Nitrospray sublingual dose dosed 0.4 mg/dose 200 doses bottle 1 pc. in Yaroslavl
Latin name
NITROSPRAY
International nonproprietary name
nitroglycerin (glyceryl trinitrate) (nitroglycerin)
Release form
Sublingual dosed aerosol.
Package
10 ml (200 doses) - polypropylene bottles (1) with a mechanical dosing pump complete with a spray nozzle - cardboard packs.
Description
Sublingual spray dosed in the form of a clear, colorless liquid.
pharmachologic effect
Peripheral vasodilator with a predominant effect on venous vessels, antianginal drug. The effects of nitroglycerin are due to the ability to release nitric oxide from its molecule, which is a natural endothelial relaxing factor. Nitric oxide increases the intracellular concentration of cyclic guanosine monophosphatase, which prevents the penetration of calcium ions into smooth muscle cells and causes them to relax. Relaxation of the smooth muscles of the vascular wall causes vasodilation, which reduces venous return to the heart (preload) and resistance of the systemic circulation (afterload). This reduces the work of the heart and the myocardium's need for oxygen. Dilatation of coronary vessels improves coronary blood flow and promotes its redistribution to areas with reduced blood supply, which increases oxygen delivery to the myocardium. A decrease in venous return leads to a decrease in filling pressure, improved blood supply to the subendocardial layers, a decrease in pressure in the pulmonary circulation and regression of symptoms of pulmonary edema. Nitroglycerin has a central inhibitory effect on the sympathetic tone of blood vessels, inhibiting the vascular component of the formation of pain. Nitroglycerin also relaxes the smooth muscle cells of the bronchi, urinary tract, gallbladder, bile ducts, esophagus, small and large intestines, as well as their sphincters.
Indications
relief and prevention of angina attacks.
Directions for use and doses
Nitrospray-ICN is taken sublingually, in a sitting position, while holding your breath. Relief of an attack of angina: 1-2 doses containing 0.4-0.8 mg of nitroglycerin (if necessary, again after no less than 30 seconds), a maximum of 3 doses at intervals of 5 minutes. Prevention of angina attacks: 1 dose 5-10 minutes before expected exercise or stress. The maximum single dose is 1.6 mg (4 doses), daily dose is 6.4 mg (16 doses).
Compound
1 dose of nitroglycerin (in the form of a 4% solution) 400 mcg Excipients: ethanol (rectified ethyl alcohol).
Contraindications
- shock; - vascular collapse; - acute myocardial infarction with hypotension; — arterial hypotension (systolic blood pressure below 90 mm Hg); - hemorrhagic stroke; - recent head injury; - constrictive pericarditis; — closed-angle form of glaucoma; - hypertrophic cardiomyopathy; - toxic pulmonary edema; - pregnancy; - lactation period (breastfeeding); - childhood; - hypersensitivity to nitroglycerin and other organic nitrates.
special instructions
Due to the increased risk of developing orthostatic reactions during the period of use of the drug, caution should be exercised when abruptly moving to a standing position from a lying or sitting position, during prolonged standing, when performing physical exercises, or in hot weather. Discontinuation of the drug should be done gradually and under the supervision of a physician. During the period of use of the drug, you should avoid drinking alcohol.
Side effects
From the side of the central nervous system: blurred vision, headache (especially at the beginning of the course of treatment, with continued therapy it decreases), dizziness, weakness, restlessness. From the cardiovascular system: arterial hypotension (including orthostatic), reflex tachycardia, facial hyperemia; rarely (with a sharp decrease in blood pressure) – increased symptoms of angina pectoris (paradoxical “nitrate” reactions). From the digestive system: dry mouth, nausea, vomiting. Dermatological reactions: dermatitis, skin rash.
Drug interactions
Other antihypertensive drugs, antidepressants, PDE inhibitors (sildenafil), ethanol may enhance the hypotensive effect of Nitrospray. In this case, the effectiveness of Nitrospray may decrease. When used simultaneously with Nitrospray, the anticoagulant effect of heparin may be reduced.
Storage conditions
List B. The drug should be stored in a place protected from light and out of reach of children at temperatures up to 30°C, away from open flame.
Nitrospray sublingual dose. 0.4 mg/dose 200 doses 10 ml
Registration Certificate Holder
PHARMSTANDARD-LEKSREDSTVA (Russia)
Dosage form
Medicine - Nitrospray
Description
Sublingual dosed spray
in the form of a clear, colorless liquid.
1 dose
nitroglycerin (as a 4% solution) 400 mcg
Excipients
: ethanol (rectified ethyl alcohol).
10 ml (200 doses) - polypropylene bottles (1) with a mechanical dosing pump complete with a spray nozzle - cardboard packs.
Indications
- relief and prevention of angina attacks.
Contraindications for use
- shock;
- vascular collapse;
- acute myocardial infarction with hypotension;
- arterial hypotension (systolic blood pressure below 90 mmHg);
- hemorrhagic stroke;
- recent head injury;
- constrictive pericarditis;
- closed-angle form of glaucoma;
- hypertrophic cardiomyopathy;
- toxic pulmonary edema;
- pregnancy;
- lactation period (breastfeeding);
- childhood;
- hypersensitivity to nitroglycerin and other organic nitrates.
pharmachologic effect
Peripheral vasodilator with a predominant effect on venous vessels, antianginal drug.
The effects of nitroglycerin are due to the ability to release nitric oxide from its molecule, which is a natural endothelial relaxing factor. Nitric oxide increases the intracellular concentration of cyclic guanosine monophosphatase, which prevents the penetration of calcium ions into smooth muscle cells and causes them to relax. Relaxation of the smooth muscles of the vascular wall causes vasodilation, which reduces venous return to the heart (preload) and resistance of the systemic circulation (afterload). This reduces the work of the heart and the myocardium's need for oxygen. Dilatation of coronary vessels improves coronary blood flow and promotes its redistribution to areas with reduced blood supply, which increases oxygen delivery to the myocardium. A decrease in venous return leads to a decrease in filling pressure, improved blood supply to the subendocardial layers, a decrease in pressure in the pulmonary circulation and regression of symptoms of pulmonary edema. Nitroglycerin has a central inhibitory effect on the sympathetic tone of blood vessels, inhibiting the vascular component of the formation of pain. Nitroglycerin also relaxes the smooth muscle cells of the bronchi, urinary tract, gallbladder, bile ducts, esophagus, small and large intestines, as well as their sphincters.
Drug interactions
Other antihypertensive drugs, antidepressants, PDE inhibitors (sildenafil), ethanol may enhance the hypotensive effect of Nitrospray. In this case, the effectiveness of Nitrospray may decrease.
When used simultaneously with Nitrospray, the anticoagulant effect of heparin may be reduced.
Dosage regimen
The drug is used sublingually. Each press of the dosing pump releases 1 dose (400 mcg of nitroglycerin) as an aerosol.
To relieve an attack of angina
at the first signs of it, 400-800 mcg (1-2 doses) are applied to or under the tongue while holding your breath. The interval between repeated doses should be at least 30 seconds. If necessary, the drug is re-administered at 5-minute intervals, but not more than 3 doses within 15 minutes.
To prevent the development of an attack
administer 400 mcg (1 dose) 5-10 minutes before the expected load or stress.
The maximum single dose is 1.6 g (4 doses), the maximum daily dose is 6.4 g (16 doses).
Before first use or after a long break in use, it is recommended to fill the aerosol chamber by pressing the dispensing valve several times until the aerosol appears. The packaging should not be shaken before use; when spraying, it should be held vertically, directly in front of you. After each spray of the aerosol, you should close your mouth; it is recommended not to swallow immediately.
Overdose
Symptoms:
cyanosis of the lips, nails, palms, dizziness, fainting, feeling of strong pressure in the head, shortness of breath, unusual fatigue or weakness, weak and rapid heartbeat, elevated body temperature, convulsions.
Treatment:
transferring the patient to a lying position with elevated legs, conducting symptomatic and supportive therapy.
Side effect
From the side of the central nervous system:
blurred vision, headache (especially at the beginning of treatment, decreases with continued therapy), dizziness, weakness, restlessness.
From the cardiovascular system:
arterial hypotension (including orthostatic), reflex tachycardia, facial hyperemia;
rarely (with a sharp decrease in blood pressure) – increased symptoms of angina pectoris (paradoxical “nitrate” reactions). From the digestive system:
dry mouth, nausea, vomiting.
Dermatological reactions:
dermatitis, skin rash.
special instructions
Due to the increased risk of developing orthostatic reactions during the period of use of the drug, caution should be exercised when abruptly moving to a standing position from a lying or sitting position, during prolonged standing, when performing physical exercises, or in hot weather.
Discontinuation of the drug should be done gradually and under the supervision of a physician.
During the period of use of the drug, you should avoid drinking alcohol.
Storage conditions
List B. The drug should be stored in a place protected from light and out of reach of children at temperatures up to 30°C, away from open flame.
Best before date
Shelf life – 3 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
The drug is contraindicated for use during pregnancy and lactation.
Use in children
Restrictions for children - Contraindicated.
Contraindicated: children's age.
Terms of sale
The drug is approved for use as a means of OTC.
Contacts for inquiries
PHARMSTANDARD JSC (Russia)
141701 Moscow region. Dolgoprudny, Likhachevsky pr-d, 5B Tel./fax E-mail
Nitrospray
Nitrospray (active ingredient - nitroglycerin) is a peripheral vasodilator drug of the nitrate group, which has an antianginal (anti-ischemic) effect and is used to relieve and prevent angina symptoms. Affects mainly venous vessels. Nitrates are rightfully considered one of the most effective groups of antianginal drugs, which have extensive experience in using both for the prevention of angina attacks and for their relief. Recently, nitroglycerin preparations in aerosol form have become increasingly popular. One of these drugs is the domestic drug nitrospray. The high effectiveness of aerosols is due to the rapid onset of the therapeutic effect precisely at those moments when the speed of action is the most important pharmacological characteristic - when relieving angina attacks. The effects of nitrospray (as well as other nitroglycerin preparations) are due to the ability of the active substance to split off a molecule of nitric oxide, known as endogenous endothelium-relaxing factor. Nitric oxide increases the level of cyclic guanosine monophosphatase inside cells, which prevents the penetration of calcium ions into the smooth muscle cells of the vascular wall, causing them to relax. The result of relaxation of the smooth muscle “cocoon” of blood vessels is vasodilation, a decrease in preload (due to a decrease in venous return) and afterload (due to a decrease in the resistance of the systemic vessels) on the myocardium. Thus, the heart is largely unloaded and reduces its demand for oxygen consumption. Increasing the lumen of the coronary vessels normalizes coronary circulation and redistributes blood flow in favor of ischemic areas of the myocardium. The reduction in venous return already mentioned above entails a decrease in filling pressure in the cavities of the heart, improved blood circulation in the subendocardial layers of the myocardium, a decrease in pressure in the pulmonary circulation and the elimination of pulmonary edema.
Nitrospray has a direct inhibitory effect on sympathetic vascular tone, suppressing the vascular component of the formation of pain. In addition to this, the drug exhibits a relaxing effect on smooth muscle cells of the respiratory, digestive (including sphincters of the esophagus, small and large intestines) and urogenital tract, bile ducts and gallbladder. Nitrospray is quickly and completely absorbed from the surface of the mucous membranes at the site of application. The concentration of the active substance sufficient to realize the therapeutic effect is achieved in a few minutes. The half-life of nitroglycerin when taken orally is 4 hours, however, since nitrospray is produced in the form of an aerosol for sublingual (sublingual) use, this figure will be significantly lower - no more than 20 minutes. The manufacturer placed the drug in a can with a metering pump, each press of which releases 1 dose equivalent to 400 mcg of nitroglycerin. To relieve an angina attack at its first manifestations, it is recommended to take 1-2 doses of nitrospray on or under the tongue, holding your breath first. The interval between repeated injections should be at least 30 seconds. If necessary, several injections can be made at five-minute intervals, but not more than 1200 mcg within 15 minutes. For preventive purposes, nitrospray in the amount of 1 dose is administered 5-10 minutes before the expected physical activity or psycho-emotional stress. The maximum amount of the drug administered at a time should not exceed 1600 mcg. The maximum daily dose of nitrospey is 6400 mcg. Due to the increased risk of postural hypotension during the use of nitrospray, caution must be exercised when changing the position of the body in space. Discontinuation of the drug should not be abrupt due to the risk of rebound syndrome. Nitrospray is incompatible with alcohol.
