Cordinic^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pik-Pharma, LLC (Russia)

Manufactured By

Pik-Pharma Lek, LLC (Russia)

Contact Information

Pik-Pharma, LLC (Russia)

ATC Code

C01DX16 (Nicorandil)

Active Substance

Nicorandil

Dosage Forms

	Cordinic®	Tablets 10 mg: 20, 30, or 60 pcs.
		Tablets 20 mg: 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white with a slight grayish-yellowish tint, round, flat-cylindrical, with a bevel and a score on one side.

Excipients: potato starch – 5 mg, microcrystalline cellulose type 102 – 84 mg, calcium stearate – 1 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Tablets white with a slight grayish-yellowish tint, round, flat-cylindrical, with a bevel.

Excipients: potato starch – 10 mg, microcrystalline cellulose type 102 – 168 mg, calcium stearate – 2 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Peripheral vasodilator. Activator of ATP-dependent potassium channels

Pharmacotherapeutic Group

Drugs for the treatment of heart diseases; vasodilators for the treatment of heart diseases; other vasodilators for the treatment of heart diseases

Pharmacological Action

Antianginal agent, possesses nitrate-like properties and the ability to open potassium channels.

By opening potassium channels, Nicorandil causes hyperpolarization of the cell membrane, and the nitrate-like effect consists of increasing the intracellular content of cyclic guanosine monophosphate. These pharmacological effects lead to relaxation of smooth muscle cells and provide a protective effect on cardiomyocytes during ischemia.

Hemodynamic effects are expressed as a balanced reduction in preload and afterload (unlike nitrates and slow calcium channel blockers, which act mainly on preload or afterload, respectively). Considering the selective vasodilation of the coronary arteries, the load on the ischemic myocardium is ultimately minimal. Nicorandil does not affect myocardial contractility and practically does not change heart rate.

It reduces systemic blood pressure by less than 10%, has a beneficial positive effect on cerebral circulation in patients with ischemic stroke. Nicorandil does not affect lipid metabolism parameters and glucose metabolism. Nicorandil relieves an angina attack with a reduction in pain within 4-7 minutes after sublingual administration and complete relief of the attack within 12-17 minutes.

Pharmacokinetics

After oral administration, Nicorandil is rapidly and completely absorbed from the gastrointestinal tract. C_max in blood plasma is reached after 0.5-1 hour. Nicorandil slightly binds to blood plasma proteins. The free fraction in blood plasma is about 75%.

It does not undergo intensive metabolism in the liver. T_1/2 is 50 minutes. It is excreted mainly by the kidneys.

Indications

Relief of angina attacks; prevention of stable angina attacks (in combination with other antianginal agents) and as monotherapy in case of intolerance to beta-blockers and slow calcium channel blockers.

ICD codes

Dosage Regimen

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

Establish the dose individually based on disease severity and clinical response.

Initiate therapy with a single dose of 10 mg taken one to three times daily.

If well tolerated, titrate the dose upward. Increase the single dose to 20 mg for improved efficacy.

The maximum daily dose is 80 mg. Do not exceed this limit.

For headache management, reduce the initial dose. This adverse effect often diminishes with continued treatment.

Adjust the dosage regimen with caution in patients with renal impairment or hepatic impairment.

Discontinue treatment gradually. Avoid abrupt withdrawal.

Adverse Reactions

From the cardiovascular system palpitations, tachycardia, decreased blood pressure, postural hypotension, flushing, peripheral edema. When using nicorandil in a high dose, arterial hypotension and/or tachycardia is possible.

From the central nervous system headache, dizziness, tinnitus, insomnia.

From the digestive system nausea, vomiting, unpleasant sensations in the stomach, feeling of fullness in the stomach, stomatitis (very rare); in some cases – increased activity of ALT, AST, alkaline phosphatase.

From the respiratory system: bronchitis, shortness of breath, increased cough.

Allergic reactions skin rash, itching; rarely – angioedema.

Other weakness.

Contraindications

Acute myocardial infarction (and within 3 months after it); cardiogenic shock, collapse; unstable angina, including Prinzmetal’s angina; chronic heart failure of functional class III or IV according to the NYHA classification; severe bradycardia (heart rate less than 50 beats/min); AV block of II and III degree; left ventricular failure with low filling pressure; severe arterial hypotension (resting diastolic blood pressure less than 100 mm Hg); severe anemia; refractory hyperkalemia; simultaneous use of PDE5 inhibitors (sildenafil, vardenafil, tadalafil); pregnancy, lactation period (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Should be used with caution in patients with cardiac arrhythmias, impaired renal and/or liver function, hypovolemia, arterial hypotension, pulmonary edema, closed-angle glaucoma, hyperkalemia, AV block of I degree, hyperthyroidism.

Treatment should be discontinued gradually.

During treatment, blood pressure, ECG parameters, blood levels of potassium and sodium ions should be monitored; existing cardiac arrhythmias may worsen.

Effect on ability to drive vehicles and mechanisms

When driving vehicles and engaging in other potentially hazardous activities, it should be taken into account that Nicorandil may cause reduced concentration and slower psychomotor reactions.

Drug Interactions

With simultaneous use with long-acting nitrates, the development of an additive hypotensive effect is possible.

It is assumed that with simultaneous use, Nicorandil potentiates the effects of tricyclic antidepressants, antihypertensive agents and other vasodilators, as well as ethanol.

Nicorandil potentiates the hypotensive effect of PDE5 inhibitors (combination is contraindicated).

There is a report of gastrointestinal perforation with simultaneous use with corticosteroids (such combinations should be used with caution).

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.