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

Description:Polymeric films are oval in shape, from white with a yellowish tinge to a light yellow color (for a dosage of 1 mg) or from light green to green (for a dosage of 2 mg).

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). Promotes the redistribution of coronary blood flow to the ischemic areas of the myocardium.Increases tolerance to physical activity in patients with coronary heart disease and angina pectoris. Reduces pressure in a small circle of blood circulation. Polymer biodegradable films have good adhesive properties, instantly glued to the oral mucosa. Due to the presence in the hydrophilic matrix of solid fat (cocoa butter) having hydrophobic properties, conditions for controlled release of nitroglycerin are created in the film swollen from the saliva.

The film trinitrolonga is able to stop an attack of angina in 1-1.5 minutes.

Depending on the individual characteristics of dissolution of the polymer film and the dose used, the duration of antianginal and anti-ischemic effects is on average 3-5 hours.

It is important that intermittent administration of the drug during the day allows to avoid the occurrence of tolerance to nitrates. In addition, the effect remains stable almost to the very end of resorption of the film. The 3-month course of trinitrolong has a more pronounced and stable antianginal and anti-ischemic effect. However, the development of tolerance to it is not observed.

The dose of the drug is selected individually depending on the required time of resolution of the film in a particular patient: a film with 1 mg - with resorption for 1-1.5 hours, with 2 mg - 2-3 hours.

Pharmacokinetics:2 minutes after gluing the film on the gum, the concentration in the blood averages 0.9 ± 0.5 mg / ml, after 10 minutes - 0.9 ± 15 mg / ml, remaining at this level for 3 hours.

Indications:

Applied for the prevention and relief of angina attacks.

Contraindications:

Hypersensitivity to nitrates, shock, collapse, severe arterial hypotension (systolic blood pressure less than 100, diastolic arterial pressure 60 mm Hg), simultaneous use of phosphodiesterase 5 inhibitors (such as sildenafil, varnenafil or tadalafil), because they potentiate the hypotensive effect of nitrates, age under 18 years (efficacy and safety are not established), the patient has inflammatory changes in the oral mucosa, especially the upper gums (gingivitis, aphthous stomatitis).

Carefully:

Pulmonary edema.

Cranial hypertension, cardiac tamponade, uncontrolled hypervolemia,in patients with heart failure with normal or low pressure in the pulmonary artery, arterial hypotension (systolic blood pressure below 90 mm Hg), closed-angle glaucoma with high intraocular pressure, severe anemia, hypothyroidism, acute myocardial infarction with low filling pressure of the left ventricular, toxic pulmonary edema, subarachnoid hemorrhage, recently suffered trauma to the skull, hemorrhagic stroke, a condition accompanied by a decrease in left ventricular filling pressure (from oligylated mitral stenosis, constrictive pericarditis), idiopathic hypertrophic subaortic stenosis, impaired cerebral circulation, severe renal and / or hepatic insufficiency (risk of methaemoglobinaemia).

Cautiously appoint in hypertrophic cardiomyopathy because of the danger of paradoxical reactions.

Pregnancy and lactation:

The use of Trinitrolong during pregnancy and breastfeeding is possible only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

Trinitrolong is recommended for taking the doctor's prescription.

Initially, a dose of Trinitrolonga is chosen by a doctor (films containing 1 mg or 2 mg). Later the patient takes the medication alone. To do this, the film is glued to the oral mucosa, usually in the area of the upper gum. To do this, immediately after the onset of pain, press the film with your finger to the gum for several seconds and leave until dissolved. If it is necessary to increase the flow of nitroglycerin into the blood, lick the film 2-3 times with the tongue, without moving it from the spot.

If the pain quickly passes, the rest of the film that does not have time to resolve, it is recommended to remove.

In the absence of antianginal action during the first 5 minutes, it is recommended to paste another film on the gum.

If there is no therapeutic effect, after applying 2 films, the doctor should be consulted immediately.

Side effects:

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

From the cardiovascular system: lowering blood pressure, tachycardia, rarely (especially with an overdose) orthostatic collapse, cyanosis, reddening of the facial skin.

From the gastrointestinal tract: dry mouth, nausea, vomiting, abdominal pain.

The place of gluing the film may cause a sensation of cold and light tingling.

Allergic reactions, hypothermia are possible.

Overdose:

Symptoms: lowering blood pressure (below 90 mm Hg) with orthostatic dysregulation, severe dizziness, headache, fainting, shortness of breath, severe weakness, palpitations, fever, seizures, asthenia, drowsiness. At application of high doses - a collapse, a cyanosis, a methemoglobinemia, a dyspnea and tachypnea.

Treatment: When there are symptoms of an overdose immediately put the patient to raise his legs and urgently call a doctor.

Interaction:

The hypotensive effect of the drug may be excessive in the case of uncontrolled simultaneous administration of vasodilators, hypotensive agents, phosphodiesterase inhibitors, slow calcium channel blockers, tricyclic antidepressants, ethanol, diuretics, beta adrenoblockers, monoamine oxidase (MAO) inhibitors, procainamide.

The appointment with dihydroergotamine can lead to an increase in its content in the blood and an increase in blood pressure (due to an increase in the bioavailability of dihydroergotamine).

Against the background of quinidine and novocainamide, orthostatic collapse may occur.

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

Special instructions:

Patients previously treated with organic nitrates may need a higher dose to obtain the desired hemodynamic effect.

Against the background of taking nitroglycerin, angina is also possible with a sharp decrease in blood pressure, ischemia, up to myocardial infarction and sudden death (paradoxical nitrate reactions).

Against the backdrop of the use of Trinitrolong, a significant reduction in blood pressure and the appearance of dizziness can occur with a sharp transition to the vertical position from the "lying" or "sitting" position; when drinking alcohol, doing physical exercises and in hot weather.

To the Trinitrogologist, as well as to other organic nitrates, with frequent use, habituation may develop, which does not require a higher dosage.

If blurred vision or dry mouth persists or is severe, treatment should be discontinued.

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

If the film in the oral cavity swells, but does not resolve, this may indicate the end of the shelf life of the drug.

Effect on the ability to drive transp. cf. and fur:When driving vehicles and controlling mechanisms that require increased attention, it should be borne in mind that the use of Trinitrolong can lead to a slowing of the speed of motor and mental reaction.

Form release / dosage:

Films for gluing on the gum, 1 mg and 2 mg.

Packaging:

10 films in a planar cell package.

1 or 3 contour packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001034/10

Date of registration:16.02.2010 / 24.12.2014

Expiration Date:Unlimited

The owner of the registration certificate:Progress RCC, JSCProgress RCC, JSC Russia

Manufacturer: & nbsp

Progress RCC, JSC Russia

Information update date: & nbsp30.12.2016

Illustrated instructions

Instructions

Trinitrolong (Trinitrolongum)