Гифаст 180 mg

General characteristics. Structure:

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

Excipients: cellulose microcrystallic, starch corn prezhelatinizirovanny, silicon dioxide colloid (aerosil), povidone (Kollidon 30), кросповидон (Kollidon CL-M), sodium of a kroskarmeloz, magnesium stearate.

Structure of a film cover: Опадрай II (series 85) [the polyvinyl alcohol which is partially hydrolyzed a macrogoal 3350 (polyethyleneglycol 3350), talc, titanium dioxide, an aluminum varnish on the basis of dye of a sunset yellow, dye ferrous oxide yellow, dye ferrous oxide red].

Pharmacological properties:

Pharmacodynamics. Feksofenadin a hydrochloride is not sedative blocker of H1 – histamine receptors, represents pharmacological an active metabolite of a terfenadin. The antihistaminic effect is shown in 1 hour after reception, reaches a maximum in 6 hours and proceeds within 24 hours. At repeated use tolerance development is noted. Has no well-cared and adrenolytic, sedative effect. Does not cause changes of function of calcium and potassium channels, QT interval in therapeutic doses.

Pharmacokinetics. After intake time of achievement of the maximum concentration (TCmax) - 1-3 h is quickly absorbed from digestive tract. Average value of the maximum concentration (Cmax) after reception of 180 mg - about 494 ng/ml, after reception of 120 mg - 427 ng/ml. Communication with proteins of plasma - 60-70% (it is preferential with albumine and an alfa1-glycoprotein). Does not get through a blood-brain barrier.

Elimination half-life (T1/2) after multiple dose - 14,4 h. At patients with moderated (clearance of creatinine of 41-80 ml/min.) and heavy (11-40 ml/min.) a renal failure of T1/2 increases by 59 and 72% respectively; at the patients who are on a hemodialysis, T1/2 increases by 31%.

Is exposed (5% of a dose) to partial extrahepatic metabolism. 11% - kidneys in not changed look are removed preferential (80%) with bile.

Indications to use:

Seasonal allergic rhinitis, chronic small tortoiseshell.

Route of administration and doses:

Inside. At a chronic small tortoiseshell on 180 mg once a day.

Features of use:

At administration of drug of Gifast performance of work, the demanding high concentration of attention and speed of psychomotor reactions is possible (except for the people possessing non-standard reaction to medicines). Thus, before starting performance of these works (driving of motor transport, control of mechanisms) it is necessary to check individual reaction to drug at first.

Side effects:

Headache, drowsiness, nausea, dizziness.

Seldom (less than 1 case on 1000 appointments): feeling of fatigue, sleeplessness, nervousness, sleep disorder.

In some cases: skin rash, small tortoiseshell, skin itch, other reactions of hypersensitivity (Quincke's disease, asthma).

Interaction with other medicines:

At combined use with erythromycin or ketokonazoly concentration of a feksofenadin in plasma increases by 2-3 times.

Reception aluminum - or magniysoderzhashchy antacids in 15 min. prior to reception of a feksofenadin leads to decrease in bioavailability of the last (time interval between their reception has to be not less than 2 h).

Does not interact with omeprazoly, with the drugs which are metabolized in a liver.

Contraindications:

Hypersensitivity, pregnancy, the lactation period, children's age (up to 12 years).

With care: A chronic renal failure (the recommended daily dose at such patients of 60 mg once).

Overdose:

Symptoms: dizziness, drowsiness and dryness in a mouth. In case of overdose carrying out standard measures for removal from digestive tract of not absorbed drug is recommended.

The symptomatic and maintenance therapy is recommended. The hemodialysis is inefficient.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 2 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 180 mg. On 10 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2 or 3 blister strip packagings with the application instruction in a pack from a cardboard.