Rimantadine (Tablets, Syrup) Instructions for Use
ATC Code
J05AC02 (Rimantadine)
Active Substance
Rimantadine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antiviral drug
Pharmacotherapeutic Group
Systemic antiviral agents; direct-acting antiviral agents; 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, allowing its use not only for therapeutic but also for prophylactic purposes. It suppresses the early stage of specific replication (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%. Vd in adults is 17-25 L/kg, in children – 289 L. The concentration in nasal secretions is 50% higher than plasma concentration. The Cmax value after a single dose of 100 mg is 181 ng/mL, after 100 mg twice daily is 416 ng/mL. It is metabolized in the liver. T1/2 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
| ICD-10 code | Indication |
| J10 | Influenza due to identified seasonal influenza virus |
| Z29.8 | Other specified prophylactic measures |
| ICD-11 code | Indication |
| 1E30 | Influenza due to identified seasonal influenza virus |
| QC05.Z | Prophylactic measures, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally. Initiate treatment within 24-48 hours of influenza symptom onset for maximum therapeutic benefit.
For treatment of influenza A in adults: take 100 mg twice daily. A single daily dose of 100 mg may be used for patients with a high risk of side effects.
For prophylaxis of influenza A in adults: take 100 mg once daily. Continue dosing for at least 10 days following known exposure; continue for up to 6 weeks during community outbreaks.
For pediatric patients (7-10 years): administer 50 mg twice daily for treatment. For prophylaxis, administer 50 mg once daily.
For pediatric patients (1-6 years): administer the syrup formulation at a dose of 2.5 mg per kg of body weight once daily. The maximum daily dose must not exceed 50 mg.
In patients with severe hepatic impairment or epilepsy, the total daily dose must not exceed 100 mg.
For geriatric patients, use the lower end of the dosing range due to potential for reduced renal function and increased risk of adverse effects.
The total duration of therapy for influenza treatment is typically 5-7 days.
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 use during lactation is necessary, 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
Can be used in children of appropriate age categories 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, exacerbation of chronic concomitant diseases is possible. In elderly patients with arterial hypertension, the risk of hemorrhagic stroke increases. In patients with a history of epilepsy and anticonvulsant therapy, the risk of an epileptic seizure increases while using rimantadine. In such cases, Rimantadine is used at a dose of up to 100 mg/day simultaneously with anticonvulsant therapy.
Prophylactic use is effective after contact with sick persons, 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 ability to drive vehicles and machinery
Patients who experience dizziness, headache, or other side effects from the central nervous system while using rimantadine should exercise caution when driving vehicles and machinery, 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) enhance its effectiveness (by reducing renal excretion).
Paracetamol and acetylsalicylic acid reduce the Cmax 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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 50 mg: 10, 20 or 30 pcs.
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Manufactured By
NPC Scan Biotek, LLC (Russia)
Dosage Form
 |
Rimantadine | Tablets 50 mg: 10, 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 41.5 mg, microcrystalline cellulose – 37.5 mg, potato starch – 19.6 mg, magnesium stearate – 1.4 mg.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
Tablets 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Rimantadine hydrochloride | 50 mg |
20 pcs. – jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell blisters.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
Tablets 50 mg: 10 or 20 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Rimantadine hydrochloride | 50 mg |
20 pcs. – jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell blisters.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
Tablets 50 mg: 10, 20, or 40 pcs.
Marketing Authorization Holder
Europharm, CJS (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, or 40 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Rimantadine hydrochloride | 50 mg |
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters.
20 pcs. – contour cell blisters (1) – cardboard packs.
20 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
20 pcs. – dark glass bottles (1) – cardboard packs.
Tablets 50 mg: 10, 20, 25, 30, 40 or 50 pcs.
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, 25, 30, 40 or 50 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical in shape.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate (milk sugar) – 60 mg, potato starch – 37 mg, calcium stearate – 1.5 mg, talc – 1.5 mg.
Weight of one tablet 150 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
25 pcs. – contour cell blisters (1) – cardboard packs.
25 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
Tablets 50 mg: 20 or 30 pcs.
Marketing Authorization Holder
Marbiopharm, JSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Rimantadine hydrochloride | 50 mg |
10 pcs. – contour cell blisters (2) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
Tablets 50 mg: 10 or 20 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white, flat-cylindrical in shape, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 74.5 mg, potato starch – 24 mg, magnesium stearate – 1.5 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
Tablets 50 mg: 20 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
 |
Rimantadine | Tablets 50 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white, flat-cylindrical in shape with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate (milk sugar) – 60 mg, potato starch – 37 mg, talc – 1.5 mg, stearic acid – 1.5 mg.
10 pcs. – contour cell blisters (2) – cardboard packs.
Tablets 50 mg: 10, 20 or 30 pcs.
Marketing Authorization Holder
PharmVILAR NPO, LLC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, with a bevel, round, flat-cylindrical.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 74.5 mg, potato starch – 24 mg, magnesium stearate – 1.5 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
Tablets 50 mg: 14, 20, or 28 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 14, 20, or 28 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 74.5 mg, potato starch – 24 mg, magnesium stearate – 1.5 mg.
10 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
Tablets 50 mg: 20 pcs.
Marketing Authorization Holder
Orange Pharma, LLC (Russia)
Manufactured By
Rozlex Pharm LLC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white, flat-cylindrical in shape, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 41.5 mg, microcrystalline cellulose – 37.5 mg, potato starch – 19.6 mg, magnesium stearate – 1.4 mg.
10 pcs. – contour cell packs (2) – cardboard packs.
Tablets 50 mg: 10 or 20 pcs.
Marketing Authorization Holder
Citypharm LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical in shape, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: potato starch – 44.3 mg, lactose monohydrate – 50 mg, povidone K17 – 4.5 mg, calcium stearate – 1.2 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
Tablets 50 mg: 10, 20, 25, 30, 50 or 100 pcs.
Marketing Authorization Holder
Tatkhimpharmpreparaty, JSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, 25, 30, 50 or 100 pcs. |
Dosage Form, Packaging, and Composition
Tablets white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine (as rimantadine hydrochloride) | 50 mg |
Excipients: lactose monohydrate, potato starch, calcium stearate, talc.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
Tablets 50 mg: 10, 20, 30, or 50 pcs.
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 52.5 mg, potato starch – 43 mg, calcium stearate – 1.5 mg, talc – 3 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Tablets 50 mg: 10, 20, 30, or 50 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Rimantadine | Tablets 50 mg: 10, 20, 30, or 50 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 74.5 mg, potato starch – 22.57 mg, talc – 1.5 mg, calcium stearate – 1.43 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
Tablets 50 mg: 10, 15, 20, 30, 40, or 60 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Form
|
Rimantadine Aktitab | Tablets 50 mg: 10, 15, 20, 30, 40, or 60 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate, potato starch, calcium stearate, talc.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
Syrup (for children) 2 mg/ml: 100 ml or 200 ml bottle
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Rimantadine Kids | Syrup (for children) 2 mg/ml: 100 ml or 200 ml bottle |
Dosage Form, Packaging, and Composition
Syrup for children as a thick, clear, colorless liquid with a fruity odor.
| 1 ml | |
| Rimantadine hydrochloride | 2 mg |
Excipients: sorbitol (liquid sorbitol) – 514.3 mg, maltitol (liquid maltitol) – 514.3 mg, carmellose sodium – 3.64 mg, methylparahydroxybenzoate – 1.15 mg, strawberry flavor – 0.63 mg, purified water – up to 1 ml.
100 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
200 ml – dark glass bottles (1) with a measuring spoon – cardboard packs.
Tablets 50 mg: 14, 20, or 28 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Rimantadine Renewal | Tablets 50 mg: 14, 20, or 28 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate, potato starch, magnesium stearate.
10 pcs. – contour cell packs (2) – cardboard packs.
14 pcs. – contour cell packs (1) – cardboard packs.
14 pcs. – contour cell packs (2) – cardboard packs.
Tablets 50 mg: 10, 20, 30 or 40 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Rimantadine Velpharm | Tablets 50 mg: 10, 20, 30 or 40 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate (milk sugar), potato starch, calcium stearate, talc.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
Tablets 50 mg: 10, 20 or 30 pcs.
Marketing Authorization Holder
Advanced Pharma, LLC (Russia)
Dosage Form
|
Rimantadine-Edvansd | Tablets 50 mg: 10, 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Tablets white or almost white, round, flat-cylindrical, with a bevel.
| 1 tab. | |
| Rimantadine hydrochloride | 50 mg |
Excipients: lactose monohydrate – 79 mg, potato starch – 19.6 mg, magnesium stearate – 1.4 mg.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – plastic jars (1) – cardboard packs.
20 pcs. – plastic jars (1) – cardboard packs.
30 pcs. – plastic jars (1) – cardboard packs.
Tablets 50 mg: 10 or 20 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Dosage Form
|
Rimantadine-STI | Tablets 50 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Rimantadine hydrochloride | 50 mg |
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
![Rimantadine [Tablets, Syrup] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Rimantadine [Tablets, Syrup] 2")