Fexadine, pills 120mg, 10pcs

Composition

Each film-coated tablet contains:

active ingredient:

Fexofenadine Hydrochloride 120 mg

Auxiliary ingredients:

Croscarmellose sodium-20.00 mg,

microcrystalline cellulose-177.42 mg,

gelatinized starch-58.00 mg,

colloidal silicon dioxide-14.00 mg,

povidone-6.0 mg,

magnesium stearate-4.00 mg,

purified water* – up to 400.00 mg.

Film shell:

Opadray pink dye (OY-54957) — 15.60 mg: (hypromellose, titanium dioxide, macrogol-400, iron oxide red dye (CI No. 77491), purified water*.

Printing Ink:

Opacode S-I-17823 black-Q. s. :

glazed shellac-45% (20% etherified) in ethanol, iron oxide black dye, N-butyl alcohol, propylene glycol, isopropanol, ammonium hydroxide 28%.

(*- evaporates during production).

Pharmacological action

Pharmacodynamics .

Fexofenadine hydrochloride is an H1-histamine receptor blocker with virtually no sedative effect. Fexofenadine is a pharmacologically active metabolite of terfenadine.

The antihistamine effect of the drug manifests itself 1 hour after ingestion, reaches a maximum in 6 hours and continues for 24 hours. After 28 days of use, there is no development of tolerance. When taking oral doses from 10 mg to 130 mg, there is a linear dose-effect relationship. For 24-hour effectiveness of the drug (for allergic rhinitis), a dose of 120 mg is sufficient. At a dose of up to 240 mg, the drug does not cause changes in the QT interval.

Fexofenadine hydrochloride after oral use is rapidly absorbed from the gastrointestinal tract, the time to reach the maximum concentration (cmax) is 1-3 hours. The average maximum concentration (Cmax) after taking a dose of 120 mg is 289 ng/ml, and after taking a dose of 180 mg — approximately 494 ng/ml. Plasma protein binding is 60-70% (mainly with albumin and alpha-1-glycoprotein). It does not cross the blood-brain barrier. Fexofenadine undergoes partial (5% of the dose) metabolism.

The output is two-phase. The half-life (T 1/2) after repeated use is from 11 to 15 hours. In patients with moderate (creatinine clearance 41-80 ml/min) and severe (11-40 ml/min) renal insufficiency T1/2 increased by 59 and 72%, respectively; for patients on hemodialysis, the T1/2 increased by 31%.

The pharmacokinetics of single and repeated application of Fexofenadine (up to 120 mg twice a day) is linear.

It is mainly excreted (80%) with bile, up to 10% of the dose taken is excreted unchanged in the urine.

Indications

Seasonal allergic rhinitis: sneezing, itching, rhinitis, redness of the eye mucosa and other symptoms of hay fever-tablets,120 mg;

Chronic idiopathic urticaria: redness, itching of the skin and other symptoms of urticaria-tablets,180 mg.

Contraindications

Hypersensitivity to any of the components of the drug, pregnancy, lactation, childhood (up to 12 years), chronic renal failure.

Side effects

Headache, drowsiness, nausea, dyspepsia, dizziness.

Rare (less than 1 case per 1000 appointments): feeling tired, insomnia, nervousness, sleep disturbance.

In some cases: skin rash, urticaria, pruritus, other hypersensitivity reactions: angioedema, shortness of breath.

Interaction

With the combined use of Fexadine with erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases 2-3 times.

There is no significant effect on the increase in the QT interval.

Taking aluminum-or magnesium-containing antacids 15 minutes before taking fexofenadine leads to a decrease in the bioavailability of the latter (the time interval between taking them should be at least 2 hours).

It does not interact with omeprazole.

How to take, course of use and dosage

Tablets are intended for oral use.

The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years and older is 120 mg once a day.

The recommended dose of fexofenadine for chronic urticaria for adults and children 12 years and older is 180 mg once a day.

Overdose

Symptoms: dizziness, drowsiness, and dry mouth.

In case of overdose, it is recommended to carry out standard measures to remove the unabsorbed drug from the gastrointestinal tract.

Symptomatic and supportive care is recommended.

Hemodialysis is ineffective.

Special instructions

In older patients or patients with hepatic insufficiency, fexofenadine should be used with caution due to the lack of data. It is recommended that the time interval between taking fexofenadine hydrochloride and antacids containing aluminum hydroxide or magnesium be 2 hours.

Impact on the ability to drive a car and perform tasks that require concentration of attention

When taking the drug Fexadin, it is possible to perform work that requires high concentration of attention and speed of psychomotor reactions (with the exception of people who have a non-standard reaction to medications). Thus, before starting to perform these tasks (driving vehicles, controlling mechanisms), it is necessary to first check the individual reaction to the drug.

Form of production

Film-coated tablets

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Fexofenadine

Dosage form

Tablets

Description

Children over 12 years old, For adults

Indications

Hay Fever, Allergic Rhinitis, Allergic Conjunctivitis, Allergy