Бекіст-Сановель - instructions for use, doses, side effects, contraindications

Excipients: croscarmellose sodium 20 mg, microcrystalline cellulose 178 mg, pregelatinized starch 58 mg, silicon dioxide colloid 14 mg, povidone 6 mg, magnesium stearate 4 mg;

film coating: opadrai pink (lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, iron oxide red) 15.6 mg.

180 mg:

active substance: fexofenadine hydrochloride 180 mg;

Excipients: croscarmellose sodium 30 mg, microcrystalline cellulose 267 mg, pregelatinized starch 87 mg, silicon dioxide colloid 21 mg, povidone 9 mg, magnesium stearate 6 mg;

film coating: opadrai pink (lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, iron oxide red) 23.4 mg.

Description:

120 mg: oblong biconvex tablets covered with a film membrane of pale pink color without incisions.

180 mg: oblong biconvex tablets, covered with a film membrane of pale pink color without incisions.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X.26 Fexofenadine

Pharmacodynamics:

Fexofenadine is a specific antagonist of histamine H₁receptors. Fexofenadine in therapeutic doses does not possess anticholinergic, antiadrenergic or antidopaminergic activity. Even in high doses fexofenadine does not block potassium channels in myocardiocytes, thus, does not have a cardiotoxic effect (prolongation QT-Interval, arrhythmias). Fexofenadine does not pass through the blood-brain barrier and, therefore, does not interact with H₁receptors of the central nervous system (CNS).

Clinical trials conducted in adult patients with seasonal allergic rhinitis showed that taking the drug at a dose of 60, 120, 180 mg caused a rapid symptomatic improvement within 1 hour, the effect persisted for 24 hours.

Pharmacokinetics:

Suction. After oral administration fexofenadine quickly absorbed from the gastrointestinal tract (GIT), time to reach the maximum concentration (T_mOh) in plasma is approximately 1-3 hours. After ingestion of a dose of 60 mg once a day, the mean maximum concentration (C_mOh) is approximately 142 ng / ml, 120 mg once a day is approximately 289 ng / ml, and after oral administration, 180 mg once a day is approximately 494 ng / ml.

Metabolism, distribution and excretion. Binding to plasma proteins is 60-70%. Metabolized approximately 5% of the dose.80% and 11% of the accepted dose is excreted with bile and urine, respectively. The half-life (T_1/2) after repeated administration is 11-16 hours. 10% of the dose is excreted by the kidneys unchanged.

The pharmacokinetics of fexofenadine when administered to a single or multiple dose of 20 mg to 120 mg is linear. After taking the drug inside at a dose of 240 mg 2 times / day, there is a proportional increase in the area under the pharmacokinetic curve (AUC) (8,8%).

Indications:

120 mg: elimination of symptoms associated with seasonal allergic rhinitis.

180 mg: chronic urticaria: redness, itching, and other symptoms of hives.

Contraindications:

Hypersensitivity to the components of the drug.

Children under 12 years.

Pregnancy and lactation.

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Chronic renal failure, hepatic insufficiency, elderly age, cardiovascular diseases (including in the anamnesis).

Dosing and Administration:

Inside, adults and children over 12 years of age - 1 table. (120 or 180 mg, see section "Indications for use") once a day.

Side effects:

Headache, drowsiness, nausea, dyspepsia, dizziness, fatigue, fatigue, weakness, insomnia, nervousness, nightmarish dreams, tachycardia, diarrhea, exanthema, dyspnea, systemic anaphylactic reactions (skin rash, urticaria, itching, angioedema).

Overdose:

Symptoms: dizziness, drowsiness, dry mouth.

Treatment: carrying out of standard measures for removal from the gastrointestinal tract of a nonabsorbed preparation. Symptomatic and supportive therapy. Hemodialysis is ineffective.

Interaction:

Antacids can affect the effectiveness of fexofenadine. The recommended interval between fexofenadine and antacids containing aluminum or magnesium hydroxide is 2 hours.

With the simultaneous administration of fexofenadine with erythromycin or ketoconazole, fexofenadine in the plasma can be increased 2-3 times (not associated with a significant lengthening of the interval QT).

Does not interact with omeprazole, with drugs metabolized in the liver.

Special instructions:

Studies conducted in elderly patients in patients with impaired renal and hepatic function showed no need for dose adjustment.

Effect on the ability to drive transp. cf. and fur:

In carrying out objective tests it was shown that fexofenadine does not have a significant effect on the functions of the central nervous system. Nevertheless, in order to identify sensitive patients who have a non-standard response to a drug, it is recommended to check the individual response before proceeding with work that requires concentration.

Form release / dosage:

Tablets, film-coated, 120 mg and 180 mg.

Packaging:

10 tablets in a blister of PVC-aluminum foil.

For 1.2 blisters in a cardboard pack together with instructions for use.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001103

Date of registration:03.11.2011

The owner of the registration certificate:Sanovel Pharmaco-industrial trading companySanovel Pharmaco-industrial trading company Turkey

Manufacturer: & nbsp

SANOVEL PHARMACEUTICAL PRODUCTS IND., Inc. Turkey

Representation: & nbspSANOVEL branch of the company pharmaco-industrial trading companySANOVEL branch of the company pharmaco-industrial trading companyRussia

Information update date: & nbsp18.09.2015

Illustrated instructions

Instructions

Baxist-Sanovel (Beksist-Sanovel)