Fenspiride

Brand Vertex

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Clinical Pharmacology

Pharmacological action - bronchodilatory, anti-inflammatory.

Pharmacodynamics

Anti-inflammatory and anti-bronchoconstrictor activity of fenspiride is due to a decrease in the production of a number of biologically active substances (cytokines, especially TNF-α, arachidonic acid derivatives, free radicals), which play an important role in the development of inflammation and bronchospasm.

H has₁- an antihistamine effect, reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction. Fenspirid also has a spasmolytic effect.

Pharmacokinetics

After ingestion T_max drug in blood plasma - 6 h. T_1/2 The drug is 12 hours. Excreted mainly by the kidneys.

Indications

Diseases of the upper and lower respiratory tract:

rhinopharyngitis and laryngitis;
tracheobronchitis;
bronchitis (with or without chronic respiratory failure);
bronchial asthma (as part of complex therapy);
respiratory symptoms (cough, hoarseness, sore throat) for measles, whooping cough and flu;
infectious diseases of the respiratory tract, accompanied by cough, when shown standard antibiotic therapy;
otitis media and sinusitis of various etiologies.

Composition

pills of prolonged action, film-coated white or almost white color, round, biconvex; on the cross-section - the core is white or almost white.

	1 tab.
fenspiride hydrochloride	80 mg

Excipients: Kollidon SR (polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%) - 120 mg, calcium hydrogen phosphate dihydrate - 95.5 mg, silicon colloid dioxide - 1.5 mg, magnesium stearate - 3 mg.

The composition of the film coating: hypromellose - 4.5 mg, talc - 1.764 mg, hyprolosis (hydroxypropylcellulose) - 1.746 mg, titanium dioxide - 0.99 mg or dry mixture for film coating containing hypromellose (50%), hyprolose (hydroxypropylcellulose) (19.4%), talc (19.6%), titanium dioxide (11%) - 0.99 mg.

Fenspiride is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
ELADON	Vertex	Russia	pills
Syresp®	Medana Pharma	Poland	syrup

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Dosage and Administration

For oral use

Adults: 1 tab. 2-3 times a day. The maximum daily dose is 240 mg. The duration of treatment is determined by the doctor.

Adverse reactions

The frequency of side effects that may occur during therapy is given in the following grades: very often - ≥1 / 10 (≥10%); often from ≥1 / 100 to

From the CCC: rarely - moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug.

From the digestive system: often - gastrointestinal disorders, nausea, epigastric pain; Unspecified frequency - diarrhea, vomiting.

From the side of the central nervous system: rarely - drowsiness; Unspecified frequency - dizziness.

On the part of the skin: rarely - erythema, rash, urticaria, angioedema, fixed erythema pigmentosa; Unassigned frequency - pruritus.

Other: Unknown frequency - asthenia, increased fatigue.

Contraindications

Hypersensitivity to the active substance and / or any of the components of the drug;
age up to 18 years.

Drug interactions

Special studies on the interaction of fenspiride with other drugs have been conducted.

Because of the possible increase in sedation when taking histamine H blockers₁-receptors do not recommend the use of the drug Eladon^® in combination with drugs that have a sedative effect, or in conjunction with alcohol.

Pregnancy and Lactation

Taking the drug during pregnancy is not recommended.

Fenspiride therapy is not a reason to terminate the onset of pregnancy. There are no clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations when taken during pregnancy.

Do not use Eladon^® during the breastfeeding period due to the lack of data on the penetration of fenspiride into breast milk.

Special instructions

Impact on the ability to drive and work with mechanisms. Studies on the effect of the drug Eladon^® the ability to drive vehicles and work with mechanisms were not carried out. Patients should be aware of the possible development of drowsiness while taking Eladon^®, especially at the beginning of therapy or in combination with alcohol intake, and should be careful when driving vehicles and performing work that requires a high speed of psychomotor reactions.

Overdosage

In case of overdose of the drug (there are cases of overdose when taking the drug in a dose of more than 2320 mg) should immediately seek medical help.

Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment: gastric lavage, ECG monitoring. Maintaining vital body functions.

Brand name: ELADON
Active ingredient: Fenspirid
Dosage form: Pills: round, biconvex, film-coated white or almost white. In cross section, the core is white or almost white.
Manufacturer: Vertex
Country of Origin: Russia