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Allergo

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Producer: Agio Pharmaceuticals Ltd. (Adzhio Pharmasyyutikals Ltd.) India

Code of automatic telephone exchange: R06AX26

Release form: Firm dosage forms. Tablets.

Indications to use: Allergic rhinitis (cold). Chronic idiopathic small tortoiseshell.


General characteristics. Structure:

Active ingredient: 120 mg or 180 mg of a feksofenadin of a hydrochloride.

Excipients: cellulose microcrystallic, starch corn, silicon dioxide colloid anhydrous, sodium of a kroskarmelloz, magnesium stearate.

Cover: mix Instacoat Sol IC-S-5289 Brown (talc, gidroksipropilmetiltsellyuloz, polyethyleneglycol, dyes: titanium dioxide (Е 171), ferrous oxide yellow (Е 172), ferrous oxide red (Е 172)).




Pharmacological properties:

Pharmacodynamics. Feksofenadin as an active metabolite of a terfenadin is antihistamine with the selection blocking peripheral histamine H1 receptors. Stabilizes membranes of mast cells, interferes with release of a histamine. Has no sedative effect. The antihistaminic effect of drug is shown from the first hour after reception, reaches a maximum in 6 hours and remains within 24 hours. Within 28 days of continuous use tolerance development is noted.

Pharmacokinetics. After intake it is quickly soaked up in digestive tract. The maximum concentration in a blood plasma is reached approximately in 1-3 hours. Average value of the maximum concentration after reception of a dose of 180 mg of 1 times a day made about 494 ng/ml after reception of a dose of 120 mg – 427 ng/ml. Feksofenadin for 60-70% contacts proteins of a blood plasma, is metabolized in insignificant degree (metabolism hepatic and nepech_nkovy). Does not get through a blood-brain barrier. The elimination half-life makes about 14 hours. It is removed preferential with bile, to 10% of the accepted dose it is allocated with urine in not changed look.


Indications to use:

Tablets of 120 mg: symptomatic treatment of seasonal allergic rhinitis.

Tablets of 180 mg: symptomatic treatment of a chronic idiopathic small tortoiseshell.


Route of administration and doses:

Drug is accepted inside to food, without chewing and washing down with liquid (for example, 1 glass of water).

To adults and children 12 years are more senior appoint on 1 tablet 120 mg at seasonal allergic rhinitis and on 1 tablet of 180 mg – at a chronic idiopathic small tortoiseshell, 1 time a day. Duration of treatment depends on the course of a disease and is established by the doctor.


Features of use:

It is necessary to be careful at use to patients of advanced age, and also patients with renal failures and a liver because of insufficiency of data.

Use during pregnancy or feeding by a breast. Use of drug during pregnancy is contraindicated. Feksofenadin gets into breast milk therefore it is impossible to apply it during feeding by a breast.

Ability to influence speed of response at control of motor transport or work with other mechanisms. During use of drug it is necessary to keep from control of motor transport and performance of the work demanding the increased concentration of attention and speed of psychomotor reactions.

Children. Apply in given to a dosage to children 12 years are more senior.


Side effects:

From a nervous system: a headache, dizziness, fatigue, drowsiness, in some cases – a hyperexcitability, frustration of a dream, taste disturbance.

From the alimentary system: nausea, dryness in a mouth, diarrhea.

Others: seldom – dryness in a nasal cavity and/or a throat, tachycardia, in some cases – skin rashes, an itch, urticaria, short wind, a stethalgia, reactions of a photosensitization, anaphylactic reactions, including a Quincke's disease.

In case of any undesirable reactions it is necessary to see a doctor immediately.


Interaction with other medicines:

Feksofenadin does not biotransformirutsya in a liver and therefore does not interact with other drugs which are metabolized by microsomal enzymes of a liver.

At combined use of a feksofenadin and erythromycin or a ketokonazol concentration of a feksofenadin in a blood plasma increases by 2-3 times that is caused by growth of gastrointestinal absorption and reduction of removal and biliary secretion. These changes do not influence QT interval on the electrocardiogram. Interaction between feksofenadiny and omeprazoly was not observed.

Reception of the antiacid means containing aluminum or magnesium in 15 minutes prior to reception of a feksofenadin leads to reduction of its bioavailability probably due to binding in the alimentary system. It is recommended that an interval between reception of a feksofenadin and antacids, the containing aluminum or magnesium hydroxide, made 2 hours.


Contraindications:

Hypersensitivity to a feksofenadin and other components of drug.

Children's age up to 12 years.

Period of pregnancy and feeding by a breast.


Overdose:

At overdose drowsiness, dizziness, increased fatigue, a headache, nausea are observed. In cases of overdose it is necessary to wash out a stomach, to appoint sorbents. Therapy is symptomatic. Use of a hemodialysis for removal of a feksofenadin from blood is inefficient.


Storage conditions:

Period of validity - 2 years. To store in the dry place at a temperature not over 25 ºС. To store in the place, unavailable to children.


Issue conditions:

Without recipe


Packaging:

On 10 tablets in the blister. On 1 blister in a cardboard box.



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