Corvamin (Tablets) Instructions for Use

Marketing Authorization Holder

Natur Produkt Europe, B.V. (Netherlands)

ATC Code

C01DX12 (Molsidomine)

Active Substance

Molsidomine (Rec.INN registered by WHO)

Dosage Form

Corvamin

Tablets 2 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Peripheral vasodilator. Anti-anginal drug

Pharmacotherapeutic Group

Vasodilating agent

Pharmacological Action

An anti-anginal agent from the sydnonimine group. The action of molsidomine is realized through nitric oxide (NO) formed during its metabolism, which stimulates soluble guanylate cyclase.

This leads to the accumulation of cGMP, which promotes the relaxation of vascular smooth muscle. Molsidomine causes a decrease in venous pressure, end-diastolic pressure in the ventricles, and pressure in the pulmonary artery.

It reduces myocardial oxygen demand. It dilates large coronary arteries and improves collateral circulation in coronary atherosclerosis.

In chronic heart failure, molsidomine reduces ventricular dilation.

Pharmacokinetics

After oral administration, molsidomine is almost completely (90%) absorbed from the gastrointestinal tract. Food intake does not affect the extent and rate of absorption. Plasma protein binding is about 10%.

It is metabolized in the liver to form active metabolites (mainly linsidomine, i.e., SIN-1 A, which releases NO), which are then inactivated. Molsidomine and its metabolites are mainly excreted in the urine (90%).

T_1/2 increases with impaired liver function.

Indications

Prevention and long-term treatment of stable angina pectoris in adults in case of insufficient effectiveness, contraindications to the use, or intolerance of other anti-anginal drugs (such as beta-blockers and/or calcium channel blockers), as well as in older patients.

ICD codes

Dosage Regimen

Determine the dosage individually based on clinical response and tolerability.

For the initiation of therapy, start with a dose of 1 mg two to three times daily.

Titrate the dose gradually if a higher therapeutic effect is required. The typical single dose range is 1 mg to 4 mg.

Administer the drug two to three times per day to maintain a continuous anti-anginal effect.

The maximum daily dose should generally not exceed 12 mg.

For elderly patients and patients with impaired liver function, initiate therapy at the lower end of the dosage range due to a potential increase in the elimination half-life.

Exercise caution and consider a lower starting dose in patients with arterial hypotension or impaired renal function.

Take tablets orally, with or without food, as food intake does not significantly affect absorption.

Adverse Reactions

From the cardiovascular system: at the beginning of treatment, headaches may occur (which cease during therapy); rarely – facial flushing, orthostatic hypertension.

From the digestive system: nausea, diarrhea, loss of appetite may occur.

Contraindications

Hypersensitivity to molsidomine; cardiogenic shock, pronounced arterial hypotension, decreased central venous pressure, glaucoma; simultaneous use of nitric oxide donors in any form and stimulators of soluble guanylate cyclase (riociguat) due to the high risk of developing arterial hypotension.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Dose adjustment is required for elderly patients with impaired liver function.

Use in Renal Impairment

Dose adjustment is required for elderly patients with impaired renal function.

Pediatric Use

Used in adult patients.

Geriatric Use

Dose adjustment is required for elderly patients with impaired liver or kidney function and arterial hypotension.

Special Precautions

Use with special caution in patients after a recent myocardial infarction.

Dose adjustment is required for elderly patients with impaired liver or kidney function and arterial hypotension.

Effect on the ability to drive vehicles and operate machinery

During the use of molsidomine (especially at the beginning of treatment), one should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use with antihypertensive and vasodilating agents, an enhancement of the antihypertensive effect is possible.

Concomitant use of molsidomine may potentiate the antihypertensive effect of soluble guanylate cyclase stimulators (such as riociguat) with the development of severe arterial hypotension.

With simultaneous use with acetylsalicylic acid, the antiplatelet effect of acetylsalicylic acid is enhanced.

With simultaneous use with ethanol, the risk of arterial hypotension increases.

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.