The instruction for medical use
of RAUNATINUM-HEALTH medicine
the Trade name
of Raunatin-Zdorovye
the International unlicensed name
Is not present
the Dosage form
of the Tablet,
Structure
One tablet contains coated, 2 mg:
Active agent - Raunatinum in terms of 100% content of alkaloids is 2 mg,
excipients: sugar, potato starch or starch corn, glucose, calcium stearate, stearic acid, liquid paraffin,
structure of a cover: sugar, magnesium a carbonate easy, the titan dioxide (E 171), povidone, dye sikovit Green Z 2755, talc, silicon dioxide colloidal, beeswax, liquid paraffin.
The description
of the Tablet, coated, light green color, with a biconvex surface. On a surface of tablets the marbling and impregnations is allowed. On cross section three layers are visible.
Pharmacotherapeutic group
Hypotensive drugs. Rauwolfias alkaloids of Rauwolfia of alkaloids sum.
The ATX C02AA04 code
the Pharmacological
Rauwolfia Pharmacokinetics properties alkaloids are well soaked up from digestive tract. The maximum concentration in blood is observed in 1–3 hours after reception. Linking with blood proteins makes 40–50%. Elimination half-life – 50–170 hours. Are metabolized in intestines and a liver, are removed, mainly, with a stake and also with urine.
The pharmacodynamics
Drug contains the sum of alkaloids from roots of Rauwolfia snake (Rauwolfia serpentina Benth.) or bark of roots of Rauwolfia of emetic (Rauwolfia vomitoria Afz) of family of kurtovy (Apocynaceae). Alkaloids are provided by reserpine, serpentine, Ajmalinum, etc. The general content of alkaloids – not less than 90%.
Raunatinum has the hypotensive effect caused by decrease in content of biogenous monoamines (noradrenaline, dopamine, serotonin) in the central nervous system (kortiko-hypothalamic structures, especially back part of a hypothalamus). Breaking processes of deposition of a mediator in vesicles of a presynaptic membrane of peripheral adrenergic nerve terminations, a vascular wall, a medulla of adrenal glands, drug blocks adrenergic transfer that leads to a gradual lowering of arterial pressure. The hypotensive effect of drug develops more gradually, than at reserpine, but on expressiveness significantly does not concede to reserpine. Feature of drug is strengthening of glomerular filtration in kidneys that leads to increase in renal blood circulation.
Drug has also antiarrhytmic action and the calming influence on the central nervous system. Sedative effect of drug is significant to a lesser extent, than at reserpine.
The therapeutic effect of drug develops gradually by 10–14 day after the beginning of its use and remains for 2–3 months.
In some cases Raunatinum is transferred better than reserpine.
Indications
- arterial hypertension of easy and average degree
Appoint the Route of administration and doses the adult inside after a meal.
In the 1st day the initial dose usually makes 1 tablet for the night, for the 2nd day – on 1 tablet 2 times a day, for the 3rd day – on 1 tablet 3 times a day, then bring the general dose to 4–6 tablets a day. The maximum single dose – 2 tablets, the maximum daily dose – 6 tablets.
After achievement of steady therapeutic effect (as a rule, in 10–14 days) the drug dose is gradually reduced to 1–2 tablets a day. A course of treatment – 3–4 weeks, but in some cases according to indications the drug is taken it is long in a maintenance dose (1 tablet a day).
Single and daily doses and also duration of treatment is established individually by the doctor.
Side effects
Seldom
- nausea, vomiting, diarrhea, an abdominal pain, increase or a loss of appetite
- a headache perspiration, the general weakness, drowsiness, a depression
- bradycardia
- allergic reactions (skin rashes, an itching, dryness of mucous membranes, a rhinedema)
- a miosis
- a dysuria, a sodium delay
- impotence, decrease in a libido, increase in secretion of prolactin, a galactorrhoea, a gynecomastia, a nagrubaniye of mammary glands, increase in body weight
- a Werlhof's disease
Are possible at prolonged use
- strengthening of pains in heart (at patients with stenocardia)
- increase of attacks of stenocardia
- hypostases, rushes of blood to the person
- an abnormal liver function
- emergence of dreadful dreams
-
Usually by-effects undergo development of symptoms of parkinsonism at reduction of a dose or after short-term (1-3 days) a break in administration of drug.
Contraindications
- the increased individual sensitivity to alkaloids of Rauwolfia or other components of drug
- arterial hypotension
- heart failure, organic lesions of heart, bradycardia, aortal defects
- the profound cerebral atherosclerosis
- a depression
- epilepsy, parkinsonism
- a peptic ulcer of a stomach and duodenum in an aggravation stage
- nephrosclerosis
- bronchial asthma
- the period of pregnancy and a lactation
- a pheochromocytoma
Medicinal interactions
Antihypertensive effect of Raunatinum amplifies at use with other antihypertensive drugs (thiazide diuretics, b-adrenoblockers, inhibitors of antiotenzinprevrashchayushchy enzyme, antagonists of calcium ions, etc.). Strengthens the oppressing action on the central nervous system of alcohol, barbiturates, antidepressants, at simultaneous use with inhibitors of a monoaminooxidase the excitement and hypertensia can develop. Reduces efficiency of protivoparkinsonichesky means and sympathomimetics. Drugs of a digitalis and quinidine at simultaneous use with Raunatinum can cause arrhythmia.
The special
instructions Drug treatment it has to be carried out under observation of the doctor. At patients with stenocardia strengthening of pain in heart is possible. As alkaloids of Rauwolfia increase motility and secretion in a digestive tract, it is necessary to be careful at drug use by patients with anamnestic data on a peptic ulcer. Also should observe extra care when prescribing drug the weakened patients and patients of advanced age, in the presence of a renal failure, cholelithiasis, arrhythmia and to the patients who recently had a myocardial infarction.
Before planned surgeries the administration of drug should be stopped some days before operation. In case of need premedication atropine is necessary for immediate surgery under the general anesthesia at the patients accepting Raunatinum. It is not necessary to use drug before a countershock session.
Use in pediatrics
the Data on use of drug for children are absent.
Pregnancy and the period of a lactation
Use of drug during pregnancy and feeding by a breast contraindicated as alkaloid reserpine gets through a placenta and into breast milk. In need of use of drug during a lactation the feeding by a breast should be stopped.
Influence on a possibility of control of vehicles and mechanisms
Drug can break ability of the patient to fast reactions, especially in an initiation of treatment owing to what during a course of treatment drug patients should avoid potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.
Overdose
Symptoms: perspiration, general weakness and profound hypotension. In hard cases after the short period of euphoria the drowsiness, a depression, a hypodynamia, the phenomena of the profound parkinsonism, spasms, respiratory depression, a hypothermia, a loss of consciousness, a coma develops.
Treatment: drug withdrawal, gastric lavage, intake of activated carbon. The artificial diuresis is shown. In the profound lowering of arterial pressure, at collapse of the patient it is necessary to lay with the raised legs. If necessary intravenous administration of a reopoliglyukin or phenylephine hydrochloride with addition of Angiotensinamidum or 2% of solution of noradrenaline of hydrotartrate is shown. Adrenomimetichesky means are appointed carefully because of risk of developing a fluid lungs. Subcutaneously enter 10% solution caffeine-sodium benzoate. Presence of sharp respiratory depression or its delay demand suction of slime from airways, an intubation and carrying out artificial ventilation of the lungs, oxygenotherapy.
There are no specific antidotes in poisoning with Raunatinum and other drugs of Rauwolfia.
The form of release and packing
On 10 or 20 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 5 blister strip packagings on 10 tablets or 1 blister strip packaging on 20 tablets together with the instruction for medical use in the state and Russian languages place in a box of cardboard import.
On 500 blister strip packagings on 10 tablets or on 300 blister strip packagings on 20 tablets together with the corresponding number of instructions for medical use in the state and Russian languages in a box from corrugated fibreboard.
To Store storage conditions in the place protected from light, at a temperature not over 25 of 0C.
To store out of children's reach!
3 years
not to use a period of storage after the expiry date specified on packing!
Prescription status
According to the prescription
LLC Pharmaceutical Company Zdorovye Producer.
Ukraine, 61013, Kharkiv, Shevchenko St., 22.
ph. (057) 757-0-777
fax (057) 714-96-20
The owner of the registration certificate
of LLC Pharmaceutical Company Zdorovye, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) the Address: Limited liability partnership of Pharmaceutical Euro, 050039, Almaty, Mailing St., 72, apartment 34 Phone number: +7 (272) 71-10-17Факс: +7(272) 71-84-97Эл. address:
To Develop farmevro@mail.ru
of RAUNATINUM-HEALTH medicine
the Trade name
of Raunatin-Zdorovye
the International unlicensed name
Is not present
the Dosage form
of the Tablet,
Structure
One tablet contains coated, 2 mg:
Active agent - Raunatinum in terms of 100% content of alkaloids is 2 mg,
excipients: sugar, potato starch or starch corn, glucose, calcium stearate, stearic acid, liquid paraffin,
structure of a cover: sugar, magnesium a carbonate easy, the titan dioxide (E 171), povidone, dye sikovit Green Z 2755, talc, silicon dioxide colloidal, beeswax, liquid paraffin.
The description
of the Tablet, coated, light green color, with a biconvex surface. On a surface of tablets the marbling and impregnations is allowed. On cross section three layers are visible.
Pharmacotherapeutic group
Hypotensive drugs. Rauwolfias alkaloids of Rauwolfia of alkaloids sum.
The ATX C02AA04 code
the Pharmacological
Rauwolfia Pharmacokinetics properties alkaloids are well soaked up from digestive tract. The maximum concentration in blood is observed in 1–3 hours after reception. Linking with blood proteins makes 40–50%. Elimination half-life – 50–170 hours. Are metabolized in intestines and a liver, are removed, mainly, with a stake and also with urine.
The pharmacodynamics
Drug contains the sum of alkaloids from roots of Rauwolfia snake (Rauwolfia serpentina Benth.) or bark of roots of Rauwolfia of emetic (Rauwolfia vomitoria Afz) of family of kurtovy (Apocynaceae). Alkaloids are provided by reserpine, serpentine, Ajmalinum, etc. The general content of alkaloids – not less than 90%.
Raunatinum has the hypotensive effect caused by decrease in content of biogenous monoamines (noradrenaline, dopamine, serotonin) in the central nervous system (kortiko-hypothalamic structures, especially back part of a hypothalamus). Breaking processes of deposition of a mediator in vesicles of a presynaptic membrane of peripheral adrenergic nerve terminations, a vascular wall, a medulla of adrenal glands, drug blocks adrenergic transfer that leads to a gradual lowering of arterial pressure. The hypotensive effect of drug develops more gradually, than at reserpine, but on expressiveness significantly does not concede to reserpine. Feature of drug is strengthening of glomerular filtration in kidneys that leads to increase in renal blood circulation.
Drug has also antiarrhytmic action and the calming influence on the central nervous system. Sedative effect of drug is significant to a lesser extent, than at reserpine.
The therapeutic effect of drug develops gradually by 10–14 day after the beginning of its use and remains for 2–3 months.
In some cases Raunatinum is transferred better than reserpine.
Indications
- arterial hypertension of easy and average degree
Appoint the Route of administration and doses the adult inside after a meal.
In the 1st day the initial dose usually makes 1 tablet for the night, for the 2nd day – on 1 tablet 2 times a day, for the 3rd day – on 1 tablet 3 times a day, then bring the general dose to 4–6 tablets a day. The maximum single dose – 2 tablets, the maximum daily dose – 6 tablets.
After achievement of steady therapeutic effect (as a rule, in 10–14 days) the drug dose is gradually reduced to 1–2 tablets a day. A course of treatment – 3–4 weeks, but in some cases according to indications the drug is taken it is long in a maintenance dose (1 tablet a day).
Single and daily doses and also duration of treatment is established individually by the doctor.
Side effects
Seldom
- nausea, vomiting, diarrhea, an abdominal pain, increase or a loss of appetite
- a headache perspiration, the general weakness, drowsiness, a depression
- bradycardia
- allergic reactions (skin rashes, an itching, dryness of mucous membranes, a rhinedema)
- a miosis
- a dysuria, a sodium delay
- impotence, decrease in a libido, increase in secretion of prolactin, a galactorrhoea, a gynecomastia, a nagrubaniye of mammary glands, increase in body weight
- a Werlhof's disease
Are possible at prolonged use
- strengthening of pains in heart (at patients with stenocardia)
- increase of attacks of stenocardia
- hypostases, rushes of blood to the person
- an abnormal liver function
- emergence of dreadful dreams
-
Usually by-effects undergo development of symptoms of parkinsonism at reduction of a dose or after short-term (1-3 days) a break in administration of drug.
Contraindications
- the increased individual sensitivity to alkaloids of Rauwolfia or other components of drug
- arterial hypotension
- heart failure, organic lesions of heart, bradycardia, aortal defects
- the profound cerebral atherosclerosis
- a depression
- epilepsy, parkinsonism
- a peptic ulcer of a stomach and duodenum in an aggravation stage
- nephrosclerosis
- bronchial asthma
- the period of pregnancy and a lactation
- a pheochromocytoma
Medicinal interactions
Antihypertensive effect of Raunatinum amplifies at use with other antihypertensive drugs (thiazide diuretics, b-adrenoblockers, inhibitors of antiotenzinprevrashchayushchy enzyme, antagonists of calcium ions, etc.). Strengthens the oppressing action on the central nervous system of alcohol, barbiturates, antidepressants, at simultaneous use with inhibitors of a monoaminooxidase the excitement and hypertensia can develop. Reduces efficiency of protivoparkinsonichesky means and sympathomimetics. Drugs of a digitalis and quinidine at simultaneous use with Raunatinum can cause arrhythmia.
The special
instructions Drug treatment it has to be carried out under observation of the doctor. At patients with stenocardia strengthening of pain in heart is possible. As alkaloids of Rauwolfia increase motility and secretion in a digestive tract, it is necessary to be careful at drug use by patients with anamnestic data on a peptic ulcer. Also should observe extra care when prescribing drug the weakened patients and patients of advanced age, in the presence of a renal failure, cholelithiasis, arrhythmia and to the patients who recently had a myocardial infarction.
Before planned surgeries the administration of drug should be stopped some days before operation. In case of need premedication atropine is necessary for immediate surgery under the general anesthesia at the patients accepting Raunatinum. It is not necessary to use drug before a countershock session.
Use in pediatrics
the Data on use of drug for children are absent.
Pregnancy and the period of a lactation
Use of drug during pregnancy and feeding by a breast contraindicated as alkaloid reserpine gets through a placenta and into breast milk. In need of use of drug during a lactation the feeding by a breast should be stopped.
Influence on a possibility of control of vehicles and mechanisms
Drug can break ability of the patient to fast reactions, especially in an initiation of treatment owing to what during a course of treatment drug patients should avoid potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.
Overdose
Symptoms: perspiration, general weakness and profound hypotension. In hard cases after the short period of euphoria the drowsiness, a depression, a hypodynamia, the phenomena of the profound parkinsonism, spasms, respiratory depression, a hypothermia, a loss of consciousness, a coma develops.
Treatment: drug withdrawal, gastric lavage, intake of activated carbon. The artificial diuresis is shown. In the profound lowering of arterial pressure, at collapse of the patient it is necessary to lay with the raised legs. If necessary intravenous administration of a reopoliglyukin or phenylephine hydrochloride with addition of Angiotensinamidum or 2% of solution of noradrenaline of hydrotartrate is shown. Adrenomimetichesky means are appointed carefully because of risk of developing a fluid lungs. Subcutaneously enter 10% solution caffeine-sodium benzoate. Presence of sharp respiratory depression or its delay demand suction of slime from airways, an intubation and carrying out artificial ventilation of the lungs, oxygenotherapy.
There are no specific antidotes in poisoning with Raunatinum and other drugs of Rauwolfia.
The form of release and packing
On 10 or 20 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 5 blister strip packagings on 10 tablets or 1 blister strip packaging on 20 tablets together with the instruction for medical use in the state and Russian languages place in a box of cardboard import.
On 500 blister strip packagings on 10 tablets or on 300 blister strip packagings on 20 tablets together with the corresponding number of instructions for medical use in the state and Russian languages in a box from corrugated fibreboard.
To Store storage conditions in the place protected from light, at a temperature not over 25 of 0C.
To store out of children's reach!
3 years
not to use a period of storage after the expiry date specified on packing!
Prescription status
According to the prescription
LLC Pharmaceutical Company Zdorovye Producer.
Ukraine, 61013, Kharkiv, Shevchenko St., 22.
ph. (057) 757-0-777
fax (057) 714-96-20
The owner of the registration certificate
of LLC Pharmaceutical Company Zdorovye, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) the Address: Limited liability partnership of Pharmaceutical Euro, 050039, Almaty, Mailing St., 72, apartment 34 Phone number: +7 (272) 71-10-17Факс: +7(272) 71-84-97Эл. address:
To Develop farmevro@mail.ru
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