Remantadine^® (Tablets, Capsules) Instructions for Use

ATC Code

J05AC02 (Rimantadine)

Active Substance

Rimantadine (Rec.INN WHO registered)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agent; direct-acting antiviral agent; cyclic amines

Pharmacological Action

Antiviral agent, an adamantane derivative; active against various strains of influenza A virus (especially type A₂). The polymeric structure provides long-term circulation of rimantadine in the body, which allows its use not only for therapeutic but also for prophylactic purposes. It suppresses the early stage of specific reproduction (after the virus enters the cell and before initial RNA transcription).

Being a weak base, Rimantadine acts by increasing the pH of endosomes – membrane-bound vacuoles that surround viral particles after they enter the cell. Preventing acidification in these vacuoles blocks the fusion of the viral envelope with the endosome membrane, thus preventing the transfer of viral genetic material into the cell cytoplasm. Rimantadine also inhibits the release of viral particles from the cell, i.e., interrupts the transcription of the viral genome.

Pharmacokinetics

After oral administration, it is slowly, almost completely absorbed in the intestine. Plasma protein binding is about 40%. V_d in adults is 17-25 L/kg, in children – 289 L. The concentration in nasal secretions is 50% higher than plasma concentration. The C_max value after taking 100 mg once a day is 181 ng/mL, 100 mg twice a day is 416 ng/mL. It is metabolized in the liver. T_1/2 is 24-36 hours; excreted by the kidneys (15% unchanged, 20% as hydroxyl metabolites).

Indications

Early treatment and prevention of influenza A in adults and children (depending on the dosage form).

ICD codes

Dosage Regimen

Take orally. Initiate therapy within 24-48 hours of influenza symptom onset.

For treatment of influenza A in adults: take 100 mg twice daily. A loading dose of 100 mg three times on the first day may be used.

For prophylaxis of influenza A in adults: take 100 mg once daily.

For treatment in children aged 7 to 10 years: take 50 mg twice daily.

For treatment in children aged 10 to 14 years: take 50 mg three times daily.

For prophylaxis in children aged 7 to 10 years: take 50 mg once daily.

For prophylaxis in children aged 10 to 14 years: take 50 mg twice daily.

The standard treatment course is 5 days.

The standard prophylaxis course is 10-15 days during an outbreak.

In elderly patients and patients with epilepsy, do not exceed a daily dose of 100 mg.

For patients with severe hepatic impairment or renal impairment (CrCl less than 10 mL/min), reduce the dose to 100 mg once daily.

Take after meals with a full glass of water.

Adverse Reactions

From the cardiovascular system: tachycardia, heart failure, heart block, palpitations, arterial hypertension, cerebrovascular accident, loss of consciousness.

From the nervous system: insomnia, dizziness, headache, irritability, feeling of fatigue, impaired concentration, movement disorders, drowsiness, depressed mood, euphoria, hyperkinesia, tremor, hallucinations, confusion, convulsions.

From the sensory organs: tinnitus, change or loss of smell.

From the respiratory system: shortness of breath, bronchospasm, cough.

From the digestive system: nausea, vomiting, loss of appetite, dry oral mucosa, abdominal pain, diarrhea, dyspepsia.

From the skin and subcutaneous tissues: rash.

Other: allergic reactions.

Contraindications

Hypersensitivity to rimantadine; acute liver diseases, acute and chronic kidney diseases, thyrotoxicosis; pregnancy, breastfeeding period; childhood – depending on the dosage form used.

With caution in arterial hypertension, epilepsy (including history), cerebral atherosclerosis, in hepatic insufficiency, in gastrointestinal diseases; in elderly patients.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in acute liver diseases.

Use in Renal Impairment

Contraindicated in acute and chronic kidney diseases.

Pediatric Use

Use in children of appropriate age categories is possible strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the rimantadine drug leaflets regarding contraindications for the use of specific rimantadine dosage forms in children of different ages.

Geriatric Use

In elderly patients with arterial hypertension, the risk of hemorrhagic stroke increases.

Special Precautions

When using rimantadine, an exacerbation of chronic concomitant diseases is possible. In elderly patients with arterial hypertension, the risk of hemorrhagic stroke increases. In cases with a history of epilepsy and anticonvulsant therapy, the use of rimantadine increases the risk of an epileptic seizure. In such cases, Rimantadine is used at a dose of up to 100 mg/day simultaneously with anticonvulsant therapy.

Prophylactic administration is effective upon contact with sick people, when the infection spreads in closed groups, and when there is a high risk of disease during an influenza epidemic. The emergence of viruses resistant to the drug is possible.

The emergence of viruses resistant to rimantadine is possible.

For influenza caused by virus B, Rimantadine has an antitoxic effect.

Effect on the ability to drive vehicles and mechanisms

Patients who experience dizziness, headache, or other side effects from the central nervous system while using rimantadine 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

With simultaneous use, Rimantadine reduces the effectiveness of anticonvulsant drugs.

Adsorbents, astringents, and coating agents reduce the absorption of rimantadine.

Agents that acidify urine (ammonium chloride, ascorbic acid) reduce the effectiveness of rimantadine (due to increased renal excretion).

Agents that alkalize urine (acetazolamide, sodium bicarbonate) increase its effectiveness (by reducing renal excretion).

Paracetamol and acetylsalicylic acid reduce the C_max of rimantadine by 11%.

Cimetidine reduces the clearance of rimantadine by 18%.

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

Over-the-Counter

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.