Fexofenadine | Allegra tablets are covered.pl.ob. 180 mg 10 pcs.

Latin name

Allegra

Release form

Tablets, coated with a light pink shell, oblong, biconvex, engraved 018 on one side and stylized e on the other.



packaging 10 pcs - blisters (1) - packs of cardboard.

Pharmacological action

Fexofenadine (a pharmacologically active metabolite of terfenadine) is an antihistamine with selective antagonistic activity to H1 receptors without anticholinergic and alpha-blocking alpha-adrenergic receptors. In addition, fexofenadine does not have a sedative effect or other effects from the central nervous system.

In human studies evaluating histamine-induced blisters and hyperemia, the antihistamine action of fexofenadine, taken orally once or twice a day, appears after 1 hour, reaches a maximum after 6 hours, and lasts for 24 hours after its administration. Even after 28 days of taking fexofenadine, there was no development of tolerance to the drug. With a single oral administration of fexofenadine, a dose-dependent increase in the antihistamine effect is observed with a dose increase from 10 mg to 130 mg. Using the same model of antihistamine action, it was found that a dose of at least 130 mg was necessary for continuous action within 24 hours. The maximum suppression of the formation of blisters and hyperemia of the skin is more than 80%.

In patients with seasonal allergic rhinitis, receiving up to 240 mg of fexofenadine 2 times a day for 2 weeks, the duration of the QTc interval (QT corrected) did not differ from that when taking a placebo.

Also, there were no changes in QTc when taking fexofenadine by healthy volunteers, 60 mg 2 times a day for 6 months, 400 mg 2 times a day for 6.5 days and 240 mg per day for 1 year compared with the duration of QTc when taken placebo.

Even at a plasma concentration 32 times the therapeutic concentration in humans, fexofenadine did not affect the potassium channels of delayed rectification in the human heart.

Indications

Chronic idiopathic urticaria (to reduce symptoms)

Contraindications

hypersensitivity to any of the components of the drug Allegra

pregnancy

lactation

child age (up to 12 years).

Caution: in patients with chronic renal and hepatic insufficiency, as well as in elderly patients (lack of clinical experience in this category of patients) in patients with cardiovascular diseases, including a history (antihistamines can cause palpitations and tachycardia).

Use during pregnancy and lactation

Pregnancy

There is not enough data on the use of fexofenadine in pregnant women. Limited animal studies have shown no signs of adverse effects on pregnancy, prenatal development, childbirth, and postnatal development. Fexofenadine should not be used during pregnancy.

Lactation

There are no data on the content of fexofenadine in breast milk when taken by breast-feeding women. However, when taking terfenadine, its penetration into the breast milk of lactating women was observed. Therefore, the use of fexofenadine during the lactation period is not recommended.

Composition

In 1 film-coated tablet contains: active substance: fexofenadine hydrochloride - 180.0 mg.

excipients: croscarmellose sodium - 24.0 mg, pre-gelatinized starch - 120.0 mg, microcrystalline cellulose - 133.0 mg, magnesium stearate - 3.0 mg.

film composition: hypromellose E-15 - 2.84 mg, hypromellose E-5 - 1.89 mg, povidone - 0.51 mg, titanium dioxide (E 171) - 2.025 mg, colloidal silicon dioxide - 0.73 mg, macrogol 400 - 3.94 mg, iron dye oxide (pink mixture *) - 0.025 mg, iron dye oxide (yellow mixture **) - 0.040 mg

* - the pink mixture of iron oxide dye is a mixture of red iron oxide (E 172) and titanium dioxide (E 171).

** - the yellow mixture of iron oxide dye is a mixture of yellow iron oxide (E 172) and titanium dioxide (E 171).

Dosage and administration

Tablets are for oral administration.

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

Patients at risk

Studies in special risk groups (elderly patients, patients with renal and hepatic insufficiency) showed that they do not require correction of the dosage regimen.

Side effects of

In placebo-controlled clinical trials most often ( 1% -

in placebo-controlled trials with a frequency of less than 1% (the same when taking fexofenadine and placebo) and with post-marketing use of the drug there were weakness, insomnia, nervousness and disturbance sleep or unusual dreams (paroniria), such as nightmares, tachycardia, palpitations of diarrhea.

Drug Interaction

When co-administered with fexofenadine with erythromycin or ketoconazole, plasma concentration of fexofenadine is increased by 2-3 times, but this is not associated with a significant prolongation of the QTc interval. No significant differences were observed in the incidence of adverse effects in the use of these drugs in monotherapy and in combination. Animal studies have shown that the aforementioned increase in plasma concentrations of fexofenadine is likely to be associated with an improvement in the absorption of fexofenadine and a decrease in its biliary excretion or secretion into the gastrointestinal lumen.

No interaction was observed between fexofenadine and omeprazole.

Does not interact with medicines metabolised in the liver.

Taking aluminum or magnesium antacids 15 minutes before receiving fexofenadine leads to a decrease in the bioavailability of the latter as a result of apparently binding in the gastrointestinal tract.

Overdose

Symptoms: dizziness, drowsiness and dry mouth. Healthy volunteers were given single doses up to 800 mg and course doses up to 690 mg 2 times a day for 1 month or 240 mg 2 times a day for 1 year with no significant adverse effects compared to placebo. The maximum tolerated dose for fexofenadine has not been established.

Treatment: in case of overdose, it is recommended to carry out gastric lavage, activated charcoal, symptomatic and supportive therapy if necessary. Hemodialysis is ineffective.

Storage conditions

At a temperature not exceeding 25 РC. Keep out of the reach of children!

Expiration

3 years.

dosage form

dosage form

tablets

Sanofi-Aventis, France