Composition
Active ingredient: Â
sechifenadine hydrochloride dihydrate 50 mg;
Auxiliary substances:
lactose monohydrate — 302 mg;
MCC-20 mg;
corn starch-20 mg;
silicon dioxide-2 mg;
magnesium stearate-6 mg
Pharmacological action
Histafen is an anti-allergic drug.
Pharmacodynamics
Sechifenadine is a blocker ofH1-histamine receptors, and also moderately blocks serotonin 5-HT1receptors, thus weakening the action of allergy mediators histamine and serotonin. Histamine causes clinical manifestations of allergic inflammation: edema (increased capillary permeability), skin hyperemia (vasodilation), itching and pain. The peculiarity of sechifenadine is that it has an antihistamine effect, not only blocking histamineH1receptors, but also reducing the content of histamine in tissues by accelerating its destruction by diamine oxidase.
With allergic diseases, the content of serotonin in the blood also increases. Serotonin increases Blood pressure, causes bronchospasm, increases capillary permeability, enhances the action of inflammatory mediators-histamine, bradykinin, PG. Sehifenadine prevents or reduces the spasmogenic effect of histamine and serotonin on the smooth muscles of the bronchi, intestines, and blood vessels; impaired capillary permeability and the development of edema.
Sehifenadine has a pronounced antipruritic and antiexudative effect of a long-lasting nature.
It affects the immunological reactivity of the body, reducing the number of B-lymphocytes in the spleen, bone marrow, and lymph nodes, and also reduces the increased concentration of Id Classes A and G.
Slightly penetrates through the BBB, which explains the absence of a pronounced depressing effect on the central nervous system, but in some cases, with individual hypersensitivity, a slight sedative effect is observed.
When taking sehifenadine, no changes in the biochemical parameters of blood and urine are observed, the drug does not affect blood pressure, ECG indicators, glucose and cholesterol concentrations in the blood, and does not affect EEG indicators.
It is rapidly absorbed from the gastrointestinal tract. cmax of the Active ingredient in blood plasma is reached in 1-2 hours. It accumulates mainly in the lungs, liver, and the lowest concentration is in the brain. It is metabolized by oxidation, forming a pharmacologically inactive metabolite.
After taking a single dose of 50 mg, T1/2 of the Active ingredient from the blood plasma is 12 hours, and after repeated doses it is shortened to 5-8 hours, i. e. sechifenadine does not accumulate in the body. 50% of the dose is excreted from the body through the intestines, more than 20% – by the kidneys. About 30% of the dose is excreted unchanged,40-50% – in the form of metabolites.
Indications
- allergic rhinitis;
- allergic conjunctivitis;
- pollinosis;
- urticaria;
- angioedema;
- allergic itchy dermatoses, including atopic dermatitis;
- prevention of allergic diseases before their seasonal exacerbation and maintenance therapy.
Contraindications
- hypersensitivity to the Active ingredient or excipients of the drug;
- bronchial asthma;
- pregnancy;
- lactation;
- children under 18 years of age;
- simultaneous use of MAO inhibitors.
The tablet contains lactose. The drug should not be used in patients with lactase deficiency, rare hereditary problems of lactose intolerance, or glucose / galactose malabsorption.
With caution: Â with impaired renal function, severe diseases of the cardiovascular system, gastrointestinal tract, and liver.
Side effects
Dry mouth, epigastric pain, dyspepsia, increased appetite, leukopenia, menstrual disorders, increased urination, headache, drowsiness.
Agitation, insomnia, which are more common when taking high doses.
Interaction
Sehifenadine does not increase the depressing effect on the central nervous system of sleeping pills and alcohol, but during treatment you should refrain from drinking alcohol.
How to take, course of use and dosage
Inside, after eating, with water. Adults with acute and chronic allergic diseases — 50-100 mg 2-3 times a day. Usually, the therapeutic effect occurs 3 days after the start of treatment. The duration of treatment is 5-15 days.
Prevention of allergic diseases before the period of their seasonal exacerbation and for maintenance therapy-50 mg 2 times a day. It is recommended to start taking the drug 2 weeks before the expected exposure to the seasonal allergen.
Overdose
Symptoms: Â dryness of the mucous membranes, headache, vomiting, abdominal pain.
Treatment: Â symptomatic therapy. The antidote is unknown.
Special instructions
There are no clinical studies on the use of the drug in children and senile patients (after 70 years).
Sehifenadine tablets can be combined with topical medications (ointment, eye drops, nose drops).
In most cases, drowsiness decreases or disappears 2-5 days after the start of treatment.
Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. People whose work requires a quick physical or mental reaction (transport drivers, etc. ) should refrain from driving vehicles and engaging in potentially dangerous activities during treatment.
Composition
Tablet Form of production
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 °C
Shelf life
4 years
Active ingredient
Sehifenadine
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as prescribed by a doctor, For adults
Indications
Dermatosis, Allergic Conjunctivitis, Urticaria, Allergy, Dermatitis, Allergic Rhinitis
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Side effects of Histafen, pills 50mg, 20pcs.
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