Nitrosprey sublingual spray 0.4mg / dose 200doz 10ml vial with a metering device Pharmstandart

Description

Composition
Active substance:
1000 g of the preparation contains: 4% solution of nitroglycerin – 250 g (calculated as nitroglycerin) – 10 g.
Excipients:
Ethanol – 1000 g (rectified ethyl alcohol).
Description:
Transparent colorless liquid, located in a bottle with a mechanical dosing pump. Determination is carried out immediately after opening the vial.
Product form:
Spray sublingual dosage of 0.4 mg / dose.
10 ml (200 doses) in vials of polypropylene, provided with mechanical metering pumps, nozzles and protective caps.
The vial together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity to organic nitrates; closure type of glaucoma; severe hypotension; increased intracranial pressure caused by bleeding in the brain or trauma; simultaneous reception of phosphodiesterase inhibitors; age 18 years (lack of sufficient clinical data).
Precautions: acute myocardial infarction with low filling pressure of the left ventricle (risk reduction in blood pressure and tachycardia which can enhance ischemia), chronic heart failure with low filling pressure of the left ventricle, severe anemia, thyrotoxicosis, hypertrophic cardiomyopathy (possibly increased frequency of angina attacks), heavy renal failure, hepatic failure (risk of methemoglobinemia).
Dosage
0.4 mg / dose
Indications
Prevention of angina attacks by use of prophylactic drug before exercise; relief of angina; acute left ventricular failure (including acute myocardial infarction).
Interaction with other drugs
Other vasodilators and antihypertensives drugs (beta-blockers, blockers “slow” calcium channel blockers), angiotensin-converting enzyme (ACE) inhibitors, antipsychotics, tricyclic antidepressants, inhibitors of monoamine oxidase (MAO), procainamide and ethanol can strengthen the hypotensive effect of nitroglycerin.
Nitroglycerine dihydroergotamine increases efficiency and reduces the effect of heparin. Against the background of quinidine and procainamide may cause orthostatic collapse.
Simultaneous treatment with inhibitors of phosphodiesterase type 5 (PDE 5) – sildenafil, tadalafil, vardenafil – can enhance the ability of the drug to reduce blood pressure.
Overdose
Symptoms: headache, decreased blood pressure, orthostatic hypotension, reflex tachycardia, dizziness, facial flushing, vomiting and diarrhea, fatigue, increased sleepiness, feeling of heat. Extremely high doses (20 mg / kg) cause methemoglobinemia, cyanosis, dyspnea and tachypnea, orthostatic collapse.
Treatment: In mild cases – transfer of the patient in the supine position with legs raised. In severe manifestations overdose should be used general methods of treatment toxicity and shock (replenishment volume of circulating blood norepinephrine and / or dopamine et al.).
Application of epinephrine (adrenaline) is contraindicated.
The following antidotes and methods of treatment can be used in the development of methemoglobinemia: 1. Vitamin C – 1 g of a sodium salt or intravenously. 2. Methylene Blue intravenously at a dose of 50 ml of a 1% solution. 3. Toluidine blue intravenously, the first dose of 2-4 mg / kg, then multiply by 2 mg / kg. 4. Oxygen therapy, hemodialysis, transfusion (exchange) of blood.
pharmachologic effect
Pharmacological group:
Vasodilating agent – nitrate.
Pharmacological properties:
Nitroglycerine – organic nitrogen-containing compound with a primary venodilatiruyuschim action.
Pharmacodynamics:
Effects of nitroglycerin due to its ability to release molecules from the nitrogen oxide, which is the natural endothelial relaxing factor. Nitric oxide enhances the intracellular concentration of cyclic guanozinmonofosfatazy that prevents the penetration of calcium ions into smooth muscle cells and causes their relaxation. Relaxation of smooth muscles of the vascular wall causes vasodilatation, which reduces the venous return (preload) and the resistance of the systemic circulation (afterload). This reduces cardiac work and myocardial oxygen demand. Expansion coronary improves coronary blood flow and promotes its redistribution in reduced blood circulation, thereby increasing oxygen delivery to the myocardium.
Reducing venous return results in a reduction of the filling pressure, improving blood supply subendocardial layers reduce the pressure in the pulmonary circulation and regression of symptoms of pulmonary edema. Nitroglycerine has central inhibitory effect on sympathetic vascular tone, inhibiting the formation of vascular component of pain. Nitroglycerine relaxes bronchial smooth muscle cells, urinary tract, gallbladder, bile ducts, esophagus, small intestine and colon. The action begins quickly, the effect develops within 1-1.5 minutes and lasts for about 30 minutes.
Pharmacokinetics:
Nitroglycerine with sublingual application rapidly and completely absorbed from the oral cavity into the systemic circulation. Bioavailability is 100% when sublingual have been excluded “primary” hepatic degradation of the drug. The maximum plasma concentration is reached after 4 minutes. Communication with plasma proteins is 60%. Rapidly metabolized involving nitrate to form di- and mononitrate (only active isosorbide-5-mononitrate), the final metabolite – glycerol. Excreted by the kidneys in the form of metabolites. The total clearance is 25-30 l / min. After drug administration under the tongue half-life of plasma is 2,5-4,4 minutes. Circulating nitroglycerin strongly linked to red blood cells and builds up in the walls of blood vessels. The primary route of elimination of nitroglycerin – Extraction of metabolites in the urine; less than 1% of the dose is excreted unchanged.
Pregnancy and breast-feeding
No data on the penetration of nitroglycerin in breast milk.
Application of pregnancy and during breastfeeding requires careful matching of risk and benefit, and should be under strict medical supervision.
Conditions of supply of pharmacies
Without recipe.
side effects
Cardio-vascular system: dizziness, headache, tachycardia, fever, decreased blood pressure; rare (especially in overdose) – Orthostatic hypotension, cyanosis.
From the digestive system: dry mouth, rarely – nausea, vomiting, abdominal pain.
On the part of the central nervous system: weakness, rare – anxiety, psychotic reactions, lethargy, disorientation.
Allergic reactions: seldom – skin rash, itching.
Local reactions: skin redness, burning under the tongue.
Other: rarely – blurred vision, hypothermia, methemoglobinemia.
special instructions
Nitroglycerine enhances catecholamine excretion and vanilinmindalnoy acid excretion.
Use of alcoholic beverages during the use of the drug is strictly prohibited.
Effect on vehicle driving and work that requires attention
At the beginning of treatment should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions. Subsequently degree of limitation is determined individually for each patient.
Storage conditions
In the dark place, away from the fire, at a temperature not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
The drug is recommended to take a doctor’s prescription in order to avoid complications.
Relief of angina attack
The first attack of angina apply 1 or 2 doses sublingually. If necessary, you can re-apply to the 5-minute intervals. If, after receiving three doses within 15 minutes of an attack are not cropped, you should immediately consult a doctor.
C 1 prophylactic dose is used in 5-10 minutes before the expected load or stress.
The highest single dose of 4 doses. Higher daily doses of 16 doses.
Terms of taking the medication: If possible sit remove the protective cap from the bottle, hold the bottle upright, open your mouth and hold your breath for a few seconds, click once on the balloon, sending a stream of medication under the tongue, close your mouth and try not to ingest the drug.
At first use or after long periods of non-use is recommended before actually using one dose reset in air for filling aerosol chamber.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist