Fencarol (hifenadina hydrochloride) tablets 10 mg. №20

Description

Fencarol 10 mg Storage
active substance: hyfenadine;

1 tablet contains hyphenadine hydrochloride 10 mg;

excipients: sucrose, potato starch, calcium stearate.

Fencarol 10 mg Dosage form
Tablets.

Main physical and chemical properties: flat-cylindrical tablets of white or almost white color, with a bevel and a dash on one side of the tablet.

Fencarol 10 mg Pharmacotherapeutic group
Antihistamines for systemic use.

ATX code R06A X31.

Pharmacological properties

Pharmacodynamics.

The active substance in Fencarol® is a quinuclidylcarbinol derivative that reduces the effects of histamine on organs and systems. Hifenadine is a competitive H1-receptor blocker. In addition, it activates the enzyme diamine oxidase, which breaks down approximately 30% of endogenous histamine. This explains the effectiveness of hyfenadine in patients insensitive to other antihistamines. Hifenadine is poorly penetrated through the blood-brain barrier and has little effect on the deamination of serotonin in the brain, has little effect on monoamine oxidase activity. The antihistamine properties of hyfenadine are associated with the presence of a cyclic quinuclidine nucleus in the structure and the distance between the diphenylcarbinol group and the nitrogen atom. Diphenhydramine predominates in antihistaminic activity and duration of action. Hifenadine reduces the toxic effect of histamine, relieves or weakens its bronchoconstrictor effect and spasmodic effect of intestinal smooth muscle, has a moderate antiserotonin and weak cholinolytic effect, well-defined antipruritic and desensitizing properties.

Hifenadine weakens the antihypertensive effect of histamine and its effect on capillary permeability, does not directly affect cardiac activity and blood pressure, has no protective effect in aconitine arrhythmias.

Hifenadine has no depressant effect on the central nervous system, but with individual hypersensitivity, a weak sedative effect is possible. The drug has low lipophilicity, so its content in brain tissues is low (less than 0.05%), which explains the lack of depressant effect on the central nervous system.

Pharmacokinetics.

Hifenadine is rapidly absorbed from the gastrointestinal tract and after 30 minutes is detected in body tissues. The maximum concentration in blood plasma is reached in 1 hour.

Metabolites and a constant proportion of hyfenadine are mainly excreted in the urine, bile and lungs within 48 hours. Fencarol® is metabolized in the liver.

Indication
Pollinosis, food and drug allergies, other allergic diseases, acute and chronic urticaria, Quincke’s edema (angioneurotic), hay fever, allergic rhinopathy, dermatoses (eczema, neurodermatitis, itchy skin), as well as infectious-allergic reactions with bronchitis.

Contraindication
Hypersensitivity to hyphenadine hydrochloride or to excipients.

Interaction with other medicinal products and other forms of interaction
The drug does not enhance the depressant effect of alcohol and sleeping pills on the central nervous system. Fencarol® has weak M-cholinoblocker properties, but in the case of reduced motility of the gastrointestinal tract, the absorption of slowly adsorbed drugs may be enhanced (eg indirect anticoagulants – coumarins).

Features of application
Caution should be exercised when prescribing the drug in severe diseases of the cardiovascular system, gastrointestinal tract, liver and / or kidneys.

The drug contains sucrose, which should be considered by patients with diabetes.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

Use during pregnancy or breastfeeding
It is contraindicated to prescribe the drug during the first trimester of pregnancy.

The drug is not recommended during the second and third trimesters of pregnancy.

There are no data on the penetration of the drug into breast milk, so the use of the drug is contraindicated during breastfeeding.