Erynit (Tablets) Instructions for Use

ATC Code

C01DA05 (Pentaerithrityl tetranitrate)

Active Substance

Pentaerithrityl tetranitrate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Peripheral vasodilator. Anti-anginal drug

Pharmacotherapeutic Group

Drugs for the treatment of heart diseases; vasodilators for the treatment of heart diseases; organic nitrates

Pharmacological Action

Peripheral vasodilator with a predominant effect on venous vessels, an anti-anginal agent.

The action is associated with a reduction in preload (dilation of peripheral veins and reduction of blood flow to the right atrium) and afterload (reduction of total peripheral vascular resistance), as well as a direct coronary vasodilating effect.

It promotes the redistribution of coronary blood flow to areas with reduced blood supply.

In patients with coronary artery disease, angina pectoris, it increases tolerance to physical exertion.

In heart failure, it promotes myocardial unloading by reducing preload.

It reduces pressure in the pulmonary circulation.

Compared to nitroglycerin, the action develops more slowly but is characterized by a longer duration.

Pharmacokinetics

When taken orally, Pentaerithrityl tetranitrate is slowly absorbed from the gastrointestinal tract.

Indications

Prevention of angina attacks.

ICD codes

Dosage Regimen

Administer orally. Swallow the tablet whole with a sufficient amount of liquid.

Initiate therapy at a low dose and titrate upward based on clinical response and tolerability.

The typical adult dosage for angina prophylaxis is 10 mg to 20 mg, taken three to four times daily.

For long-term management, a total daily dose of 40 mg to 80 mg, divided into multiple doses, may be used.

Adhere to a consistent dosing schedule, preferably 30 to 60 minutes before anticipated physical exertion or stressful events known to provoke angina.

Do not use this medication for the acute relief of an ongoing angina attack due to its slow onset of action.

To minimize the risk of developing tolerance, implement a daily nitrate-free interval of approximately 10 to 12 hours, often overnight.

Adjust the dosage regimen with caution in elderly patients due to an increased predisposition to hypotension and dizziness.

Regularly monitor blood pressure and heart rate, especially during the initial phase of treatment and following any dosage adjustments.

Abrupt discontinuation of therapy is not recommended; gradually reduce the dose under medical supervision.

Adverse Reactions

From the digestive system nausea, diarrhea.

From the CNS headache, tinnitus, dizziness, weakness, increased fatigue, anxiety.

From the cardiovascular system tachycardia, decreased blood pressure, orthostatic hypotension.

Other increased sweating, allergic reactions, skin hyperemia.

Contraindications

Hypersensitivity to pentaerithrityl tetranitrate; severe arterial hypotension (systolic blood pressure below 90 mm Hg, diastolic blood pressure below 60 mm Hg), collapse, shock, acute myocardial infarction with hypotension, hemorrhagic stroke, traumatic brain injury, closed-angle glaucoma, severe hepatic insufficiency, severe renal insufficiency, severe anemia, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe stenosis of the aortic and/or mitral valve, hyperthyroidism, primary pulmonary hypertension, chronic heart failure with low left ventricular filling pressure, simultaneous use of PDE5 inhibitors (including sildenafil, vardenafil, tadalafil); children and adolescents under 18 years of age.

With caution in cases of predisposition to arterial hypotension in elderly individuals, dehydrated patients; with a history of predisposition to orthostatic hypotension.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in patients with severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in patients with severe renal insufficiency.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Should be used with caution in cases of predisposition to arterial hypotension in elderly individuals.

Special Precautions

Due to the slow development of the effect, Pentaerithrityl tetranitrate is not used to relieve angina attacks.

Use with caution in cases of cerebrovascular accidents (especially hemorrhagic stroke), and in cases of predisposition to arterial hypotension in elderly individuals.

With prolonged use, a decrease in the therapeutic effect is possible (due to the development of tolerance). When using the drug once a day in combination with other anti-anginal drugs, the risk of developing tolerance is lower.

Alcohol consumption is contraindicated during treatment.

Influence on the ability to drive vehicles and mechanisms

During the use of pentaerithrityl tetranitrate, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Under the influence of dihydroergotamine, a decrease in the anti-anginal effect of pentaerithrityl tetranitrate is possible.

An enhancement of the hypotensive effect is possible with simultaneous use with vasodilators and antihypertensive agents (beta-blockers, calcium channel blockers, etc.), antipsychotics, tricyclic antidepressants, MAO inhibitors, procainamide, ethanol, phosphodiesterase-5 inhibitors.

With simultaneous use of pentaerithrityl tetranitrate with anaprilin, the anti-anginal action is enhanced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.