Rimantadine - instructions for use, dose, side effects, contraindications

Composition:(per one tablet)
Active substance: Rimantadine hydrochloride - 50.0 mg;
Excipients: lactose monohydrate - 74.5 mg, potato starch - 24.0 mg, magnesium stearate - 1.5 mg.

Description:Round flat-cylindrical tablets of white or almost white color with a bevel.

Pharmacotherapeutic group:An antiviral agent.

ATX: & nbsp

J.05.A.C Cyclic amines

J.05.A.C.02 Rimantadine

Pharmacodynamics:Rimantadine antiviral agent, adamantane derivative; is active against various strains of the influenza A virus (especially A2 type). The polymeric structure provides a long circulation of rimantadine in the body, which makes it possible to apply it not only with a therapeutic, but also with a preventive purpose. Suppresses the early stage of a specific reproduction (after the virus enters the cell and before the initial transcription of RNA).
Being a weak ground, Rimantadine acts by increasing the pH of the endosome-membrane-vacuoles that surround the viral particles after they enter the cell. The prevention of acidification in these vacuoles blocks the fusion of the viral envelope with the endosome membrane, thus preventing the transfer of the viral genetic material to the cytoplasm of the cell. Rimantadine also inhibits the release of viral particles from the cell, i.e.interrupts the transcription of the viral genome.
The appointment of Rimantadine in a daily dose of 200 mg for 2-3 days before and 6-7 days after the onset of clinical manifestations of influenza A reduces the incidence, severity of symptoms and the degree of serological response. Some therapeutic effect may also occur if Rimantadine appointed in the next 18 hours after the onset of the first symptoms of influenza.

Pharmacokinetics:After oral administration Rimantadine almost completely absorbed in the intestine. The maximum concentration of active substance in the blood plasma after a single dose of 100 mg once a day is reached after 5-7 hours. The connection with plasma proteins is about 40%. Metabolised in the liver. It is excreted mainly by the kidneys, less than 25% of the dose - in unchanged form. The half-life is approximately 25 hours.
People with liver diseases and elderly people can accumulate in toxic concentrations if the dose is not adjusted.

Indications:Influenza A (early treatment and prevention in adults and children older than 7 years).

Contraindications:Hypersensitivity to the components of the drug.Acute liver disease, acute and chronic kidney disease, thyrotoxicosis, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, pregnancy, the period of breastfeeding, children's age (up to 7 years).

Carefully:Arterial hypertension, epilepsy (including in the anamnesis), atherosclerosis of cerebral vessels, hepatic insufficiency, patients of advanced age, diseases of the gastrointestinal tract.

Pregnancy and lactation:Rimantadine contraindicated in pregnancy and during breastfeeding.

Dosing and Administration:Rimantadine take inside (after eating), washing down with water.
Treatment of influenza should be started within 24-48 hours after the onset of symptoms of the disease. Adults are prescribed on the first day of the disease 100 mg 3 times a day; in the second and third days - 100 mg 2 times a day; on the fourth and fifth day - 100 mg once a day. On the first day of therapy, the drug can be used once in a dose of 300 mg.
Children aged 7 to 10 years are prescribed 50 mg twice a day; 10-14 years 50 mg 3 times a day; over 14 years - doses for adults. The course of treatment is 5 days.
For the prevention of influenza: adults 50 mg once a day for up to 30 days; in children older than 7 years, 50 mg once a day for up to 15 days, depending on the epidemiological situation.
For treatment of influenza in chronic renal failure (creatinine clearance less than 10 ml / min), liver failure, elderly patients - 100 mg once a day.

Side effects:From the cardiovascular system: tachycardia, heart failure, heart block (violation of the heart rhythm), palpitations, arterial hypertension, impaired cerebral circulation, loss of consciousness.
From the nervous system: insomnia, dizziness, headache, irritability, fatigue, impaired concentration, movement disorders, drowsiness, depressed mood, euphoria, hyperkinesia, tremor, hallucinations, confusion, convulsions.
From the sense organs: noise in the ears, change or loss of smell.
From the respiratory system: shortness of breath, bronchospasm, cough.
From the gastrointestinal tract: nausea, vomiting, loss of appetite, dryness of the oral mucosa, abdominal pain, diarrhea, indigestion.
From the skin and subcutaneous tissue: rash.
Other: fatigue.

Overdose:Symptoms: agitation, hallucinations, arrhythmia.In some cases, if the recommended dose is exceeded, tear eyes and eye pain, increased urination, fever, constipation, sweating, inflammation of the oral mucosa, dry skin are observed.
Treatment: gastric lavage, symptomatic therapy. When poisoning is necessary to maintain vital functions. When symptoms arise from the central nervous system, intravenous administration of physostigmine is effective: adults - 1.2 mg, children - 0.5 mg, with repeated if necessary, but not more than 2 mg / h. Rimantadine partially excreted in hemodialysis.

Interaction:Pharmacodynamic: Rimantadine reduces the effectiveness of antiepileptic drugs.
Pharmacokinetic: adsorbents, astringents and enveloping agents reduce the absorption of rimantadine. Paracetamol and acetylsalicylic acid reduce the maximum concentration of rimantadine by 11% and 10%, respectively. Cimetidine reduces the clearance of rimantadine by 18%.
Urinary acidifying agents (ammonium chloride, ascorbic acid, etc.) reduce the effectiveness of the action of rimantadine, due to the more rapid release of the latter kidneys.
Urinary alkalizing agents (acetazolamide, diacarb, sodium hydrogen carbonate and others) intensify the action of rimantadine, due to the decrease in its excretion by the kidneys.

Special instructions:Perhaps the emergence of drug-resistant viruses.
Prophylactic reception is effective at contacts with the sick (taking the drug is necessary at least for 10 days after contact), with the spread of infection in closed groups and at a high risk of disease during the flu epidemic.
Rimantadine is effective for preventing influenza after contact with a sick family member, but is less effective in preventive use in a family in which people with influenza A receive for preventive purposes rimantadine (probably associated with the transmission of drug-resistant viruses).
With the use of rimantadine, there may be an exacerbation of chronic comorbidities. In elderly patients with arterial hypertension, the risk of hemorrhagic stroke increases. With a history of epilepsy and anticonvulsant therapy, Rimantadine is at increased risk of developing seizures. In such cases Rimantadine apply in a dose of 100 mg / day simultaneously with anticonvulsant therapy.
With influenza caused by virus B, Rimantadine has an antitoxic effect.
In individuals with renal insufficiency Rimantadine can accumulate in toxic concentrations if the dose is not corrected in proportion to the level of creatinine clearance.
In elderly people, the dose should be reduced.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 50 mg.

Packaging:10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. 1, 2, 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.
For 30 tablets in cans of polymeric for storing medicines and vitamins or in polymer cans with the control of the first autopsy and a shock absorber. 1 bank together with the instruction for use is placed in a pack of cardboard.

Storage conditions:In a dry place, at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:5 years.
Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002997

Date of registration:18.05.2015

The owner of the registration certificate:NGO Farmvilar, OOO NGO Farmvilar, OOO Russia

Manufacturer: & nbsp

NGO Farmvilar, OOO Russia

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Rimantadine (Rimantadine)