Allegra, 180 mg 10 pcs

Fexofenadine (pharmacologically active metabolite of terfenadine) is an antihistamine with selective antagonistic activity to H1-receptors without anticholinergic and blocking alpha-adrenergic receptors. Besides this, fexofenadine has no sedative action and other effects on the central nervous system.

In human studies evaluating histamine-induced blistering and hyperemia, the antihistamine effect of fexofenadine taken orally once or twice daily is seen after 1 hour, peaks after 6 hours, and continues for 24 hours after its administration. Even after 28 days of taking fexofenadine, no development of tolerance to the drug has been identified.

A single oral administration of fexofenadine shows a dose-dependent increase in antihistamine effect with dose increases 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 required for continuous action over 24 hours. Maximum suppression of blistering and skin hyperemia was over 80%.

In patients with seasonal allergic rhinitis receiving up to 240 mg of fexofenadine 2 times daily for 2 weeks, QTc (QT corrected) interval duration was not different from that with placebo.

There was also no change in QTc when fexofenadine was taken by healthy volunteers at 60 mg 2 times daily for 6 months, 400 mg 2 times daily for 6.5 days, and 240 mg daily for 1 year compared with QTc duration when taking placebo.

Even at plasma concentrations 32 times therapeutic concentrations in humans, fexofenadine had no effect on delayed rectifier potassium channels in the human heart.

Indications

Chronic idiopathic urticaria (to reduce symptoms).

Active ingredient

Composition

In 1 film-coated tablet contains:

acting substance:

fexophenadine hydrochloride – 180.0 mg.

Auxiliary substances:

croscarmellose sodium – 24.0 mg,

pregepatinized starch – 120.0 mg,

microcrystalline cellulose – 133.0 mg,

magnesium stearate – 3.0 mg.

composition of the film coating:

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 oxide dye (pink mixture*) – 0.025 mg, iron oxide dye (yellow mixture**) – 0.040 mg.

* – Pink mixture of iron oxide dye is a mixture of iron oxide red (E 172) and titanium dioxide (E 171).
** – Yellow mixture of iron oxide dye is a mixture of iron oxide yellow (E 172) and titanium dioxide (E 171).

How to take, the dosage

The tablets are for oral administration.

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

Patients at risk groups

Studies in special risk groups (elderly patients, patients with renal and hepatic impairment) have shown that no dosage adjustment is necessary in them.

Interaction

When co-administration of fexofenadine with erythromycin or ketoconazole the plasma concentration of fexofenadine is increased by 2-3 times, but it is not associated with a significant prolongation of the QTc interval. There were no significant differences in the incidence of adverse effects when using these drugs in monotherapy and in combination. Animal studies have shown that the aforementioned increase in plasma concentrations of fexofenadine is probably due to improved absorption of fexofenadine and a decrease in its biliary excretion or secretion into the GI tract.

There is no interaction between fexofenadine and omeprazole.

It does not interact with drugs that are metabolized in the liver.

The intake of antacids containing aluminum or magnesium 15 minutes before taking fexofenadine results in decreased bioavailability of the latter due to apparent binding in the gastrointestinal tract.

Special Instructions

It is recommended that there should be at least 2 hours between taking fexofenadine and antacids containing aluminum or magnesium hydroxide.

The 30 mg tablets are available for use in children from 6 to 11 years of age.

Impact on ability to drive and operate machinery

When taking the drug, it is possible to perform work requiring high concentration and quick psychomotor reactions (except for patients with non-standard reactions).

Therefore, it is recommended to check the individual response to fexofenadine before engaging in these activities.

Contraindications

With caution: in patients with chronic renal and hepatic insufficiency, as well as in elderly patients (insufficient clinical experience with this category of patients); in patients with cardiovascular diseases, including in the anamnesis (antihistamines may cause palpitation and tachycardia).

Side effects

In placebo-controlled clinical trials, the most frequent (≥1% –

In placebo-controlled studies with an incidence of less than 1% (equal for fexofenadine and placebo) and in postmarketing use of the drug were weakness, insomnia, nervousness, and sleep disturbances or unusual dreams (paronyria) such as nightmares; tachycardia, palpitations; and diarrhea.

Overdose

Symptoms: dizziness, drowsiness, and dry mouth. Healthy volunteers took single doses up to 800 mg, and course doses up to 690 mg 2 times daily for 1 month or 240 mg 2 times daily for 1 year without any significant adverse effects compared with placebo. The maximum tolerated dose for fexofenadine has not been established.

Treatment: in case of overdose gastric lavage, activated charcoal administration, symptomatic and supportive therapy if necessary are recommended. Hemodialysis is ineffective.

Pregnancy use

Pregnancy

There are insufficient data on the use of fexofenadine in pregnant women. Limited animal studies have shown no evidence of adverse effects on pregnancy, intrauterine development, birth, and postnatal development. Fexofenadine should not be used in pregnancy.

Lactation

There are no data on the content of fexofenadine in breast milk when administered to breastfeeding women. However, when terfenadine was taken it was observed to penetrate into the breast milk of lactating women. Therefore, the use of fexofenadine during breastfeeding is not recommended.

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