Description
Latin name
Allegra
Release form
Pills, film-coated, light pink, oblong, biconvex, engraved 012 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 a human study evaluating histamine-induced blisters and hyperemia, the antihistamine effect of fexofenadine, taken orally once or twice a day, manifests itself after 1 hour, reaches a maximum after 6 hours, and continues for 24 hours after it is taken. 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 who received 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 of 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 with 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
– seasonal allergic rhinitis (to reduce symptoms) – tablets, 120 mg
– chronic idiopathic urticaria (to reduce symptoms) – tablets, 180 mg.
Contraindications
– hypersensitivity to any of the components of the drug
– pregnancy
– lactation period
– childhood (up to 12 years).
Precautions:
– in patients with chronic renal and hepatic insufficiency, as well as in elderly patients (lack of clinical experience with this category of patients)
– in patients with cardiovascular diseases, including a history of (antihistamines can cause palpitations and tachycardia).
In case of impaired renal function.
Use with caution in chronic renal failure. No dosage adjustment is required.
In case of impaired liver function.
Use with caution in chronic liver failure. No dosage adjustment is required.
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.
Ingredients
Excipients: croscarmellose sodium – 24 mg, starch pregelatinized – 120 mg mg, microcrystalline cellulose – 133 mg, magnesium stearate – 3 mg.
Shell composition: E-15 hypromellose – 2.84 mg, E-5 hypromellose – 1.89 mg, povidone – 510 μg, titanium dioxide (E171) – 2.025 mg, colloidal silicon dioxide – 730 μg, macrogol 400 – 3.94 mg, pink dye mixture iron oxide (iron oxide red (E172), titanium dioxide (E171)) – 250 μg, a yellow mixture of iron dye (iron oxide yellow (E172), titanium dioxide (E171)) – 40 μg.
Dosage and administration
Tablets are for oral administration.
The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years of age and older is 120 mg 1 time per day before meals.
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, the most common ( 1% headache (7.3%), drowsiness (2. 3%), dizziness (1.5%) and nausea 1.5%. When taking fexofenadine, the frequency of the above adverse effects was similar to that when taking placebo.
In a placebo-controlled study with a frequency of less than 1% (the same when taking fexofenadine and placebo) and post-marketing use of the drug, there were weakness, insomnia, nervousness and sleep disturbances, or unusual dreams (paroniria), such as nightmares, tachycardia, palpitations, diarrhea.
Drug Interaction
When co-administered with fexofenadine with erythromycin or ketoconazole, the plasma concentration of fexofenadine is increased 2-3 times, but this is not associated with a significant QTc lengthening. 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 ° C. Keep out of the reach of children!
Expiration
3 years.
Dispay conditions at the
pharmacy Over-the-counter
dosage form
dosage form
tablets
Sanofi-Aventis, France
