Description
release form
Syrup for children 2 mg / ml.
100 ml or 200 ml in dark glass bottles, sealed with polypropylene caps with primary opening control and protection against opening by children.
One bottle with instructions for use and a measuring spoon are placed in a pack of cardboard.
Pharmacological action of
Pharmacodynamics of
Rimantadine – an antiviral agent derived from adamantane is active against various strains of influenza A. Being 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 membrane with the endosome membrane, thus preventing the transmission 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 intestines. Absorption is slow. Communication with plasma proteins – about 40%. Distribution volume: adults – 17-25 l / kg, children – 289 l / kg. The concentration in nasal secretion is 50% higher than plasma. The maximum concentration of rimantadine in blood plasma (Cmax) when taking 100 mg once a day – 181 ng / ml, 100 mg 2 times a day – 416 ng / ml.
Metabolized in the liver. The half-life (T 1/2) – 24-36 hours is excreted by the kidneys 15% – unchanged, 20% – in the form of hydroxyl metabolites.
In chronic renal failure, T1 / 2 increases by 2 times. In persons with renal failure and in the elderly, it can accumulate in toxic concentrations if the dose is not corrected in proportion to a decrease in creatinine clearance.
Indications
Prevention and early treatment of influenza A in children older than 1 year.
Prophylaxis with rimantadine can be effective in contact with patients at home, with the spread of infection in closed groups, and at high risk of the disease during an influenza epidemic.
Contraindications
Acute liver disease
acute and chronic kidney disease
thyrotoxicosis
pregnancy and lactation
children under 1 year
increased sensitivity to rimantadine and malignant sulphosis
Precautions
Epilepsy (including history), severe chronic renal failure, liver failure, diabetes mellitus.
Due to the presence of sorbitol in the composition should be taken with caution in case of vomiting, pain and discomfort in the abdomen, diarrhea.
Use during pregnancy and lactation
Use of the drug is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.
Special instructions
The use of rimantadine within 2-3 days before and 6-7 hours after the onset of clinical manifestations of type A influenza reduces the severity of disease symptoms and the degree of serological reaction. Some therapeutic effect may also occur, if rimantadine is prescribed within 18 hours after the onset of the first symptoms of influenza.
During use, exacerbation of chronic concomitant diseases is possible.
In patients with epilepsy with rimantadine, the risk of developing an epileptic seizure increases. 15 ml of syrup corresponds to 1 bread unit (XE), which should be considered when prescribing the drug to patients with diabetes.
Possible drug-resistant viruses.
Sorbitol can cause abdominal discomfort and a laxative effect. In the case of the development of such effects during treatment, the drug should be discontinued and consult a doctor.
Due to the increased risk of dyspeptic symptoms, it is not recommended to take it simultaneously with foods containing a significant amount of sorbitol (prunes, etc.).
Effect on the ability to drive vehicles and mechanisms
Given the likelihood of side effects from the central nervous system, caution should be exercised when driving vehicles and mechanisms.
Composition
Active ingredient: rimantadine hydrochloride – 2.0 mg
Excipients: sorbitol (liquid sorbitol) – 514.3 mg, maltitol (liquid maltitol) – 514, 3 mg, sodium carmellose – 3.64 mg, methyl parahydroxybenzoate – 1.15 mg, strawberry flavor – 0.63 mg, purified water – up to 1 ml.
Dosage and administration
Treatment regimen: Take orally (after eating) with water, according to the following scheme: for children from 1 year to 3 years old – on the first day 10 ml (2 teaspoons) of syrup (20 mg) 3 once 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 per day (daily dose – 20 mg) .
For children from 3 to 7 years old – on the first day – 15 ml (3 teaspoons) of syrup (30 mg) j 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 per day (daily dose – 30 mg).
For children from 7 to 10 years old, 25 ml (5 teaspoons) of syrup (50 mg) 2 times a day for 5 days (daily dose is 100 mg).
For children from 11 to 14 years old, 25 ml (5 teaspoons) of syrup (50 mg) 3 times a day for 5 days (daily dose is 150 mg).
Prophylactic regimen: For prophylaxis use: for children from 1 year to 3 years old – 10 ml (2 teaspoons) of syrup (20 mg) once a day,
for children from 3 to 7 years old – 15 ml (3 teaspoonfuls tablespoons) of syrup (30 mg) once a day,
for children over 7 years old – 25 ml (5 teaspoons) of syrup (50 mg) 1 time per day for 10-15 days.
Attention! The daily dose of rimantadine should not exceed 5 mg per kg of body weight.
Side effects of
From the cardiovascular system: tachycardia, heart failure, heart block, sensation of a heartbeat, arterial hypertension, cerebrovascular accident, loss of consciousness.
From the side of the nervous system: insomnia, dizziness, headache, irritability, fatigue, impaired attention, movement disorders, drowsiness, depressed mood, euphoria, hyperkinesia, tremors, hallucinations, confusion, convulsions.
From the sensory organs: tinnitus, change or loss of smell.
From the respiratory system: shortness of breath, bronchospasm, cough.
From the gastrointestinal tract: nausea, vomiting, loss of appetite, dry oral mucosa, abdominal pain, diarrhea, dyspepsia.
From the rut and subcutaneous tissue: rash.
Other: fatigue.
Drug Interactions
Pharmacodynamic: 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 concurrently used drugs.
Due to the increased risk of dyspeptic symptoms, simultaneous administration with other medicines containing sorbitol is not recommended.
Overdose of
In some cases, when the recommended dose is exceeded, tearing of the eyes and pain in the eyes, frequent urination, fever, constipation, sweating, inflammation of the oral mucosa, dry skin are observed.
Treatment: gastric lavage, symptomatic therapy: measures to maintain vital functions. Rimantadine is partially excreted during hemodialysis.
Storage conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Expiration
2 years.
Active ingredient
Rimantadine
Terms leave through pharmacies
In retseptu
lekarstvennaja form
syrup
