Rimantadine tablets 50mg, No. 20

Early treatment and prevention of influenza A in adults and children over 7 years old.

Rimantadine is taken orally (after meals) with water.
Treatment for influenza should be started within 24 to 48 hours after the onset of symptoms. Adults on the first day, 100 mg 3 times a day; on 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, it is possible to use the drug once in a dose of 300 mg.
Children aged 7 to 10 years, 50 mg 2 times a day; from 10 to 14 years old - 50 mg 3 times a day; over 14 years old - 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 over 7 years of age, 50 mg once a day for up to 15 days, depending on the epidemiological situation.
For the treatment and prevention of influenza in severe hepatic insufficiency of epilepsy in elderly patients, 100 mg 1 time per day.

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

- hypersensitivity to the components of the drug rimantadine;
- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- acute liver disease;
- acute and chronic kidney disease;
- thyrotoxicosis;
- pregnancy and lactation;
- children up to age 7 years.

Carefully:

use in case of arterial hypertension, epilepsy (including history), atherosclerosis of cerebral vessels in case of liver failure in elderly patients, diseases of the gastrointestinal tract.

Trade name of the drug

Rimantadin

International non-proprietary name

Rimantadin

Dosage form

Pills

Composition

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

Description

The tablets are white or almost white, round, flat, with a line on one side and chamfers on both sides.

Pharmacotherapeutic group

Antiviral agent

ATX code

J05AC

Pharmacodynamics:

Rimantadine is active against various strains of influenza A. Being a weak base, rimantadine acts by increasing the pH of endosomes with membrane vacuoles that surround viral particles after they enter the cell.
Prevention of 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 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 is almost completely absorbed in the intestine.
Absorption is slow. The connection with plasma proteins is about 40%. 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) when taking 100 mg 1 time per day is 181 ng / ml, 100 mg 2 times a day - 416 ng / ml.
It is metabolized in the liver. Half-life (T1 / 2) - 24-36 hours; excreted by the kidneys 15% - unchanged 75-85% - in the form of metabolites.
In chronic renal failure, T1 / 2 increases by 2 times. In persons with renal insufficiency and in the elderly, 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 over 7 years old.

Contraindications:

- hypersensitivity to the components of the drug rimantadine;
- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
- acute liver disease;
- acute and chronic kidney disease;
- thyrotoxicosis;
- pregnancy and lactation;
- children up to age 7 years.

Carefully:

use in case of arterial hypertension, epilepsy (including history), atherosclerosis of cerebral vessels in case of liver failure in elderly patients, diseases of the gastrointestinal tract.

Pregnancy and lactation:

The use of rimantadine during pregnancy and during breastfeeding is contraindicated.

Method of administration and dosage:

Rimantadine is taken orally (after meals) with water.
Treatment for influenza should be started within 24 to 48 hours after the onset of symptoms. Adults on the first day, 100 mg 3 times a day; on 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, it is possible to use the drug once in a dose of 300 mg.
Children aged 7 to 10 years, 50 mg 2 times a day; from 10 to 14 years old - 50 mg 3 times a day; over 14 years old - 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 over 7 years of age, 50 mg once a day for up to 15 days, depending on the epidemiological situation.
For the treatment and prevention of influenza in severe hepatic insufficiency of epilepsy in elderly patients, 100 mg 1 time per day.

Side effects:

From the nervous system: headache dizziness insomnia nervousness disturbance in concentration of attention drowsiness anxiety increased excitability fatigue ataxia depression euphoria hyperkinesis tremor hallucinations confusion of consciousness convulsions.
From the digestive system: epigastric pain flatulence dryness of the oral mucosa anorexia (lack of appetite) nausea vomiting diarrhea dyspepsia.
From the side of the cardiovascular system: pallor of the skin, palpitations, arterial hypertension, cerebrovascular disorder, heart block, tachycardia, syncope.
From the senses: ringing in the ears; change in taste; perversion of the sense of smell.
From the respiratory system:shortness of breath bronchospasm cough.
Allergic reactions: skin rash itching urticaria.
Others: asthenia, hyperbilirubinemia.

Overdose:

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

Interaction:

Rimantadine reduces the effectiveness of antiepileptic drugs.
Adsorbents, astringents and coating agents, reduce the absorption of rimantadine. Alkalizing agents for urine (acetazolamide sodium bicarbonate) 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 by increasing its excretion by the kidneys.
Paracetamol and ascorbic acid reduce the maximum plasma concentration of rimantadine by 11%.
Cimetidine reduces the clearance of rimantadine by 18%.

Special instructions:

With the use of rimantadine, an exacerbation of chronic concomitant diseases is possible. In elderly patients with arterial hypertension, the risk of developing hemorrhagic stroke increases. With indications of a history of epilepsy and ongoing anticonvulsant therapy while using rimantadine, the risk of developing an epileptic seizure increases. In such cases, rimantadine is used at a dose of 100 mg per day simultaneously with anticonvulsant therapy. Prophylactic reception is effective in contact with patients with the spread of infection in closed groups and with a high risk of illness during an influenza epidemic.
The emergence of drug-resistant viruses is possible.

Impact on the ability to drive vehicles. Wed and fur .:

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reaction.

Release form / dosage:

Tablets 50 mg.

Packaging:

On 10 20 30 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.
10 20 30 40 50 60 70 80 90 or 100 tablets in polymer jars for medicines.
One can or 1 2 3 4 5 6 8 or 10 blisters together with instructions for use are placed in a cardboard package (pack).

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Vacation conditions

Without recipe

Manufacturer

Limited Liability Company 'Ozon' (LLC 'Ozon'), 445351, Samara region, Zhigulevsk, st. Gidrostroiteley, 6, Russia