiting, diarrhea, muscle weakness, dizziness, headache, marked decrease in blood pressure, bradycardia, arrhythmias, depression, hyporeflexia, confusion and coma. Treatment: as a first aid, if the patient is conscious, you should induce vomiting, do gastric lavage or give activated charcoal. Conducting symptomatic therapy aimed at maintaining the function of the cardiovascular system, correcting the electrolyte balance. Reserpine, which is part of Normatens, is not eliminated from the body by dialysis.

Special instructions

Since the effect of Normatens develops relatively slowly, the dosage should not be increased more often than once a week, due to the possibility of a pronounced decrease in blood pressure; special care should be taken in the case of combined use with other antihypertensive agents; during treatment, periodically monitor the level of blood pressure to determine the optimal dosage regimen. Serum glucose and uric acid levels may increase during treatment, and periodic monitoring of these parameters is recommended, especially in patients with impaired glucose tolerance and hyperuricemia. Monitoring of renal function is necessary, especially in patients with chronic renal failure. If bradycardia occurs during treatment, the dose of the drug should be reduced or discontinued. During treatment, it is necessary to monitor potassium in the blood serum. In most patients, additional potassium supplementation is not required, provided that the diet contains a sufficient amount of foods rich in potassium (fruits, vegetables, fish, low-fat cheese, etc. ). Caution should be exercised in patients with bronchial asthma and bronchospasms, in case of exacerbation, it is necessary to stop taking Normatens. At least 2 weeks before the planned surgical intervention, you should stop taking the drug and replace it with another antihypertensive agent. Do not drink alcohol during treatment. The dose of Normatens should be modified accordingly in the case of concomitant use of other drugs that interact with it. 7 days before the start of electroconvulsive therapy, Normatens should be discontinued. Influence on the ability to drive vehicles and work with mechanisms of Aminormatens can interfere with the patient’s ability to react quickly, especially at the beginning of treatment. During the treatment period, you should not drive vehicles or engage in any activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place, protected from light, at a temperature of 15° to 25°C. Keep out of reach of children.

Shelf life

5 years

Active ingredient

Dihydroergocristine, Clopamide, Reserpine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension