Nitroglycerin - instructions for use, dose, side effects, contraindications

Excipients: dextrose monohydrate (glucose) 0.0095 g, lactose monohydrate (sugar milk) 0.0428 g, potato starch 0.0131 g, calcium stearate 0.0006 g, microcrystalline cellulose 0.0035 g.

Description:

Tablets are white, flat-cylindrical, with a bevel.

Pharmacotherapeutic group:vasodilator - nitrate

ATX: & nbsp

C.01.D.A.02 Nitroglycerine

Pharmacodynamics:

Peripheral vasodilator with predominant effect on venous vessels. The effect of nitroglycerin is mainly due to a decrease in myocardial oxygen demand due to a reduction in preload (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, an attack of angina usually stops after 1.5 minutes, the antianginal effect persists for 30 to 60 minutes.

Pharmacokinetics:

Quickly and completely absorbed from the surface of the mucous membranes of the mouth. With sublingual admission nitroglycerine immediately enters the systemic circulation, bioavailability is - 100%. The time to reach the maximum concentration in the blood plasma is determined after 5 minutes. Has a very large volume of distribution. The connection with plasma proteins is 60%.

Indications:

Stenocardia, short-term prophylaxis of angina attacks before physical exertion or emotional stress.

Contraindications:

- Simultaneous administration of inhibitors of phosphodiesterase-5 (sildenafil, vardenafil, tadalafil);

- hypersensitivity to nitrates and other components of the drug;

- lactose intolerance, lactase deficiency and glucose-galactose malabsorption;

- age under 18 years (effectiveness and safety not established);

- shock;

- collapse.

Carefully:

Comparing the risk and benefit assigned to patients with:

- hemorrhagic stroke,

- intracranial hypertension,

- acute myocardial infarction with low left ventricular filling pressure (risk of lowering blood pressure (BP) and tachycardia, which may increase ischemia),

- chronic heart failure with low left ventricular filling pressure,

- angle-closure glaucoma (risk of increased intraocular pressure),

- severe anemia,

- thyrotoxicosis,

- arterial hypotension with low systolic blood pressure (below 90 mm Hg) (can aggravate the condition, causing paradoxical bradycardia and angina attacks),

- hypertrophic obstructive cardiomyopathy (there may be more episodes of angina pectoris);

- severe renal failure,

- hepatic insufficiency (risk of development of methemoglobinemia),

- recently suffered head trauma,

- idiopathic hypertrophic subaortic stenosis,

- conditions accompanied by a decrease in the filling pressure of the left ventricle - isolated mitral stenosis,

- constrictive pericarditis,

- cardiac tamponade.

- diabetes.

Pregnancy and lactation:

Use during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus / child.

At the time of application of the drug, it is recommended to stop breastfeeding.

Dosing and Administration:

Nitroglycerin should be taken at the first sign of an angina attack or before the expected physical exertion or emotional stress: 1 tablet of nitroglycerin is placed under the tongue and kept until completely dissolved, without swallowing. The usual dose of the drug is 1 tablet under the tongue.

If the attack of angina is not stopped within 5 minutes, you need to take another 1 tablet of the drug nitroglycerine.

In the absence of therapeutic effect after taking 2 tablets, you must call a doctor.

Side effects:

From the side of the heart-cardiovascular system: tachycardia, redness of the skin of the face, fever, reduction of blood pressure; rarely (especially with an overdose) - orthostatic collapse, cyanosis.

From the gastrointestinal tract: dryness of the oral mucosa, nausea, vomiting, pain in the stomach.

From the central nervous system: rarely (especially with an overdose) - anxiety, psychotic reactions, inhibition, disorientation, blurred vision, "nitrate" headache (especially at the beginning of the course of treatment,with prolonged therapy decreases), dizziness and a sense of weakness.

On the part of the organs of hematopoiesis: methemoglobinemia.

Possible allergic reactions, hypothermia.

Overdose:

Symptoms: lowering blood pressure (below 90 mm Hg) with orthostatic dysregulation, reflex tachycardia, headache, severe dizziness, dyspnea, severe weakness, convulsions, asthenia, increased drowsiness, a feeling of heat, nausea, vomiting. When using high doses (more than 20 mg / kg) - collapse, cyanosis, methemoglobinemia, dyspnea and tachypnea.

When there are symptoms of an overdose immediately put the patient, raise his legs. Urgently call a doctor.

Interaction:

The hypotensive effect of nitroglycerin intensified when used simultaneously with:

- vasodilators;

- antihypertensive drugs;

- inhibitors of the angiotensin-converting enzyme;

- beta-blockers;

- blockers of "slow" calcium channels;

- procainamide;

- tricyclic antidepressants;

- monoamine oxidase inhibitors;

- inhibitors of phosphodiesterase-5 (sildenafil, vardenafil, tadalafil);

- ethanol;

- diuretics.

The simultaneous use of nitroglycerin with dihydroergotamine can lead to increase the content of the latter in the blood and the increase in blood pressure (increased bioavailability of dihydroergotamine).

Simultaneous use of nitroglycerin and heparin reduces the effectiveness of the latter (after drug cancellation, a significant reduction in blood coagulability, which may require a reduction in the dose of heparin).

Special instructions:

Against the background of taking nitroglycerin, a significant reduction in blood pressure and the appearance of dizziness during a sudden transition from the "sitting" or "lying" position are possible; at the use of alcohol, performance of physical exercises and hot weather.

With prolonged use, habituation develops, and an increase in dosage is required.

Severity of headache against the background of taking nitroglycerin can be reduced by lowering its dose and / or concurrent administration of Validol.

If blurred vision or dryness of the oral mucosa is retained or severely expressed, treatment should be discontinued, and a doctor's consultation is necessary.

With frequent attacks of angina pectoris, it is advisable to use prolonged forms of nitroglycerin.

Patients with diabetes should take into account that one tablet of nitroglycerin contains 1.5 mg of dextrose monohydrate (glucose), which corresponds to 0.0008 XE.

Effect on the ability to drive transp. cf. and fur:

When taking the drug, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions (with dizziness, feelings of weakness, inhibition, blurred vision).

Form release / dosage:

Tablets are sublingual, 0.5 mg.

Packaging:

For 40, 50 or 100 tablets in cans, vials or test tubes are polymeric.

To the bank, a vial or a test tube together with the instruction for use is placed in a pack of cardboard.

It is allowed to place cans, vials or test tubes together with an equal number of instructions for use in group packaging.

Storage conditions:

In a place protected from light, away from fire, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

After the expiry date, the drug should not be used.

Terms of leave from pharmacies:Without recipe

Registration number:P N003675 / 01

Date of registration:10.08.2009 / 20.11.2015

The owner of the registration certificate:MEDISORB, CJSC MEDISORB, CJSC Russia

Manufacturer: & nbsp

MEDISORB, CJSC Russia

Information update date: & nbsp11.03.2016

Illustrated instructions

Instructions

Nitroglycerine (Nitroglycerin)