Instructions for use Rimantadine-KR tablets 0.05 g blister No. 20
Composition
active ingredient: rimantadine hydrochloride;
1 tablet contains rimantadine hydrochloride – 0.05 g;
excipients: lactose monohydrate, potato starch, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a yellowish tint.
Pharmacotherapeutic group
Direct-acting antivirals.
ATX code J05A C02.
Pharmacological properties
Pharmacodynamics.
Rimantadine hydrochloride is a derivative of amantadine, has a pronounced antiviral activity. It is effective against various influenza A viruses, and also exhibits an antitoxic effect in influenza caused by type B viruses. Rimantadine inhibits virus replication in the early stages of the cycle by disrupting the formation of the viral envelope. Genetic experiments have shown that the specific protein of the M2 gene of the virion is of great importance in the antiviral action of rimantadine against influenza A virus. In vitro, rimantadine inhibits the replication of all three antigenic subtypes (H1N1, H2N2, H3N3) of the influenza virus identified in humans. Rimantadine does not affect the immunogenic properties of the inactivated influenza A vaccine.
Rimantadine is also effective against arboviruses, which are the causative agents of tick-borne encephalitis.
Pharmacokinetics.
After single and multiple administration of the drug by patients of different age groups, no correlation has been established between the concentration of rimantadine in blood plasma and its antiviral activity.
After oral administration, the drug is almost completely absorbed.
Adsorption is slow. Binding to blood plasma proteins is about 40%.
Metabolized in the liver. Half-life is 24-36 hours; 75-85% of the dose is excreted by the kidneys, mainly as metabolites, 15% as unchanged drug.
In chronic renal failure, the half-life increases by 2 times. In people with renal failure and in the elderly, the concentration of the active substance may increase to a toxic level.
In patients with chronic liver disease of mild to moderate severity, dose reduction is not required.
Indication
Early treatment and prevention of influenza during an epidemic in adults and children aged 7 years and older.
Contraindication
Hypersensitivity to components of the adamantane group and to any of the components of the drug.
Acute and chronic liver diseases, acute and chronic kidney diseases, thyrotoxicosis.
Special safety precautions
Rimantadine-KR should be prescribed with caution to patients with gastrointestinal diseases, liver dysfunction, severe heart diseases and heart rhythm disorders, and the elderly. In these cases, a dose reduction is recommended.
If there is a history of epilepsy and anticonvulsant therapy, the risk of developing an epileptic seizure increases when using rimantadine. In this case, the dose of the drug should be reduced to 100 mg per day. If a seizure develops, the drug should be discontinued.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Interaction with other medicinal products and other types of interactions
Rimantadine-KR enhances the stimulating effect of caffeine and reduces the effectiveness of antiepileptic drugs.
Adsorbents, binders and enveloping agents reduce the absorption of Rimantadine-KR.
Cimetidine may enhance the effect of the drug.
Agents that acidify urine (ammonium chloride, paracetamol, ascorbic acid, etc.) reduce the effectiveness of Rimantadine-Kr due to its faster excretion by the kidneys.
Urine alkalizing agents (diacarb, sodium bicarbonate, etc.) increase the effectiveness of Rimantadine-KR due to a decrease in its excretion by the kidneys.
You should refrain from consuming beverages containing alcohol, as adverse reactions from the central nervous system may occur.
Use during pregnancy or breastfeeding
Rimantadine-KR is contraindicated for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of administration and doses
Take the tablets orally after meals, with water.
The use of Rimantadine-KR should be started immediately after the first symptoms of influenza appear. The therapeutic effect is more pronounced if the drug is started within the first 48 hours.
Treatment of influenza: adults and children over 14 years of age: on the first day - 100 mg (2 tablets) 3 times a day, on the 2nd and 3rd days - 100 mg (2 tablets) 2 times a day, on the 4th and 5th days - 100 mg (2 tablets) 1 time a day.
Before using the drug in children, you should definitely consult a doctor.
Children aged 7-10 years - prescribe 50 mg (1 tablet) 2 times a day;
11-14 years old – 50 mg (1 tablet) 3 times a day. Duration of treatment is 5 days.
Elderly patients (over 65 years old) 100 mg (2 tablets) once a day.
The duration of treatment is 5 days.
Flu prevention: adults and children aged 7 years and over, 50 mg (1 tablet) once a day. Duration of treatment: up to 15 days.
The drug should be started at the same time as the flu epidemic begins and used during the flu epidemic.
Children
Use in children under 7 years of age is contraindicated.
Overdose
In cases of overdose, symptomatic therapy is used to support vital body functions.
There is information about a case of poisoning with a chemical analogue - amantadine.
Symptoms: agitation, hallucinations, heart rhythm disturbances, fever, chills, sweating, arrhythmia, hypoesthesia, increased lacrimation, dysphagia, constipation, increased urination, stomatitis, eye pain.
Treatment: drug withdrawal, gastric lavage, intravenous administration of physostigmine to children – 0.5 mg, if necessary repeated administration, but not more than 2 mg/h. Rimantadine and amantadine are not removed by hemodialysis.
Side effects
Rimantadine-KR is usually well tolerated.
Classification of adverse reactions by frequency of development: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000).
Gastrointestinal disorders: often - dyspepsia (nausea, vomiting), infrequently - abdominal pain, diarrhea, indigestion, dry mouth, anorexia.
Neurological disorders: often - insomnia, infrequently - impaired concentration, dizziness, headache, increased fatigue, tremor, hallucinations, seizures, confusion, ataxia (impaired coordination of movements), drowsiness, increased excitement, depression, euphoria, hyperkinesis (spontaneous movements), change/loss of taste, parosmia.
Cardiac disorders: infrequently - palpitations, heart failure, edema, cardiac conduction disorders (blockade), tachycardia.
Vascular disorders: uncommon - arterial hypertension, cerebrovascular disorders, syncope.
Reproductive system and breast disorders: uncommon – galactorrhea.
Hearing and vestibular disorders: uncommon – tinnitus/ringing in the ears.
Respiratory, thoracic and mediastinal disorders: infrequently - cough, dyspnea (shortness of breath), bronchospasm.
Skin and subcutaneous tissue disorders: uncommon – rash, itching, urticaria.
Immune system disorders; skin and subcutaneous tissue disorders: uncommon - pallor of the skin, possible hypersensitivity reactions, including skin rashes, itching, urticaria.
General disorders: infrequently - asthenia (weakness), exacerbation of concomitant chronic diseases.
Usually, side effects disappear after you stop taking the drug.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in original packaging at a temperature not exceeding 25 0C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 2 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Address
61010, Ukraine, Kharkiv, 1 Hordienkivska St.
