Normatens®
AiCn Polfa Rzeszow
1266 Items
2019-09-19
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Clinical Pharmacology
Normatens is a combined antihypertensive drug, containing in its composition 3 mutually complementary components.
Reserpine
Sympatolitic, penetrating into the presynaptic endings of postganglionic sympathetic fibers, releases norepinephrine from vesicles while simultaneously disrupting its reverse transport and enhancing the inactivation process of MAO. It causes depletion of neurotransmitter stocks and persistent reduction 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 the 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, increases glomerular filtration.
Klopamid
The "loopback" sulfanilamide diuretic of medium intensity, blocks the reabsorption of sodium ions at the level of the cortical segment of the loop of Henle, removes sodium, potassium, chlorine and water ions.
Dihydroergocristine
Dehydrated ergot alkaloid, blocks alpha-adrenoreceptors, causes dilation of blood vessels, reduces total peripheral vascular resistance. The hypotensive effect of the drug exceeds the hypotensive effect of each of the components separately and the effect of any combination of the two components; the onset of action is 4-7 days, a persistent hypotensive effect is achieved in 1-4 weeks.
Indications
Arterial hypertension.
Composition
Active substance:
Reserpine - 100 mcg.
Clopamide - 5 mg.
Dihydroergocristine mesilate - 580 mcg.
What corresponds to the content of dihydroergocristine - 500 mg.
Excipients:
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:
Crystalline sucrose - 44.80625 mg, acacia gum - 2.1375 mg, talc - 22.8875 mg, macrogol 6000 - 0.16875 mg.
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Dosage and Administration
Adminster orally, during or right after food, without chewing, washing down with a small amount of liquid.
Dose set individually. It is recommended to start treatment with 1 tablet 1 time / day. If necessary (lack of a satisfactory therapeutic effect), the dose of Normatens can be increased up to 2 times / day. (every 12 hours) 1 tablet, and only in exceptional cases - up to 3 times / day. (every 8 hours) 1 tablet.
The maximum daily dose is 3 pills
Adverse reactions
From the digestive system:
Diarrhea, dry mouth, abdominal pain, nausea, vomiting, exacerbation of peptic ulcer disease, loss of appetite.
Rarely, ulceration of the mucous membrane of the stomach and duodenum, gastrointestinal bleeding when using reserpine in a dose higher than 1 mg / day (the amount contained in 10 pills of Normatsens).
Since the cardiovascular system:
Bradycardia, lowering blood pressure, cerebrovascular disorders, orthostatic hypotension
From the side of the central nervous system:
Headache, Dizziness, drowsiness, weakness, anxiety, impaired concentration, Insomnia Extrapiramidal syndromes (tremor, stupor, Parkinson's syndrome).
Since the preparation contains reserpine, one should be aware of the possibility of the occurrence of depressive reactions (including suicidal tendencies) and the 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 pills of Normatsens).
On the part of the respiratory system:
Hyperemia and edema of the nasal mucosa. Reserpine can cause symptoms of bronchospasm, however, this action appears rarely, and, as a rule, in patients with bronchial asthma or broncho-obstructive syndrome.
Allergic reactions:
Skin rash, itching.
From the side of blood-forming organs:
Thrombocytopenia with symptoms of hemorrhagic diathesis.
Laboratory indicators:
Hypokalemia, hypomagnesemia, hypocalcemia, metabolic alkalosis, hyperuricemia, hyperglycemia, a slight increase in the content of triglycerides, cholesterol.
Other:
Galactorrhea.
With prolonged use in high doses:
Paresthesia, decreased libido, decreased potency, gynecomastia, impaired urination, accommodation spasm, conjunctival hyperemia, hypothermia.
Contraindications
Carefully:
- Diabetes.
- Gout.
- Elderly age.
Drug interactions
Reduces the effectiveness of oral hypoglycemic drugs, tricyclic antidepressants, anticoagulants.
Increases the concentration of lithium in the blood plasma (slowing its excretion).
Weakens the effect of antiepileptic drugs and levodopa, anticholinergic blockers, reduces the analgesic effect of morphine.
Enhances the effect of barbiturates, ethanol, drugs for inhalation anesthesia, antihistamine drugs.
Strengthens action of adrenergic.
Barbiturates, ethanol, beta-blockers, peripheral vasodilators enhance the hypotensive effect.
Glucocorticosteroids, nonsteroidal anti-inflammatory drugs, laxative drugs reduce the diuretic, hypotensive effects, increase the risk of hypokalemia.
Against the background of treatment with MAO inhibitors - strengthening the inhibitory effect on the central nervous system.
On the background of drug treatment, MAO inhibitors cause moderate or severe arterial hypertension, hyperreflexia.
Antiarrhythmic drugs - in the case of hypokalemia, which may accompany treatment, the risk of the toxic action of amiodarone, disopyramide, quinidine increases; hypokalemia weakens the effect of lidocaine, meksiletin.
Combination with dopamine is not recommended (increased vasoconstrictor reaction).
When combined 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.
Pregnancy and Lactation
Since reserpine has a teratogenic effect, the use of Normatens during pregnancy is not recommended.
In addition, reserpine can cause dangerous to 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.
Dihydroergocristine may cause symptoms in newborns resembling ergot poisoning, and in the mother inhibit / weaken lactation.
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 must be taken when used with other antihypertensive drugs; during treatment, periodically monitor blood pressure levels to determine the optimal dosing regimen.
During treatment, the level of glucose and uric acid in the serum may increase, it is recommended to periodically monitor these parameters, especially in patients with impaired glucose tolerance and hyperuricemia.
The control of renal function is necessary, especially in patients with chronic renal failure.
In the case of bradycardia during the treatment period, the dose of the drug must be reduced or canceled.
During treatment, control of potassium in the blood serum is necessary. 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 must be taken in patients with asthma and bronchospasm, in case of exacerbation, it is necessary to stop taking Normatsens.
At least 2 weeks before the planned surgery, you should stop taking the drug and replace it with another antihypertensive.
During treatment should not drink alcohol.
The dose of Normatens should be accordingly modified in case of simultaneous use of other drugs interacting with it.
7 days before the start of electroconvulsive therapy, Normatens should be canceled.
Influence on ability to drive motor transport and control mechanisms
Normatens may impair the patient's ability to respond quickly, especially at the beginning of treatment. During the period of treatment, you should not drive vehicles and engage in any activities that require increased concentration and psychomotor reactions.
Overdosage
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 a 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 Normatensa, is not excreted from the body through dialysis.
- Brand name: Normatens
- Active ingredient: Dihydroergocristine, Clopamide, Reserpine
- Dosage form: Pills.
- Manufacturer: AiCn Polfa Rzeszow
- Country of Origin: Poland
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