Nitroglycerin 0.5 mg tablets No. 40

Author Ольга Кияница

2017-05-11

Amount in a package 40
Product form Pills
Manufacturer Technologist ZAO (Ukraine, Uman)
Registration certificate UA6393/01/01
The main medicament Nitroglycerine
morion code 41715

Nitroglycerin (Nitroglicerin) instructions for use

Composition of the medicinal product:

active ingredient: 1 sublingual tablet contains nitroglycerin 2% on lactose in terms of nitroglycerin 0.5 mg;
auxiliary substances: lactose monohydrate, povidone 25, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Dosage form

Tablets sublingual.

Single-layer tablets are round in shape, with flat top and bottom surfaces, the edges of which are beveled, with a stroke, white or white with a cream-colored hue. Marble is allowed on the surface of the tablets. On the fracture under the magnifier, a relatively homogeneous structure is visible.

Pharmacotherapeutic group

Vasodilators used in cardiology. Organic nitrates. The code of automatic telephone exchange С01Б А02.

Peripheral vasodilator with predominant effect on venous vessels. The effect of nitroglycerin is mainly due to a decrease in the demand for myocardium in oxygen due to a decrease in preload (the expansion of peripheral veins and a decrease in the flow of blood to the right atrium) and postnagruzki (a decrease in the total peripheral vascular resistance).

Has a central inhibitory effect on sympathetic vascular tone, inhibiting the vascular component of the pain syndrome. It causes the expansion of meningeal vessels, which explains the headache when it is used.

When using sublingual forms, the attack of angina usually stops after 1.5 minutes, the hemodynamic and antianginal effect persists for 30 to 60 minutes.

Quickly and completely absorbed from the surface of the mucous membranes. At sublingual application at once gets to a system blood flow.

At sublingual admission in a dose of 0.5 mg bioavailability - 100%, the maximum concentration in the blood plasma is observed after 5 minutes. Communication with blood proteins is 60%.

Indications for use

Angina pectoris (for relief of angina attacks and short-term prophylaxis).

Contraindications

Hypersensitivity to nitrates, shock, collapse, arterial hypotension (systolic blood pressure below 100 mm Hg, diastolic blood pressure below 60 mm Hg), acute myocardial infarction with low left ventricular filling pressure, hypertrophic obstructive cardiomyopathy, increased intracranial pressure (including hemorrhagic stroke, after a recent head trauma), angle-closure glaucoma with high intraocular pressure, simultaneous use with sildenafil and other phosphodiesterase inhibitors, brady rdia (less than 50 bpm), cerebral ischemia, cardiac tamponade.

Appropriate safety measures for use

It is necessary to take the drug with care, taking into account the risk and benefit, taking the drug with: uncontrolled hypovolemia, heart failure with normal or low pressure in the pulmonary artery, severe anemia, hyperthyroidism, cerebral circulation disorder, severe renal and / or liver failure (risk of methaemoglobinaemia).

Use with caution in aortic stenosis, toxic pulmonary edema.

It should be used with caution in patients with severe cerebral atherosclerosis, elderly patients. Do not drink alcohol during the treatment. During treatment, it is contraindicated to visit the bath, sauna, hot shower. Tablets can not be chewed, because through the mucous membrane of the oral cavity in the systemic blood flow can enter an excessive amount of active substance.

To nitroglycerin, as well as to other organic nitrates, with frequent use can develop addiction (tolerance), which requires an increase in dosing. With prolonged use of Nitroglycerin to prevent the emergence of tolerance, it is recommended to take the drug with interruptions during the day (at intervals of 10-12 hours) or simultaneous administration of calcium antagonists, ACE inhibitors or diuretics. If necessary, with the development of tolerance, Nitroglycerin should be temporarily discontinued (for several days) and replaced with antianginal drugs of other pharmacotherapeutic groups.

The drug contains lactose, therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not use the drug.

Special caveats

Use during pregnancy or lactation.

The use of nitroglycerin during pregnancy or breast-feeding is contraindicated.

The ability to influence the reaction rate when driving or working with other machinery

When driving vehicles and mechanisms that require increased attention, remember that taking nitroglycerin can lead to a decrease in the reaction rate.

Children

Experience in using the drug for children is not, therefore, its use by this age group of patients is not recommended.

Dosing and Administration

Applied to adults.

When assigning the drug for the first time, it is necessary to investigate its effect on the level of arterial pressure.Monitoring the effectiveness of nitroglycerin should be performed on the frequency of heart rate and blood pressure.

It should be taken immediately with the first symptoms of an attack of angina pectoris.

Immediately after the onset of pain, one tablet should be placed under the tongue and kept in the mouth until it is completely absorbed, without swallowing. The usual dose of the drug is 1 tablet under the tongue. If there is no antianginal action within 3-5 minutes, you need to take another 1 tablet of Nitroglycerin.

If there is no therapeutic effect after taking 2-3 tablets, you should call a doctor.

With frequent attacks of angina, it is advisable to use drugs
prolonged action.

Overdose

Symptoms: decreased blood pressure (below 90 mm Hg) with orthostatic dysregulation, headache, severe dizziness, fainting, rapid heartbeat, nausea and vomiting, shortness of breath, severe weakness, drowsiness, fever, fever, arterial hypotension, increased sweating, chills.

When using high doses (more than 20 μg / kg) - collapse, cyanosis of the lips, nails or palms, methemoglobinemia, dyspnea and tachypnea.

Treatment: to transfer the patient to a horizontal position, to raise his legs, in severe cases appoint plasma substitutes, sympathomimetics, oxygen, with methaemoglobinemia - methylene blue.

Side effects

From the side of the central nervous system: blurred vision, headache, dizziness and a sense of weakness, anxiety, psychotic reactions, inhibition, disorientation.

From the cardiovascular system: reflex tachycardia, skin flushing, fever, arterial hypotension, including orthostatic collapse, cyanosis, pallor, methemoglobinemia.

On the part of the digestive system: nausea, vomiting, dry mouth, abdominal pain, diarrhea are possible.

From the immune system: allergic reactions, including skin rash, itching; anaphylactic shock.

Others: excitability, visual disturbances, exacerbation of glaucoma, hypothermia.

Sometimes, with a sudden drop in blood pressure, there may be an increase in the symptoms of angina pectoris (paradoxical "nitrate" reactions).

Interaction with other drugs and other interactions

With simultaneous use with other vasodilators, antihypertensive agents, ACE inhibitors, slow calcium channel blockers, phosphodiesterase inhibitors, diuretics, tricyclic antidepressants, MAO inhibitors, ethanol and ethanol-containing drugs, beta adrenoblockers, procainamides, quinidine, novocainamide, hypotensive effect of nitroglycerin.

Atropine and other drugs that detect M-holinoliticheskoe effect, can reduce the effect of nitroglycerin due to reduced secretion and bioavailability of the drug. Use with dihydroergotamine can lead to an increase in its concentration in the blood plasma and an increase in blood pressure (due to increased bioavailability of dihydroergotamine).

With simultaneous application with heparin, the anticoagulant effect of the latter can be reduced (after drug cancellation, a significant reduction in blood clotting may be required, which may require a reduction in the dose of heparin).

Phenobarbital activates the metabolism of nitrates in the liver. Alfa-adrenomimetics, histamine, pituitrin, corticosteroids, CNS stimulants, bee venom, snakes, sun rays reduce the antianginal effect of nitroglycerin. Salicylates increase the level of nitroglycerin in the blood, barbiturates accelerate its metabolism.

Donators of sulfhydryl groups (captopril, acetylcysteine, unitiol) restore reduced sensitivity to nitroglycerin.

Shelf life

2.5 years.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

40 tablets sublingual in a container; 1 container per pack.

Category of leave

Without recipe.


0.00 avg. rating (0% score) - 0 votes - votes