Composition, form of production and packaging
? Tablets are white in color, flat-cylindrical.
1 tab.
rimantadine hydrochloride 50 mg
[PRING] lactose (sugar milk) - 60 mg, potato starch - 37 mg, calcium stearate - 1.5 mg, talc - 1.5 mg.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
20 pcs. - packings of cellular contour (1) - packs cardboard.
20 pcs. - polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Rimantadine is active against various strains of influenza A virus. As a weak base, rimantadine acts by increasing the pH of endosomes that have a membrane of vacuoles that surround 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.
PHARMACOKINETICS
After ingestion, rimantadine is almost completely absorbed into the intestine. Absorption is slow. The connection with plasma proteins is about 40%. V d : adults - 17-25 l / kg, children - 289 l. Concentration in nasal secretion is 50% higher than in plasma. C max active substance in the blood plasma at a dose of 100 mg 1 time / day - 181 ng / ml, with 100 mg 2 times / day - 416 ng / ml. Metabolised in the liver. T 1/2 - 24-36 h; 75-85% of the accepted dose is excreted by the kidneys mainly in the form of metabolites, 15% - in unchanged form.
In chronic renal failure T 1/2 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 QC.
INDICATIONS
- prevention and early treatment of influenza A in adults and children older than 7 years.
DOSING MODE
Inside after eating, squeezed with water. Treatment of influenza should be started within 24-48 hours after the onset of symptoms of the disease.
Adults the first day is prescribed 100 mg 3 times / day; in the second and third days of 100 mg 2 times / day; on the fourth and fifth day of 100 mg 1 time / day. On the first day of the disease, 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; from 11 to 14 years - 50 mg 3 times / day. Older than 14 years - doses for adults.
Take for 5 days.
To prevent influenza, adults are prescribed 50 mg 1 time / day for up to 30 days. Children older than 7 years - 50 mg 1 time / day for up to 15 days.
SIDE EFFECT
On the part of the digestive system: dry mouth, nausea, vomiting, loss of appetite, epigastric pain, flatulence.
From the side of the central nervous system: headache, dizziness, insomnia, neurological reactions, impaired concentration, drowsiness, anxiety, increased excitability, fatigue.
Other: hyperbilirubinemia, allergic reactions (skin rash, itching, urticaria).
CONTRAINDICATIONS
acute liver disease;
- Acute and chronic kidney disease;
- thyrotoxicosis;
- hypersensitivity to rimantadine;
- pregnancy and lactation;
- children under 7 years;
- with lactase deficiency, lactose intolerance, lactose / isomaltose malabsorption syndrome (since the formulation contains lactose).
With caution: with arterial hypertension, atherosclerosis of cerebral vessels, liver failure, epilepsy, gastrointestinal diseases.
APPLICATION FOR FUNCTIONS OF THE LIVER
It is forbidden to use the drug in patients with acute and chronic kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
It is forbidden to use the drug for patients with acute liver disease.
Use with caution in liver failure.
APPLICATION FOR CHILDREN
It is forbidden to use the drug for children under 7 years.
Children aged 7 to 10 years are prescribed 50 mg twice a day; from 11 to 14 years - 50 mg 3 times / day. Older than 14 years - doses for adults.
For the prevention of influenza , children older than 7 years - 50 mg 1 time / day for up to 15 days.
APPLICATION IN ELDERLY PATIENTS
In elderly people, the drug may accumulate in toxic concentrations if the dose is not adjusted in proportion to the decrease in QC.
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 against rimantadine, the risk of epileptic seizure increases. In such cases, rimantadine is used at a dose of 100 mg / day simultaneously with anticonvulsant therapy.
With influenza caused by virus B, rimantadine exerts an antitoxic effect.
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.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: agitation, hallucinations, arrhythmia.
Treatment: gastric lavage, symptomatic therapy: measures to maintain vital functions. Rimantadine is partially excreted in hemodialysis.
DRUG INTERACTION
Rimantadine reduces the effectiveness of antiepileptic drugs.
Paracetamol and ascorbic acid reduce the maximum concentration of rimantadine in blood plasma by 11%.
Cimetidine reduces the clearance of rimantadine by 18%.
Adsorbents, astringents and enveloping agents reduce the absorption of rimantadine.
Urine alkalizing agents (acetazolamide, sodium bicarbonate, etc.) enhance the effectiveness of rimantadine due to a decrease in its excretion by the kidneys.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light and out of reach of children at a temperature of no higher than 25 В° C.
Shelf life - 5 years.
