MANUAL for medical use of the drug
Composition of the drug:
active substance: one tablet contains 120 mg or 180 mg of Fexofenadine hydro chloride;
excipients: microcrystalline cellulose, starch, lactose, Primerose, povidone, silica colloidal anhydrous, harakterom ethyl cellulose, propylene glycol, purified talc, titanium dioxide, magnesium stearate, colorant, Sunset Yellow Lake (tablet 180 mg).
Dosage form. Tablets, film-coated.
Pills 120 mg: white or almost white, round convex coated tablets.
Tablets 180 mg: tablets are orange, oblong, film coated.
The name and location of manufacturer. Micro Labs Limited
92, Spot, Hosur-635126, India.
Pharmacotherapeutic group. Antihistamines for systemic use.
ATC code R06A X26.
The pharmacological properties. Fexofenadine, an active metabolite of terfenadine, is antiglamour means with selective blocking of H1-histamine receptors. Fexofenadine is able to stop the antigen-induced bronchospasm in sensibleone Guinea pigs and histamine release from peritoneal mast cells of rats. In laboratory animals indicated the absence of anticholinergic effects or alpha1-adrenergize lock. In addition, the drug has no sedative effect.
Pharmacokinetics. Fexofenadine hydro chloride is rapidly absorbed from the gastrointestinal tract after oral administration, maximum concentration in plasma is approximately of 2.6 hours After single oral administration of 180 mg of the drug its concentration in the blood plasma amounted to 494 ng/ml, after administration of 120 mg – 427 ng/ml.
60 - 70% adopted Fexofenadine associated with blood plasma proteins.
Fexofenadine undergoes negligible metabolic changes (liver and outside the liver), so it is found in the urine and faeces of animals and people mostly unaltered.
The half excretion Fexofenadine is 14.4 hours. It is excreted mainly with bile, while up to 10 % of the dose excreted unchanged by the kidneys.
Indications for use. For the relief of symptoms associated with seasonal allergic rhinitis (sneezing, rhinorrhea, itchy nose/sky/throat, itchy/watery/red eyes), symptomatic treatment of chronic urticaria.
Contraindications. Hypersensitivity to the drug, child age to 12 years.
Appropriate security measures when using. Teksoft should be used with caution in elderly patients and in the presence of liver or kidney on the basis of lack of sufficient experience in the use of Fexofenadine hydro chloride in patients of these groups.
Special warnings. Pregnancy and lactation. Adequate and well-controlled studies of the effect of the drug in women during lactation have not been conducted. You have to be careful when prescribing the drug to women who breast-feed, or should decide the issue of termination of breastfeeding based on the fact that Fexofenadine hydro chloride is able to penetrate into breast milk.
The use of the drug during pregnancy is possible only in cases when the expected benefit to the mother outweighs the potential risk to the fetus.
The ability to influence on reaction rate while managing transport a car or other mechanisms. Before you start the vehicle, it is recommended to check individual response on Fexofast.
Method of application and doses. Adults and children over 12 years: depending on indications: for symptomatic treatment of chronic hives - 180 mg Fixiate 1 time per day; for the relief of symptoms associated with seasonal allergic rhinitis is 120 mg Fixiate 1 time per day.
Overdose. In case of overdose of Fexofast, you should take standard measures (gastric lavage) to remove the drug. Recommended symptomatic and supportive therapy. Hemodialysis is not effective for removing Fexofenadine from the blood.
Side effects. During clinical trials, the most frequently observed side effects:
CNS: headache, drowsiness, dizziness and fatigue;
the gastro-intestinal tract: nausea.
Adverse events were similar in patients who took Fexomat and placebo. Side effects, including drowsiness, was not associated with age, sex and race and depended on the dose.
Interaction with other medicinal products and other forms of interaction. While the use of Fexofena with other drugs may their interaction (compatible with erythromycin or ketoconazole concentration of Fexofenadine in the plasma increased
2-3 times). Fexofenadine is not biotransformiroetsa in the liver and does not interact with other drugs that are metabolized by the liver.
While taking antacids (Almagel and other drugs that contain aluminum or magnesium) for 15 min before the application of Fexofenadine a decrease in its bioavailability. It is therefore recommended that the interval between doses of Fexofenadine and such antacids made up
The expiration term. 3 years.
The storage conditions. Keep at temperature not exceeding 25 ° C in a dry and inaccessible to children.
Packing. 10 tablets per blister; 3 blisters in a carton made of cardboard.
4 tablets per blister; 1 blister in a carton made of cardboard.