Allegra tablets p / o 120mg, No. 10

Seasonal allergic rhinitis (for symptom relief) - 120 mg tablet.

The tablets are intended for oral administration.

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

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

Patients at risk

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.

One tablet contains:

Active ingredient: fexofenadine hydrochloride - 120.0 mg.

Excipients: croscarmellose sodium - 24.0 mg, pregelatinized starch - 120.0 mg, microcrystalline cellulose -133.0 mg, magnesium stearate - 3.0 mg.

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

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

• Hypersensitivity to any component of the drug.

• Pregnancy.

• Lactation period.

• Children's age (up to 12 years old).

Carefully:

- 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, see the section 'Side effects').

Tradename:

Allegra.

International non-proprietary name:

fexofenadine.

Dosage form:

film-coated tablets.

Composition

For a dosage of 120 mg

One tablet contains:

Active ingredient: fexofenadine hydrochloride - 120.0 mg.

Excipients: croscarmellose sodium - 24.0 mg, pregelatinized starch - 120.0 mg, microcrystalline cellulose -133.0 mg, magnesium stearate - 3.0 mg.

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

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

Description

For a dosage of 120 mg: oblong, biconvex film-coated tablets of light pink color, engraved with 012 on one side , and stylized 'e' on the other.

Pharmacological group:

antiallergic agent - H1-histamine receptor blocker.

pharmachologic effect

Pharmacodynamics

Fexofenadine (the pharmacologically active metabolite of terfenadine) is an antihistamine with selective H1 receptor antagonistic activity without anticholinergic and alpha1-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 its administration. Even after 28 days of taking fexofenadine, there was no development of tolerance to the drug. With a single dose of fexofenadine inside, a dose-dependent increase in the antihistamine effect is observed with an increase in the dose 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 a constant action over 24 hours. The maximum suppression of blistering and skin flushing 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 Qlx interval (corrected QT) did not differ from that of 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 to the duration of QTc with taking a placebo.

Even at a plasma concentration 32 times the therapeutic concentration in humans, fexofenadine had no effect on the delayed-straightening potassium channels in the human heart.

Pharmacokinetics

Fexofenadine is rapidly absorbed after oral administration, the time to reach the maximum concentration (Tmax.) Is approximately 1-3 hours. The average value of the maximum concentration (Cmax) when taking 120 mg per day is approximately 289 ng / ml, and when taking 180 mg per day - approximately 494 ng / ml.

Fexofenadine is 60-70% bound to plasma proteins.

Fexofenadine is slightly metabolized in and outside the liver, which is confirmed by the fact that it is the only substance detected in significant quantities in the urine and faeces of humans and animals.

With the course of taking the drug, the plasma elimination curve of fexofenadine decreases biexpotentially, and the final half-life is 11-15 hours.

Pharmacokinetics with a single and course administration of fexofenadine (up to 120 mg twice a day by mouth) is linear. A dose of 240 mg twice daily gives a slightly larger than a proportional (8.8%) increase in the area under the concentration-time curve, which indicates that the pharmacokinetics of fexofenadine is almost linear in the dose range from 40 to 240 mg per day.

According to the currently available data, most of the dose taken unchanged is excreted in the bile, and up to 10% of the drug is excreted in the urine.

Indications for use

Seasonal allergic rhinitis (for symptom relief) - 120 mg tablet.

Chronic Idiopathic Urticaria (to reduce symptoms) - 180 mg tablet.

Contraindications

• Hypersensitivity to any component of the drug.

• Pregnancy.

• Lactation period.

• Children's age (up to 12 years old).

Carefully:

- 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, see the section 'Side effects').

Pregnancy and lactation

Pregnancy

There is not enough data on the use of fexofenadine by pregnant women. Limited animal studies have shown no evidence of adverse effects on pregnancy, intrauterine 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 it is taken by breastfeeding women. However, when taking terfenadine, its penetration into the breast milk of lactating women was observed. Therefore, the use of fexofenadine during breastfeeding is not recommended.

Method of administration and dosage

The tablets are intended for oral administration.

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

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

Patients at risk

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.

Side effect

In placebo-controlled clinical trials, the most common (> 1% - <10%) adverse events observed were headache (7.3%), drowsiness (2.3%), dizziness (1.5%) and nausea 1.5 %. With fexofenadine, the incidence of the above adverse effects was similar to that with placebo.

In placebo-controlled studies 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 sleep disturbances or unusual dreams (paroniria), such as nightmares; tachycardia, palpitations; diarrhea.

In rare cases (> 0.01% - <0.1%), exanthema, urticaria, itching and other hypersensitivity reactions such as Quincke's edema, difficulty breathing, shortness of breath, skin hyperemia, systemic anaphylactic reactions were observed.

Overdose

Symptoms

In case of an overdose, dizziness, drowsiness and dry mouth were observed. Healthy volunteers took 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 without any 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 perform gastric lavage, intake of activated charcoal, if necessary, symptomatic and supportive therapy. Hemodialysis is ineffective.

Interaction

With the combined use of fexofenadine with erythromycin or ketoconazole, the plasma concentration of fexofenadine increases 2-3 times, but this is not associated with a significant lengthening of the QTc interval. There were no significant differences in the incidence of adverse effects when these drugs were used alone and in combination. Animal studies have shown that the aforementioned increase in plasma concentrations of fexofenadine is probably associated with an improved absorption of fexofenadine and a decrease in its biliary excretion or secretion into the lumen of the gastrointestinal tract.

There is no interaction between fexofenadine and omeprazole.

Does not interact with drugs 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, apparently, of binding in the gastrointestinal tract.

special instructions

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

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

Effects on ability to drive and perform work requiring concentration

When taking the drug, it is possible to perform work requiring a high concentration of attention and speed of psychomotor reactions (with the exception of patients with a non-standard reaction). Therefore, it is recommended to check the individual reaction to taking fexofenadine before engaging in such activities.

Forms of issue

Film-coated tablets 120 mg and 180 mg.

10 tablets in a PVC / aluminum foil blister. 1 blister with instructions for use is placed in a cardboard box.

Shelf life

3 years.

After the expiration date, the drug cannot be used.

Storage conditions

At a temperature not exceeding 25 ? C.

Keep out of the reach of children!

Conditions of dispensing from pharmacies

Without recipe.