Producer: CJSC Verteks Russia
Code of automatic telephone exchange: R03DX03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
The operating vezshchestvo: 80 mg of a fenspirid of a hydrochloride.
Excipients: коллидон SR (polyvinyl acetate of 80%, povidone of 19%, sodium lauryl sulfate of 0.8%, silicon dioxide of 0.2%) - 120 mg, hydrophosphate calcium a dihydrate - 95.5 mg, silicon dioxide colloid - 1.5 mg, magnesium stearate - 3 mg.
Structure of a film cover: a gipromelloza - 4.5 mg, talc - 1.764 mg, a hypro rod (hydroxypropyl cellulose) - 1.746 mg, titanium dioxide - 0.99 mg or the dry mix for a film covering containing a gipromelloza (50%), a hypro rod (hydroxypropyl cellulose) (19.4%), talc (19.6%), titanium dioxide (11%) - 0.99 mg.
Pharmacodynamics. Antiinflammatory and antibronkhokonstriktorny activity of a fenspirid is caused by reduction of products of a number of biologically active agents (cytokines, especially a factor of a necrosis of tumors α (ФНО-α), derivative arachidonic acid, free radicals) playing an important role in development of an inflammation and bronchospasm. The inhibition fenspiridy metabolism of arachidonic acid is exponentiated by its H1 - antihistaminic action since the histamine stimulates metabolism of arachidonic acid with formation of prostaglandins and leukotrienes. Fenspirid blocks α-adrenoceptors, which stimulation is followed by increase in secretion of bronchial glands. Thus, фенспирид reduces action of a number of factors which promote hypersecretion of pro-inflammatory factors, development of an inflammation and obstruction of bronchial tubes. Fenspirid also has spasmolytic effect.
Pharmacokinetics. After intake the maximum concentration of drug in a blood plasma (Cmax) is reached in 6 h. The elimination half-life of drug (T1/2) makes 12 h. It is removed preferential by kidneys.
Indications to use:
- bronchial asthma (as a part of complex therapy);
- the respiratory phenomena (cough, a voice osiplost, irritation in a throat) at measles, whooping cough and flu;
- at infectious diseases of the respiratory tracts which are followed by cough when a standard antibioticotherapia is shown.
Otitis and sinusitis of various etiology.
Route of administration and doses:
Inside. The adult – on 1 tablet 2-3 times a day. The maximum daily dose makes 240 mg. Duration of treatment is defined by the doctor.
Features of use:
Use at pregnancy and during breastfeeding. Administration of drug during pregnancy is not recommended. Therapy fenspiridy is not the basis for interruption of the occurred pregnancy.
Clinical data on fetotoksichesky action of a fenspirid or its ability to cause malformations at inclusion in time of pregnancy are absent.
It is not necessary to apply Eladon® during breastfeeding due to the lack of data on penetration of a fenspirid into breast milk.
Influence on ability of control of vehicles and mechanisms. Researches on drug Eladon®na influence studying ability to manage vehicles and work with mechanisms were not conducted. Patients have to be informed on possible development of drowsiness at administration of drug of Eladon®, especially at the beginning of therapy or at a combination to alcohol intake, and have to be careful at control of vehicles and when working, the psychomotor reactions demanding high speed.
From cardiovascular system: seldom – moderate tachycardia which expressiveness decreases at a drug dose decline.
From TsNS: seldom – drowsiness; unspecified frequency – dizziness.
Others: unspecified frequency – an adynamy, the increased fatigue.
Interaction with other medicines:
Special researches on interaction of a fenspirid with other medicines were not conducted.
Because of possible strengthening of sedation at reception of blockers histamine H1 receptors are not recommended use of the drug Eladon® in combination with the medicines possessing sedative action or together with alcohol.
Hypersensitivity to active agent and/or any of drug components, age up to 18 years.
At drug overdose (overdose cases at administration of drug in a dose more than 2320 mg are noted) it is necessary to ask for medical care immediately.
Treatment: gastric lavage, monitoring of an ECG. Maintenance of the vital functions of an organism.
Drug should be stored in protected from light, the place, unavailable to children, at a temperature not above 25 °C. Period of validity 2 years.
According to the recipe
On 15 tablets in a blister strip packaging, on 2 or 4 strip packagings in a cardboard pack.