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

Composition:Composition per 1 tablet:
Active substance:
rimantadine hydrochloride - 50.0 mg;
Excipients:
lactose monohydrate (sugar milk) - 98.4 mg;
cellulose microcrystalline - 28.0 mg;
croscarmellose sodium - 5.7 mg;
povidone-K25 - 6.0 mg;
magnesium stearate - 1.9 mg.

Description:Tablets are white or almost white, round, flat, with a risk on one side and chamfers on both sides.

Pharmacotherapeutic group:An antiviral agent.

ATX: & nbsp

J.05.A.C Cyclic amines

J.05.A.C.02 Rimantadine

Pharmacodynamics:Rimantadine is active against various strains of influenza A virus. As a weak basis, rimantadine acts by increasing the pH of the endosome, which have a membrane of vacuoles that surround the viral particles after they penetrate 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.

Pharmacokinetics:After oral administration rimantadine almost completely absorbed in the intestine.
Absorption is slow. The connection with plasma proteins is about 40%. The volume of distribution: adults - 17-25 l / kg, children - 289 l / kg. Concentration in nasal secretion is 50% higher than plasma concentration.The maximum concentration of rimantadine in blood plasma (Cmax) with the intake of 100 mg once a day - 181 ng / ml, 100 mg twice a day - 416 ng / ml.
Metabolised in the liver. The half-life (T1 / 2) is 24-36 hours; is excreted by the kidneys 15% - unchanged, 75-85% - in the form of metabolites.
In chronic renal failure, T1 / 2 increases by 2 times. In individuals with kidney failure and in elderly people, it can accumulate in toxic concentrations if the dose is not adjusted in proportion to the decrease in creatinine clearance.

Indications:Early treatment and prevention of influenza A in adults and children older than 7 years.

Contraindications:- hypersensitivity to rimantadine, the components of the drug;
- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
acute liver disease;
- Acute and chronic kidney disease;
- thyrotoxicosis;
- Pregnancy and lactation;
- Children under 7 years.

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

Pregnancy and lactation:The use of rimantadine in pregnancy and during breastfeeding is contraindicated.

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 on the first day of 100 mg 3 times a day; in the second and third days of 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, 50 mg 2 times a day; from 10 to 14 years - 50 mg 3 times a day; over 14 years - doses for adults. Course 5 days.
For the prevention of influenza: in 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 and prevention of influenza in severe hepatic insufficiency, epilepsy, elderly patients 100 mg 1 time per day.

Side effects:From the nervous system: headache, dizziness, insomnia, nervousness, impaired concentration, drowsiness, anxiety, increased excitability, fatigue, ataxia, depression, euphoria, hyperkinesia, tremor, hallucinations, confusion, convulsions.
From the digestive system: epigastric pain, flatulence, dryness of the oral mucosa, anorexia (lack of appetite), nausea, vomiting, diarrhea, indigestion.
From the cardiovascular system: pallor of the skin, palpitation, arterial hypertension, cerebrovascular disorder, heart block, tachycardia, fainting.
From the sense organs: ringing in the ears, a change in taste, a perversion of the sense of smell.
From the respiratory system: shortness of breath, bronchospasm, cough.
Allergic reactions: skin rash, itching, hives.
Other: asthenia, hyperbilirubinemia.

Overdose:Symptoms: agitation, hallucinations, arrhythmia, stomach pain, irritability, insomnia, tremor, convulsions.
Treatment: gastric lavage, symptomatic therapy: measures to maintain vital functions. Rimantadine partially excreted in hemodialysis.

Interaction:Rimantadine reduces the effectiveness of antiepileptic drugs.
Adsorbents, astringents and enveloping agents reduce the absorption of rimantadine. Urine alkaline agents (acetazolamide, sodium hydrogen carbonate) increase the effectiveness of rimantadine due to a decrease in its excretion by the kidneys.Urine acidifying agents (including ascorbic acid) reduce the effectiveness of rimantadine due to an increase in its excretion by the kidneys.
Paracetamol and ascorbic acid reduce the maximum concentration of rimantadine in blood plasma by 11%.
Cimetidine reduces the clearance of rimantadine by 18%.

Special instructions:With the use of rimantadine, an exacerbation of chronic comorbidity may occur. In elderly patients with hypertension, the risk of hemorrhagic stroke increases. With a history of epilepsy and ongoing anticonvulsant therapy with rimantadine, the risk of epileptic seizures increases. In such cases rimantadine apply in a dose of 100 mg per day simultaneously with anticonvulsant therapy. Prophylactic reception is effective at contacts with the sick, with the spread of infection in closed collectives and at a high risk of the disease during the flu epidemic.
Perhaps the emergence of drug-resistant viruses.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and taking other potentially hazardousActivities that require increased concentration of attention and speed of the psychomotor reaction.

Form release / dosage:Tablets 50 mg.

Packaging:For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
By 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets in cans of polymeric for medicines.
One jar or 1, 2, 3, 4, 5, 6, 8 or 10 contour squares, together with the instructions for use, are placed in a cardboard package (bundle).

Storage conditions:In the dark place at a temperature of no higher than 25 0C.
Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002611

Date of registration:04.09.2014

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Rimantadine (Rimantadine)