Rimantadine Kids syrup 2mg/ml, 200ml

Composition

Active ingredient:

rimantadine hydrochloride – 2.0 mg

Auxiliary substances:

sorbitol (sorbitol liquid) – 514,3 mg

maltitol (maltitol liquid) – 514,3 mg,

carmellose sodium – 3,64 mg,

methyl parahydroxybenzoate – 1,15 mg,

strawberry flavor is 0.63 mg,

purified water -up to 1 ml.

Pharmacological action of

Pharmacodynamically – antiviral agent, a derivative of adamantane; active against different strains of influenza virus A. Being a weak base, rimantadine acts by increasing the pH endosome with membrane vacuoles that surround the viral particles after their penetration into the cell. Preventing acidification in these vacuoles blocks the fusion of the viral envelope with the endosome membrane, thus preventing the transfer of viral genetic material to the cell cytoplasm. Rimantadine also inhibits the release of viral particles from the cell, i. e. interrupts the transcription of the viral genome. Pharmacokineticsafter oral use, rimantadine is almost completely absorbed in the intestine. Absorption is slow. Binding to plasma proteins is about 40%. Volume of distribution: adults – 17-25 l/kg, children – 289 l/kg. The concentration in the nasal secretions is 50% higher than the plasma one. The maximum concentration of rimantadine in blood plasma (Cmax) when taking 100 mg once a day is 181 ng / ml,100 mg twice a day is 416 ng/ml. It is metabolized in the liver. The half-life (T 1/2) is 24-36 hours; 15% is excreted unchanged by the kidneys,20% – in the form of hydroxyl metabolites. In chronic renal failure, T 1/2 increases by 2 times. In patients with renal insufficiency and in the elderly, toxic concentrations may accumulate if the dose is not corrected in proportion to the decrease in creatinine clearance.

Indications

Prevention and early treatment of influenza A in children over 1 year of age.

Rimantadine prophylaxis can be effective in contact with people who are sick at home, when the infection spreads in closed groups, and when there is a high risk of developing the disease during an influenza epidemic.

Use during pregnancy and lactation

The use of the drug is contraindicated during pregnancy. If necessary, use during lactation should stop breastfeeding.

Contraindications

• Acute liver diseases;
• acute and chronic kidney diseases;
• thyrotoxicosis;
• pregnancy and lactation;
• children under 1 year of age;
• hypersensitivity to rimantadine and its components
• ;sucrose/isomaltase deficiency;
• glucose-galactose malabsorption;
• fructose intolerance.

With caution

Epilepsy (including in the anamnesis), severe chronic renal failure, liver failure, diabetes mellitus.

Due to the presence of sorbitol in the composition, it should be taken with caution in case of vomiting, abdominal pain and discomfort, diarrhea.

Side effects

From the cardiovascular system: tachycardia, heart failure, heart block, palpitation sensation, arterial hypertension, impaired cerebral circulation, loss of consciousness. From the nervous system: insomnia, dizziness, headache, irritability, fatigue, impaired concentration, motor disorders, drowsiness, depressed mood, euphoria, hyperkinesia, tremor, hallucinations, confusion, convulsions. From the side of the senses: tinnitus, change or loss of the sense 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, dyspepsia. From the rut and subcutaneous tissue: rash. Other: fatigue.

Pharmacodynamic interaction: rimantadine reduces the effectiveness of antiepileptic drugs. Pharmacokinetic: adsorbents, astringents and enveloping agents reduce the absorption of rimantadine. Urine acidifying agents (acetazolamide, sodium bicarbonate, etc. ) increase the concentration of rimantadine. Paracetamol and ascorbic acid reduce the maximum concentration of rimantadine in blood plasma by 11%. Cimetidine reduces rimantadine clearance by 18%. The sorbitol contained in the preparation may affect the bioavailability of concomitantly used medications. Due to the increased risk of dyspeptic symptoms, concomitant use with other medications containing sorbitol is not recommended.

How to take, course of use and dosage

Treatment scheme: Take orally (after meals), washed down with water, according to the following scheme: children from 1 year to 3 years-on the first day 10 ml (2 teaspoons) of syrup (20 mg) 3 times a day (daily dose – 60 mg); 2 and 3 days – 10 ml 2 times a day (daily dose – 40 mg),4 day – 5 day – 10 ml 1 time a day (daily dose – 20 mg). Children from 3 to 7 years – on the first day-15 ml (3 teaspoons) of syrup (30 mg) 2 times a day (daily dose-90 mg); 2 and 3 days – 3 teaspoons 2 times a day (daily dose-60 mg),4 days-5 days-3 teaspoons 1 time a day (daily dose-30 mg). Children from 7 to 10 years of age: 25 ml (5 teaspoons) of syrup (50 mg) 2 times a day for 5 days (daily dose-100 mg). Children from 11 to 14 years of age: 25 ml (5 teaspoons) of syrup (50 mg) 3 times a day for 5 days (daily dose-150 mg). Preventive scheme: For prevention use: children from 1 to 3 years – 10 ml (2 teaspoons) of syrup (20 mg) 1 time a day, children from 3 to 7 years-15 ml (3 teaspoons) of syrup (30 mg) 1 time a day, children over 7 years – 25 ml (5 teaspoons) of syrup (50 mg) 1 time a day for 10-15 days. Attention! The daily dose of rimantadine should not exceed 5 mg per kg of body weight.

Overdose

In some cases, if the recommended dose is exceeded, the following symptoms are observed: eye watering and eye pain, frequent urination, fever, constipation, sweating, inflammation of the oral mucosa, dry skin.

Treatment: gastric lavage, symptomatic therapy: measures to maintain vital functions. Rimantadine is partially eliminated by hemodialysis.

Special instructions

The use of rimantadine for 2-3 days before and 6-7 hours after the onset of clinical manifestations of influenza type A reduces the severity of symptoms of the disease and the degree of serological response. Some therapeutic effects may also occur if rimantadine is prescribed within 18 hours of the onset of the first flu symptoms. When used, it is possible to exacerbate chronic concomitant diseases. In patients with epilepsy, rimantadine increases the risk of developing an epileptic seizure. 15 ml of syrup corresponds to 1 bread unit (XE), which should be taken into account when prescribing the drug to patients with diabetes mellitus. Viruses that are resistant to the drug may appear. Sorbitol can cause abdominal discomfort and have a laxative effect. If such effects develop during treatment, the drug should be discontinued and a doctor should be consulted. Due to the increased risk of dyspeptic symptoms, concomitant use with foods containing significant amounts of sorbitol (prunes, etc. ) is not recommended. Effects on the ability to drive vehicles and mechanicsac Counting the likelihood of side effects from the central nervous system, care should be taken when driving vehicles, mechanisms.

Form of production

Syrup for children 2 mg / ml.

100 ml or 200 ml in dark glass bottles, sealed with polypropylene lids with primary control of opening and protection against opening by children.

One bottle with instructions for use and a measuring spoon is placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Rimantadine

Conditions of release from pharmacies

By prescription

Dosage form

syrup