Nitroglycerin-KZ 0.5 mg sublingual (40 tablets)
- $4.20
The instruction
for medical use
of NITROGLITSERIN-KZ medicine
the Trade name
of Nitroglitserin-KZ
the International unlicensed name
Is not present
the Dosage form
of the Tablet hypoglossal, 0.5 mg.
Structure
One tablet contains
active agent: nitroglycerine of 2% on lactose, in terms of nitroglycerine of 0.5 mg,
excipients: lactoses monohydrate, povidone 25, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate.
The description
Single-layer tablets of round shape, with flat upper and lower surfaces which edges are slanted, with a stroke, white or almost white color. On a surface of tablets the marbling is allowed.
On a break under a magnifying glass it is visible rather uniform structure.
Pharmacotherapeutic group
of Vazodilatatora, for treatment of heart diseases. Organic nitrates. Nitroglycerine.
ATX C01D A02 code.
Pharmacological
Pharmacokinetics properties.
It is quickly and completely absorbed from the surface of mucous membranes. At sublingual use at once gets to a system blood stream, bioavailability – 100%, the maximum concentration in blood plasma is noted in 5 min. Communication with blood proteins makes 60%.
Pharmacodynamics. A peripheral vazodilatator with primary influence on venous vessels. Effect of nitroglycerine is connected mainly with reduction of need of a myocardium for oxygen due to reduction of preloading (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (reduction of the general peripheric vascular resistance).
Has the central braking impact on a sympathetic tone of vessels, oppressing a vascular component of forming of a pain syndrome. Causes expansion of meningeal vessels, than the headache at its use speaks.
At use of sublingual forms the stenocardia attack usually is eliminated in 1.5 minutes, the hemodynamic and anti-anginal effect remains from 30 to 60 min.
Indications
- stopping of attacks of stenocardia and prevention of attacks
Apply the Route of administration and doses the adult.
Appointing drug for the first time, it is necessary to investigate its influence on the level of arterial blood pressure. Control of efficiency of use of Nitroglycerine needs to be exercised on the heart rate and level of arterial blood pressure.
It is necessary to accept at once at the first symptoms of an attack of stenocardia.
At once when developing pain at stenocardia attacks to put one tablet under language and to hold in a mouth before full resorption, without swallowing. A usual dose of drug – 1 tablet under language. In the absence of anti-anginal action within 3-5 minutes it is necessary to take 1 more Tabulettae Nitroglycerini. Maximum dose of 6 tablets.
In the absence of therapeutic effect after reception of 2-3 tablets it is necessary to call the doctor.
At frequent attacks of stenocardia it is reasonable to use drugs of the prolonged action.
Side effects
from central nervous system: illegibility of sight, headache, dizziness and feeling of weakness, uneasiness, psychotic reactions, block, disorientation.
From a cardiovascular system: reflex tachycardia, hyperaemia of integuments, feeling of heat, arterial hypotension, including orthostatic collapse, cyanosis, cyanosis, pallor, methemoglobinemia.
From digestive system: nausea, vomiting, dryness in a mouth, an abdominal pain, diarrhea are possible.
From the immune system: allergic reactions, including skin rash, itching, acute anaphylaxis.
Others: excitability, disorders of vision, exacerbation of glaucoma, hypothermia. At sudden falling of arterial blood pressure
strengthening of symptoms of stenocardia (paradoxical nitrate reactions) can sometimes be observed.
Contraindications
- hypersensitivity to nitrates
- shock, collapse, arterial hypotension (systolic arterial blood pressure is lower than 100 mm Hg., diastolic arterial blood pressure is lower than 60 mm Hg.)
- an acute myocardial infarction with the low filling pressure of a left ventricle
- a hypertrophic subaortic stenosis
- increase in intracranial pressure (including in a hemorrhagic stroke, after recently suffered head injury)
- closed-angle glaucoma with high intraocular pressure
- simultaneous use with sildenafily and other inhibitors of phosphodiesterase
- bradycardia (less than 50 ud. / mines)
- cerebral ischemia
- a cardiac tamponade
- primary pulmonary hypertensia
- a toxic fluid lungs
- pregnancy and the period of a lactation
- an aortal stenosis
- children's and teenage age up to 18 years.
Medicinal interactions
At simultaneous use with other vazodilatator, antihypertensives, APF inhibitors, blockers of slow calcium channels, phosphodiesterase inhibitors, diuretics, tricyclic antidepressants, MAO inhibitors, ethanol and etanolsoderzhashchy drugs, beta blockers, procaineamides, quinidine, novokainamidy, hypotensive effect of nitroglycerine amplifies.
The atropine and other drugs having M-cholinolytic effect can reduce effect of nitroglycerine owing to decrease in secretion and bioavailability of drug.
Use with dihydroergotamine can lead to increase in its concentration in blood plasma and to increase in arterial blood pressure (owing to increase in bioavailability of dihydroergotamine).
At simultaneous use with heparin the decrease in anticoagulating action of the last is possible (after drug withdrawal perhaps considerable decrease in blood clotting that the heparin dose decline can demand).
Phenobarbital activates metabolism of nitrates in a liver. Alpha adrenomimetiki, the histamine, Pituitrinum, corticosteroids, central nervous system stimulators, poison of bees, snakes, sunshine reduce anti-anginal effect of nitroglycerine. Salicylates increase nitroglycerine level in blood, barbiturates accelerate his metabolism. Donators of sulfhydryl groups (captopril, Acetylcysteinum, Unithiolum) restore reduced sensitivity to nitroglycerine.
Special instructions
It is necessary with care, considering risk and advantage, to take the drug at: an uncontrolled hypovolemia, patients with heart failure with a normal or low pulmonary pressure, heavy anemia, a hyperthyroidism, disturbance of cerebral circulation, a heavy renal and/or liver failure (risk of developing a methemoglobinemia).
With care to apply in an aortal stenosis, a toxic fluid lungs and to patients with the profound cerebral atherosclerosis, to patients of advanced age. During treatment not to take alcohol. During treatment the visit of a bath, sauna, a hot shower is contraindicated.
The tablet cannot be chewed as through a mucous membrane of an oral cavity the excess amount of active ingredient can come to a system blood stream.
To nitroglycerine, as well as to other organic nitrates, at frequent use the accustoming (tolerance) which demands increase in dosing can develop. At prolonged use of Nitroglycerine for prevention of emergence of tolerance the administration of drug with breaks within a day (with an interval of 10-12 hours) or co-administration of antagonists of calcium, APF inhibitors or diuretics is recommended. If necessary at development of tolerance it is necessary to cancel temporarily Nitroglycerine use (for several days) and to replace it with anti-anginal means of other pharmacotherapeutic groups.
Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is not necessary to use drug.
Use during pregnancy or feeding by a breast
Use of nitroglycerine during pregnancy or feeding by a breast contraindicated.
Children
of Experience of use of drug to children are not present therefore its use is not recommended by this age category of patients.
The feature of influence of medicine on ability of control of motor transport or potentially dangerous mechanisms
At control of the vehicles and mechanisms requiring special attention should remember that intake of nitroglycerine can lead to reduction in the rate of reaction.
Overdose
Symptoms: a lowering of arterial pressure (it is lower than 90 mm Hg.) with orthostatic dysregulation, a headache, severe dizziness, a syncope, a cardiopalmus, nausea and vomiting, short wind, the significant weakness, the increased body temperature, arterial hypotension, feeling of heat or a fever, the increased sweating.
At use of high doses (more than 20 mkg/kg) – collapse, cyanosis of lips, nails or palms, a methemoglobinemia, dispnoe and a tachypnea.
Treatment: to turn the patient to horizontal position, to raise legs, in hard cases appoint plasma substitutes, sympathomimetics, oxygen, in a methemoglobinemia – methylene blue. Symptomatic therapy.
Form of release and packing
of the Tablet hypoglossal 0.5 mg.
On 40 tablets in a container polymeric.
Each container together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions in original packing at a temperature not over 25 of 0C.
To store out of children's reach!
Period of storage
2 years.
Not to use after the expiration date specified on packing.
Prescription status
Without prescription.
Producer
Private joint-stock company Technolog.
20300, Ukraine, city of Uman of the Cherkassk region, Manuilsky Street, 8.
Name and country of the owner of the registration certificate
Private joint-stock company Technolog.
20300, Ukraine, city of Uman of the Cherkassk region, Manuilsky Street, 8.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Stofarm LLP
111107, RK, Kostanay region
Kostanay district, item Zatobolsk
October 40 let St., 74
ph. 00 73 142 280170, 00 73 142 280186
e-mail:
To Develop vvnikushkin@stopharm.kz
for medical use
of NITROGLITSERIN-KZ medicine
the Trade name
of Nitroglitserin-KZ
the International unlicensed name
Is not present
the Dosage form
of the Tablet hypoglossal, 0.5 mg.
Structure
One tablet contains
active agent: nitroglycerine of 2% on lactose, in terms of nitroglycerine of 0.5 mg,
excipients: lactoses monohydrate, povidone 25, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate.
The description
Single-layer tablets of round shape, with flat upper and lower surfaces which edges are slanted, with a stroke, white or almost white color. On a surface of tablets the marbling is allowed.
On a break under a magnifying glass it is visible rather uniform structure.
Pharmacotherapeutic group
of Vazodilatatora, for treatment of heart diseases. Organic nitrates. Nitroglycerine.
ATX C01D A02 code.
Pharmacological
Pharmacokinetics properties.
It is quickly and completely absorbed from the surface of mucous membranes. At sublingual use at once gets to a system blood stream, bioavailability – 100%, the maximum concentration in blood plasma is noted in 5 min. Communication with blood proteins makes 60%.
Pharmacodynamics. A peripheral vazodilatator with primary influence on venous vessels. Effect of nitroglycerine is connected mainly with reduction of need of a myocardium for oxygen due to reduction of preloading (expansion of peripheral veins and reduction of inflow of blood to the right auricle) and afterloads (reduction of the general peripheric vascular resistance).
Has the central braking impact on a sympathetic tone of vessels, oppressing a vascular component of forming of a pain syndrome. Causes expansion of meningeal vessels, than the headache at its use speaks.
At use of sublingual forms the stenocardia attack usually is eliminated in 1.5 minutes, the hemodynamic and anti-anginal effect remains from 30 to 60 min.
Indications
- stopping of attacks of stenocardia and prevention of attacks
Apply the Route of administration and doses the adult.
Appointing drug for the first time, it is necessary to investigate its influence on the level of arterial blood pressure. Control of efficiency of use of Nitroglycerine needs to be exercised on the heart rate and level of arterial blood pressure.
It is necessary to accept at once at the first symptoms of an attack of stenocardia.
At once when developing pain at stenocardia attacks to put one tablet under language and to hold in a mouth before full resorption, without swallowing. A usual dose of drug – 1 tablet under language. In the absence of anti-anginal action within 3-5 minutes it is necessary to take 1 more Tabulettae Nitroglycerini. Maximum dose of 6 tablets.
In the absence of therapeutic effect after reception of 2-3 tablets it is necessary to call the doctor.
At frequent attacks of stenocardia it is reasonable to use drugs of the prolonged action.
Side effects
from central nervous system: illegibility of sight, headache, dizziness and feeling of weakness, uneasiness, psychotic reactions, block, disorientation.
From a cardiovascular system: reflex tachycardia, hyperaemia of integuments, feeling of heat, arterial hypotension, including orthostatic collapse, cyanosis, cyanosis, pallor, methemoglobinemia.
From digestive system: nausea, vomiting, dryness in a mouth, an abdominal pain, diarrhea are possible.
From the immune system: allergic reactions, including skin rash, itching, acute anaphylaxis.
Others: excitability, disorders of vision, exacerbation of glaucoma, hypothermia. At sudden falling of arterial blood pressure
strengthening of symptoms of stenocardia (paradoxical nitrate reactions) can sometimes be observed.
Contraindications
- hypersensitivity to nitrates
- shock, collapse, arterial hypotension (systolic arterial blood pressure is lower than 100 mm Hg., diastolic arterial blood pressure is lower than 60 mm Hg.)
- an acute myocardial infarction with the low filling pressure of a left ventricle
- a hypertrophic subaortic stenosis
- increase in intracranial pressure (including in a hemorrhagic stroke, after recently suffered head injury)
- closed-angle glaucoma with high intraocular pressure
- simultaneous use with sildenafily and other inhibitors of phosphodiesterase
- bradycardia (less than 50 ud. / mines)
- cerebral ischemia
- a cardiac tamponade
- primary pulmonary hypertensia
- a toxic fluid lungs
- pregnancy and the period of a lactation
- an aortal stenosis
- children's and teenage age up to 18 years.
Medicinal interactions
At simultaneous use with other vazodilatator, antihypertensives, APF inhibitors, blockers of slow calcium channels, phosphodiesterase inhibitors, diuretics, tricyclic antidepressants, MAO inhibitors, ethanol and etanolsoderzhashchy drugs, beta blockers, procaineamides, quinidine, novokainamidy, hypotensive effect of nitroglycerine amplifies.
The atropine and other drugs having M-cholinolytic effect can reduce effect of nitroglycerine owing to decrease in secretion and bioavailability of drug.
Use with dihydroergotamine can lead to increase in its concentration in blood plasma and to increase in arterial blood pressure (owing to increase in bioavailability of dihydroergotamine).
At simultaneous use with heparin the decrease in anticoagulating action of the last is possible (after drug withdrawal perhaps considerable decrease in blood clotting that the heparin dose decline can demand).
Phenobarbital activates metabolism of nitrates in a liver. Alpha adrenomimetiki, the histamine, Pituitrinum, corticosteroids, central nervous system stimulators, poison of bees, snakes, sunshine reduce anti-anginal effect of nitroglycerine. Salicylates increase nitroglycerine level in blood, barbiturates accelerate his metabolism. Donators of sulfhydryl groups (captopril, Acetylcysteinum, Unithiolum) restore reduced sensitivity to nitroglycerine.
Special instructions
It is necessary with care, considering risk and advantage, to take the drug at: an uncontrolled hypovolemia, patients with heart failure with a normal or low pulmonary pressure, heavy anemia, a hyperthyroidism, disturbance of cerebral circulation, a heavy renal and/or liver failure (risk of developing a methemoglobinemia).
With care to apply in an aortal stenosis, a toxic fluid lungs and to patients with the profound cerebral atherosclerosis, to patients of advanced age. During treatment not to take alcohol. During treatment the visit of a bath, sauna, a hot shower is contraindicated.
The tablet cannot be chewed as through a mucous membrane of an oral cavity the excess amount of active ingredient can come to a system blood stream.
To nitroglycerine, as well as to other organic nitrates, at frequent use the accustoming (tolerance) which demands increase in dosing can develop. At prolonged use of Nitroglycerine for prevention of emergence of tolerance the administration of drug with breaks within a day (with an interval of 10-12 hours) or co-administration of antagonists of calcium, APF inhibitors or diuretics is recommended. If necessary at development of tolerance it is necessary to cancel temporarily Nitroglycerine use (for several days) and to replace it with anti-anginal means of other pharmacotherapeutic groups.
Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is not necessary to use drug.
Use during pregnancy or feeding by a breast
Use of nitroglycerine during pregnancy or feeding by a breast contraindicated.
Children
of Experience of use of drug to children are not present therefore its use is not recommended by this age category of patients.
The feature of influence of medicine on ability of control of motor transport or potentially dangerous mechanisms
At control of the vehicles and mechanisms requiring special attention should remember that intake of nitroglycerine can lead to reduction in the rate of reaction.
Overdose
Symptoms: a lowering of arterial pressure (it is lower than 90 mm Hg.) with orthostatic dysregulation, a headache, severe dizziness, a syncope, a cardiopalmus, nausea and vomiting, short wind, the significant weakness, the increased body temperature, arterial hypotension, feeling of heat or a fever, the increased sweating.
At use of high doses (more than 20 mkg/kg) – collapse, cyanosis of lips, nails or palms, a methemoglobinemia, dispnoe and a tachypnea.
Treatment: to turn the patient to horizontal position, to raise legs, in hard cases appoint plasma substitutes, sympathomimetics, oxygen, in a methemoglobinemia – methylene blue. Symptomatic therapy.
Form of release and packing
of the Tablet hypoglossal 0.5 mg.
On 40 tablets in a container polymeric.
Each container together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions in original packing at a temperature not over 25 of 0C.
To store out of children's reach!
Period of storage
2 years.
Not to use after the expiration date specified on packing.
Prescription status
Without prescription.
Producer
Private joint-stock company Technolog.
20300, Ukraine, city of Uman of the Cherkassk region, Manuilsky Street, 8.
Name and country of the owner of the registration certificate
Private joint-stock company Technolog.
20300, Ukraine, city of Uman of the Cherkassk region, Manuilsky Street, 8.
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Stofarm LLP
111107, RK, Kostanay region
Kostanay district, item Zatobolsk
October 40 let St., 74
ph. 00 73 142 280170, 00 73 142 280186
e-mail:
To Develop vvnikushkin@stopharm.kz
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