Composition
1 tablet contains:
Active ingredient:
proroxane hydrochloride 0.015 g;
excipients:
lactose monohydrate 0.078 g,
potato starch 0.005 g,
talc 0.001 g,
magnesium stearate 0.001 g.
Pharmacological action
Pharmacotherapeutic group: Alpha-adrenoblocker ATX code: C02SPharmacodynamics : Proroxan has antihypertensive and antipruritic effects. Blocks postsynaptic alpha-1 and presynaptic alpha-2 adrenergic receptors, regardless of their location. It has a peripheral and central influence. Reduces the sensitivity of adrenoreceptors to adrenaline by changing the permeability of cell membranes. Reduces the intensity of stimulation of hypothalamic structures by reducing the release of tropic hormones of peripheral gland hormones. Reduces the transmission of adrenergic vasoconstrictor impulses eliminates spasm and dilates peripheral vessels, especially arterioles and precapillaries. Improves blood supply to the muscles of the skin and mucous membranes. It suppresses the excitability of the brain’s diencephalic structures and regulates the tone of the sympathoadrenal system. Pharmacokinetics:
When taken orally, proroxan is well absorbed in the gastrointestinal tract, the effective concentration is reached in 30-40 minutes and persists for 3-4 hours. Binding to plasma proteins is weak. The drug has a large volume of distribution, it quickly penetrates into various tissues and fluids, including the cerebrospinal fluid.
It penetrates well through histohematic barriers, including the blood-brain barrier. It is selectively delayed in the hypothalamus, the posterior region of which contains mainly noradrenergic neurons. It is mainly excreted by the kidneys. About 70% of the administered dose is excreted by the kidneys in the first 24 hours.
In animal experiments with intraperitoneal use, the elimination half-life was not established, while less than 5% of the administered dose of the drug remained in the blood plasma 1 hour after use, and only traces remained after 2 hours. In the brain,22% of the maximum concentration was detected after 1 hour, and 6% of the maximum concentration was detected after 2 hours. Also, in experiments with carbon-labeled proroxane, it was shown that the products of its metabolism can linger for a long time (up to 10 days) in various organs and tissues (plasma, brain, liver, kidneys).
Indications
-Somatoform autonomic dysfunction occurring according to the sympathoadrenal type, including with increased blood pressure (as a symptomatic agent in complex therapy);
– allergic dermatitis (as a symptomatic agent in complex therapy for relieving itching).
Use during pregnancy and lactation
The use of Vegetrox® is contraindicated during pregnancy and lactation due to insufficient data on efficacy and safety.
Contraindications
– Hypersensitivity to the Active ingredient and auxiliary components of the drug;
– ischemic heart disease (II-IV functional class);
– circulatory failure II-III degree;
– arterial hypotension;
– cardiogenic shock;
– bradycardia;
myocardial infarction;
severe atherosclerosis;
– severe cerebrovascular disease (including stroke, transient ischemic attack in the anamnesis);
– age under 18 years (effectiveness and safety not established);
– deficiency of lactase, lactose intolerance syndrome glucose-galactose malabsorption.
With caution:
Advanced age coronary heart disease arrhythmia gastric ulcer.
It is recommended to monitor the concentration of glucose in the blood (possibly an increase in the level of endogenous insulin).
Side effects
the incidence of adverse reactions listed as classified by the world health organization (who): very often – more often 1/10 – 1/100 and less than 1/10 of infrequently – less than 1/1000 and 1/100 rarely more than and less than 1/1000 1/10000 very rarely – less than 1/10000; the frequency is unknown (according to the available data to determine the frequency of development is not possible).
From the cardiovascular system: Â frequency unknown-arterial hypotension bradycardia occurrence of angina attacks in predisposed patients orthostatic hypotension arrhythmias dizziness hyperemia of the skin nasal congestion.
From the gastrointestinal tract: Â frequency unknown – diarrhea increased secretion of hydrochloric acid in the stomach.
From the side of the skin: Â frequency unknown-allergic reactions.
If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.
Interaction
Simultaneous use of proroxan and epinephrine may lead to a decrease in the effectiveness of the latter (the development of a depressive effect instead of a pressor one). Simultaneous use with antihypertensive agents leads to a mutual increase in the effect of lowering blood pressure.
Increases the effect of neuroleptics (derivatives of phenothiazine butyrophenone diphenylbutylpiperidine thioxanthene).
Against the background of joint use with novocainamide, a decrease in the stroke volume of the heart is possible.
How to take, course of use and dosage
With somatoform autonomic dysfunction occurring according to the sympathoadrenal type, as part of complex therapy,15-30 mg (1-2 tablets) is prescribed orally 2-3 times a day. The duration of treatment is determined by the attending physician.
For allergic dermatitis as part of complex therapy, it is recommended to prescribe 15-30 mg (1-2 tablets) orally before bedtime. The duration of treatment is determined by the attending physician.
Overdose
Symptoms: Â bradycardia sharp decrease in blood pressure orthostatic collapse.
Treatment: Â symptomatic treatment aimed at maintaining vital functions.
Description
Round biconvex tablets are white or white with a yellowish tinge of color.
Special instructions
Features of the drug’s action at the first dose:
When taking the first dose of the drug, there may be a sharp drop in blood pressure fainting headache weakness palpitations and deterioration of the subjective state (“first dose phenomenon”). this is not a reason to cancel the drug, since this effect disappears with repeated use. Also note drowsiness and a rapidly passing sensation of numbness of the tongue. In addition, it is recommended to monitor the concentration of glucose in the blood due to the possible increase in the level of endogenous insulin. Therefore, it is necessary to start treatment under the supervision of a doctor with the minimum effective dose and observe bed rest after taking the drug for 6-8 hours.
Influence on the ability to drive vehicles and mechanisms:
During treatment with the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Storage conditions
Store in a dark place at a temperature not exceeding 30°C.
Keep out of the reach of children.
Shelf
life is 3 years. Do not use after the expiration date.
Active ingredient
Proroxan
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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Side effects of Vegetrox pills 15mg, 10pcs.
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