Allegra pills 120mg, 10pcs

Composition

Tablets covered with a film-coated light pink color, oblong, biconvex, with an engraving “012” on one side and a stylized “e” on the other.

Auxiliary substances:

croscarmellose sodium – 24 mg,

pregelatinized starch-120 mg,

microcrystalline cellulose-133 mg,

magnesium stearate-3 mg.

Shell composition:

hypromellose E-15 – 2.84 mg, hypromellose E-5 – 1.89 mg, povidone – 510 µg, titanium dioxide (E 171) – 2.025 mg, silicon dioxide colloid – 730 µg, macrogol 400 – 3.94 mg, pink dye mixture of iron oxide (iron oxide red (E 172), titanium dioxide (E 171)) – 250 mcg, yellow dye mixture of iron (iron oxide yellow (E 172), titanium dioxide (E 171)) – 40 mg.

Pharmacological action

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

In human studies 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 taking it.

Even after 28 days of taking fexofenadine, no tolerance to the drug was detected. With a single oral dose of fexofenadine, there is a dose-dependent increase in the antihistamine effect with an increase in the dose from 10 mg to 130 mg. When using the same model of antihistamine action, it was found that a dose of at least 130 mg was required for a constant 24-hour action. The maximum suppression of blistering and hyperemia of the skin is more than 80%.

In patients with seasonal allergic rhinitis who received up to 240 mg of fexofenadine twice daily for 2 weeks, the duration of the QTc interval (corrected QT) did not differ from that with placebo.

There were also no changes in QTc when fexofenadine was administered to healthy volunteers at 60 mg twice daily for 6 months,400 mg twice daily for 6.5 days, and 240 mg daily for 1 year compared to the duration of QTc when taking placebo.

Even at a plasma concentration 32 times higher than therapeutic concentrations in humans, fexofenadine had no effect on 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.

Use during pregnancy and lactation

Pregnancy

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

Lactation

There are no data on the content of fexofenadine in breast milk when it is 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 breast-feeding is not recommended.

Contraindications

-hypersensitivity to any of the components of the drug

— – pregnancy;

– lactation period

— – children’s age (up to 12 years).

With 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 in the anamnesis (antihistamines can cause palpitations and tachycardia).

With impaired renal function.

Use with caution in patients with chronic renal failure. No dosage adjustment is required.

With impaired liver function.

Use with caution in patients with chronic hepatic insufficiency. No dosage adjustment is required.

Side effects

In placebo-controlled clinical trials, headache (7.3%), drowsiness(2.3%), dizziness (1.5%), and nausea (1.5%) were most common (≥1%). When taking fexofenadine, the incidence of the above adverse effects was similar to that of placebo.

In placebo-controlled studies with a frequency of less than 1% (the same with fexofenadine and placebo) and with post-marketing use of the drug, there were weakness, insomnia, nervousness and sleep disorders or unusual dreams (paronyria), such as nightmares; tachycardia, palpitations; diarrhea.

Interaction

When fexofenadine is co-administered with erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases 2-3 times, but this 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 above-mentioned increase in plasma concentrations of fexofenadine is probably associated with an improvement in the absorption of fexofenadine and a decrease in its biliary excretion or secretion into the gastrointestinal tract.

There is no interaction between fexofenadine and omeprazole.

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

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

How to take, course of use and dosage

Tablets are intended for oral use.

The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years and older is 120 mg once a day before meals.

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

At-risk patients

Studies in special risk groups (elderly patients, patients with renal and hepatic insufficiency) have shown that they do not need to adjust the dosage regimen.

Overdose

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

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

Special instructions

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

For use in children from 6 to 11 years,30 mg tablets are available.

Influence on the ability to drive motor vehicles and manage mechanisms

When taking the drug, it is possible to perform work that requires high concentration of attention and speed of psychomotor reactions (with the exception of patients with non-standard reactions).

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

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Fexofenadine

Dosage form

Tablets

Description

For adults, Children over 12 years of age

Indications

Allergic Conjunctivitis, Allergy, Allergic Rhinitis, Pollinosis, Urticaria