Fespalen
Fespalen: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Fespalen
ATX code: R03DX03
Active ingredient: fenspiride (Fenspiride)
Manufacturer: Ozone LLC (Russia)
Description and photo update: 2019-10-07
Fespalen is an anti-inflammatory and anti-bronchoconstrictor agent.
Release form and composition
Dosage forms of Fespalena:
- film-coated tablets: round, biconvex, almost white or white; the cross section shows a core of almost white or white color and a film shell [10, 20 and 30 pcs. in blister contour packages, in a cardboard box 1, 2, 3, 4, 5, 6 or 10 packages; 10, 20, 30, 40, 50, 60 and 100 pcs. in jars sealed with pull-on lids with first opening control or with screw-on lids with “push-turn” system or with first opening control; a complete set of 2–3 cardboard packs is possible in a shipping container (group packing) made of cardboard];
- syrup: a clear orange liquid with a characteristic odor, in which during storage a precipitate can form, which disappears when shaken [100 and 150 ml each in polyethylene terephthalate or brown glass bottles, sealed with a plastic cap or a plastic screw cap with first opening control, in a cardboard box 1 bottle complete with a measuring spoon; it is possible to complete 2–3 cardboard packs in a shipping container (group packing) made of cardboard].
Each pack also contains instructions for the use of Fespalen.
Composition of 1 tablet:
- active ingredient: fenspiride hydrochloride - 80 mg;
- excipients: hypromellose, calcium hydrogen phosphate dihydrate, povidone-K25, magnesium stearate, colloidal silicon dioxide;
- film shell: macrogol-4000, magnesium stearate, titanium dioxide, hypromellose.
Composition of 1 ml of syrup:
- active ingredient: fenspiride hydrochloride - 2 mg;
- excipients: sodium saccharinate, sodium citrate, sorbitol, glycerol, propyl parahydroxybenzoate, potassium sorbate, methyl parahydroxybenzoate, citric acid monohydrate, purified water, sunset yellow dye, fruit flavor, honey flavor.
Pharmacological properties
Pharmacodynamics
Fenspiride hydrochloride is an anti-inflammatory and anti-bronchoconstrictor agent. Its therapeutic effects are due to the ability to reduce the production of a number of biologically active substances (cytokines, in particular tumor necrosis factor α, free radicals and derivatives of arachidonic acid), which play a key role in the development of the inflammatory process and bronchial obstruction.
The suppression of the metabolism of arachidonic acid by the drug is enhanced by its H1-antihistamine effect, since histamine stimulates the metabolism of arachidonic acid with the formation of leukotrienes and prostaglandins.
Fenspiride hydrochloride blocks α-adrenergic receptors, when stimulated, the secretion of the bronchial glands increases.
Thus, due to the properties of the active substance, Fespalen reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchospasm. Also, the drug has a myotropic spasmolytic effect.
Pharmacokinetics
After oral administration of fenspiride, hydrochloride is well absorbed from the gastrointestinal tract. The maximum plasma concentration (C max) reaches after 0.5-8 hours, an average of 2.5 hours.
The half-life (T 1/2) of the drug from the body is 12 hours. The substance is excreted: by the kidneys - 90%, through the intestines - no more than 10%.
Indications for use
Fespalen is used for the symptomatic treatment of the following diseases of the upper and lower respiratory tract:
- laryngitis;
- rhinopharyngitis;
- tracheobronchitis;
- respiratory symptoms (sore throat, hoarseness, cough) with flu, measles and whooping cough;
- infectious diseases of the respiratory tract, accompanied by a cough, when standard antibiotic therapy is indicated;
- bronchitis, including in patients with chronic respiratory failure;
- bronchial asthma (as part of complex therapy).
The drug is also prescribed for otitis media and sinusitis of various etiologies, including allergic (seasonal or permanent).
Contraindications
- children up to 2 years old and body weight up to 10 kg - for syrup;
- children and adolescents up to 18 years old - for tablets;
- pregnancy;
- lactation;
- hypersensitivity to any component of the drug.
Fespalen should be used with caution in patients receiving sedatives.
Fespalen, instructions for use: method and dosage
Fespalen is indicated for oral administration.
In tablets, the drug is prescribed for adults 1 pc. 2-3 times a day. The maximum allowable daily dose is 240 mg (3 tablets).
Fespalene syrup should be taken before meals, the bottle must be shaken beforehand.
Recommended daily doses of the drug in the form of a syrup (in several steps):
- children 2-16 years old weighing more than 10 kg - 4 mg / kg, or 30-60 ml (2-4 tablespoons *);
- adolescents over 16 years old and adults - 45–90 ml (3–6 tablespoons).
* content of fenspiride hydrochloride in 1 tablespoon - 30 mg
The duration of treatment is determined by the attending physician, depending on the clinical situation.
Side effects
The side effects described below are classified as follows: often - from> 1/100 to 1/10000 to <1/1000, unspecified frequency - based on the available data, it is not possible to calculate the incidence of undesirable effects:
- from the digestive system: often - pain in the epigastric region, nausea, gastrointestinal disorders; unspecified frequency - diarrhea, vomiting;
- from the central nervous system: rarely - drowsiness; unspecified frequency - dizziness;
- on the part of the cardiovascular system: rarely - moderate tachycardia (with a decrease in the dose of Fespalena, its severity decreases); unspecified frequency - a feeling of palpitations, a decrease in blood pressure;
- on the part of the skin and subcutaneous fat: rarely - urticaria, rash, erythema, fixed erythema pigmentosa, angioedema; unspecified frequency - itching of the skin, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- others: unknown frequency - increased fatigue, asthenia.
Overdose
The most common symptoms of an overdose (cases of taking fenspiride in a dose exceeding 2320 mg are known) are nausea, vomiting, agitation or drowsiness, sinus tachycardia.
In case of using an excessive dose of Fespalena, an urgent need to seek medical help. The first measure of help is gastric lavage. Further treatment is symptomatic, including the maintenance of vital body functions. It is required to monitor the electrocardiogram.
special instructions
Fespalen is not a substitute for antibiotic therapy. Taking it is not a reason to postpone the appointment of antibiotics.
Influence on the ability to drive vehicles and complex mechanisms
The effect of fenspiride on human cognitive function has not been studied. Patients should be warned that Fespalen may cause drowsiness, especially at the beginning of treatment and when drinking alcohol. It is recommended to be careful when driving vehicles and performing activities that require the speed of psychomotor reactions.
Application during pregnancy and lactation
Fespalen is not recommended for use by pregnant women. If pregnancy occurs during the period of therapy, the drug should be canceled; termination of pregnancy is not required.
There is no information on the excretion of fenspiride in mother's milk. The drug should not be used during lactation.
Pediatric use
In the form of syrup, Fespalen is contraindicated in children under 2 years of age, in the form of film-coated tablets - up to 18 years.
With impaired renal function
Information not provided by the manufacturer.
For violations of liver function
Information not provided by the manufacturer.
Use in the elderly
There is no data on the need to adjust the dose of Fespalena for elderly patients.
Drug interactions
Special studies on the interaction of fenspiride with other drugs / agents have not been conducted.
Fespalene is not recommended to be taken simultaneously with ethanol and in combination with drugs that have a sedative effect, since the sedative effect may increase.
Analogs
Fespalena's analogues are Velispal, Codetim, Montelukast, Siresp, Pharmaspal, Fenspirid, Eladon, Epistat, Erispirus.
Terms and conditions of storage
Store in a place protected from the sun, out of reach of children, at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Fespalena
Patients leave mostly positive reviews about Fespalene. Most of them are satisfied with the effect of the drug and note that the course of treatment helps to quickly get rid of even the most severe cough. Additional advantages indicate the absence of side reactions and an affordable cost, from the disadvantages - prescription sales.
In rare negative reports, there are complaints that Fespalen does not have the claimed therapeutic effect.
Price for Fespalen in pharmacies
The cost of a 2 mg / ml syrup is approximately 163 rubles. for 1 bottle of 150 ml. The price of Fespalena in the form of 80 mg film-coated tablets, 30 pcs. in a package averages 280 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
