Instructions Raunatin-Health film-coated tablets 2 mg blister No. 20
Composition
active ingredient: 1 tablet contains Rauwolfia extract (sum of Rauwolfia alkaloids) (Rauwolfia emetica root dry extract (31‒33:1) (extractant: methanol)) 2 mg;
excipients: granulated sugar; corn starch; glucose, monohydrate; calcium stearate; stearic acid; mineral oil; light magnesium carbonate; titanium dioxide (E 171); povidone; talc; colloidal anhydrous silicon dioxide; yellow wax; dye Sykovit Green Z2755, containing quinoline yellow (E 104) and patent blue V (E 131).
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, light green in color, with a biconvex surface. Imperfections are allowed on the surface of the tablets. Three layers are visible in the cross section.
Pharmacotherapeutic group
Antihypertensives. Antiadrenergic agents with a central mechanism of action. Rauwolfia alkaloids. ATC code C02A A04.
Pharmacological properties
Pharmacodynamics
The drug contains the sum of alkaloids from the roots of Rauwolfia spicata or the bark of the roots of Rauwolfia spicata of the family Kutrovye. The alkaloids are represented by reserpine, serpentine, ajmalin. The total content of alkaloids is not less than 90%.
Raunatin has a hypotensive effect due to a decrease in the content of biogenic monoamines (noradrenaline, dopamine, serotonin) in the central nervous system (CNS) (cortico-hypothalamic structures, especially the posterior part of the hypothalamus). By disrupting the processes of mediator deposition in the vesicles of the presynaptic membrane of peripheral adrenergic nerve endings, the vascular wall, and the medulla of the adrenal glands, the drug blocks adrenergic transmission, which leads to a gradual decrease in blood pressure. The hypotensive effect of the drug develops more gradually, unlike reserpine, but is not significantly inferior to reserpine in its severity. A feature of the drug is the increase in glomerular filtration in the kidneys, which leads to an increase in renal blood circulation.
The drug also has antiarrhythmic effects and a calming effect on the central nervous system. The sedative effect of the drug is less pronounced compared to reserpine.
The therapeutic effect of the drug develops gradually by the 10th to 14th day after the start of its use and persists for 2 to 3 months.
In some cases, raunatin is better tolerated than reserpine.
Pharmacokinetics
The alkaloids of the drug are well absorbed from the gastrointestinal tract; Cmax in the blood is observed 1-3 hours after administration. Binding to blood proteins is 40-50%. T½ is 50-170 hours; metabolized in the intestines and liver, excreted mainly with feces, as well as with urine.
Indication
Mild and moderate arterial hypertension.
Contraindication
Hypersensitivity to rauwolfia alkaloids; arterial hypotension, heart failure, organic heart lesions, bradycardia, aortic defects, severe cerebral atherosclerosis, depression, epilepsy, parkinsonism, gastric and duodenal ulcer in the acute stage, ulcerative colitis, nephrosclerosis, bronchial asthma, pheochromocytoma, electroconvulsive therapy (the drug should be discontinued at least 7 days before electroconvulsive therapy).
Interaction with other medicinal products and other types of interactions
When used simultaneously with monoamine oxidase inhibitors (MAO), agitation and arterial hypertension may develop. The antihypertensive effect of raunatin is enhanced when used with other antihypertensive agents (thiazide diuretics, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium ion antagonists). Enhances the CNS depressant effect of alcohol, barbiturates, antidepressants. Digitalis or quinidine preparations when used simultaneously with raunatin may cause arrhythmia. Reduces the effectiveness of antiparkinsonian agents and sympathomimetics.
Application features
Treatment with the drug should be carried out under the supervision of a doctor. In patients with angina pectoris, pain in the heart area may increase.
Before planned surgical interventions, the drug should be discontinued a few days before the operation. In case of emergency surgery under general anesthesia, patients taking Raunatin should be premedicated with atropine.
The drug should not be used before an electropulse therapy session.
Since rauwolfia alkaloids increase motility and secretion in the digestive tract, caution should be exercised when using the drug in patients with a history of peptic ulcer disease.
Caution should also be exercised when using the drug in debilitated and elderly patients; in the presence of renal failure, cholelithiasis, arrhythmia, and in patients who have recently suffered a myocardial infarction.
If the patient has been diagnosed with an intolerance to some sugars, consult a doctor before taking this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may reduce the reaction rate, especially at the beginning of treatment, therefore, during treatment, patients should avoid potentially hazardous activities that require increased attention and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is contraindicated, because the alkaloid reserpine penetrates the placenta and into breast milk. If it is necessary to use the drug for the period of treatment, breastfeeding should be discontinued.
Method of administration and doses
The medicine is prescribed to adults orally after meals.
On the 1st day, the initial dose is usually 1 tablet at night, on the 2nd day - 1 tablet 2 times a day, on the 3rd day - 1 tablet 3 times a day, then bring the total dose to 4-6 tablets per day. After achieving a stable therapeutic effect (usually after 10-14 days), the dose of the drug is gradually reduced to 1-2 tablets per day. The course of treatment is 3-4 weeks, but in some cases, according to indications, the drug should be taken long-term in a maintenance dose (1 tablet per day).
Children
There are no data on the use of the drug in children.
Overdose
Symptoms: sweating, general weakness and severe hypotension. In severe cases, after a short period of euphoria, drowsiness, hypodynamia, severe depression (which can lead to suicide), severe parkinsonism, loss of consciousness, coma, convulsions, respiratory depression, hypothermia develop.
Treatment: gastric lavage, administration of activated charcoal. Forced diuresis is indicated. With a pronounced decrease in blood pressure, in case of collapse, lay the patient down and raise his legs; if necessary, intravenous administration of rheopoliglyukin or mezaton with the addition of angiotensinamide or 2% solution of noradrenaline hydrotartrate is indicated. Adrenomimetic agents should be prescribed with great caution due to the risk of developing pulmonary edema. Subcutaneously administer 10% solution of caffeine-sodium benzoate. The presence of sharp respiratory depression or its delay requires suctioning mucus from the respiratory tract, intubation and artificial ventilation of the lungs, oxygen therapy.
There are no specific antidotes for poisoning with raunatin and other rauwolfia preparations.
Adverse reactions
The drug is usually well tolerated. Sometimes there may be:
Cardiovascular system: edema, hot flashes, bradycardia, in patients with angina pectoris, increased pain in the heart area is possible; with prolonged use, an increase in the frequency of angina attacks is possible.
From the nervous system: headache, drowsiness, sweating, depression, general weakness; with prolonged use - the appearance of nightmares, the development of symptoms of parkinsonism.
From the organs of vision: miosis.
On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, increased or decreased appetite, drooling, dry mouth, increased secretion of gastric juice.
On the part of the hepatobiliary system: with prolonged use in high doses, liver function disorders are possible.
From the genitourinary system: dysuria, impotence.
On the part of the endocrine system and metabolism: decreased libido, sodium retention, increased prolactin secretion, galactorrhea, gynecomastia, swelling of the mammary glands, weight gain.
Allergic reactions: skin rashes, itching, dryness of the mucous membranes, swelling of the nasal mucosa.
From the hematopoietic system: thrombocytopenic purpura.
Side effects resolve when the dose is reduced or after a short (1-3 days) break in taking the drug.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
