Elisei - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrogen phosphate dihydrate 0.009 g microcrystalline cellulose and 102 0.0037 101 g and 0.002 g, 0.0343 g of lactose monohydrate, corn starch 0.0443 g, 0.0007 g of Hypromellose, magnesium stearate 0.001 g Opadry (Opadry II 85F 30571 Blue) 0.005 g.

Description:

Round, biconvex tablets, covered with a film shell of blue color. On the fracture core from almost white to cream color.

Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.27 Desloratadine

Pharmacodynamics:

Desloratadine is a long-acting antihistamine. It is the primary active metabolite of loratadine. Inhibits the cascade of allergic inflammation, including release of pro-inflammatory cytokines including the interleukins IL-4, IL-6, IL-8, IL-13, the release of proinflammatory chemokines (RANTES), the production of superoxide anion by activated polymorphonuclear neutrophils adhesion and chemotaxis eosinophils, isolation of adhesion molecules,such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.

The drug has no effect on the central nervous system, has practically no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions. Does not cause lengthening of the interval QT on the ECG.

The drug begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics:

The concentration of desloratadine in the blood plasma can be determined 30 minutes after the administration. Desloratadine well absorbed, the maximum concentration is achieved on average after 3 hours. Does not penetrate the blood-brain barrier. The bioavailability of desloratadine was proportional to the dose in the range of 5 to 20 mg. The connection with plasma proteins is 83-87%. When applying a dose of desloratadine (from 5 to 20 mg) once a day for 14 days, there are no signs of clinically significant cumulation of the drug.Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine when administered at a dose of 7.5 mg 1 time per day.

Desloratadine is not an inhibitor CYP3A4 and CYP2D4 and is not a substrate or an inhibitor of P-glycoprotein. Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide. Only a small part of the dose taken internally is excreted by the kidneys (<2%) and through the intestine (<7%). Half-life is 20-30 hours (on average - 27 hours).

Indications:

Elimination of symptoms associated with the following conditions:

- allergic rhinitis (sneezing, discharge from the nose, itching, nasal congestion, itching and redness of the eyes, lacrimation, itching in the palate);

- urticaria (itching, rash).

Contraindications:

- Hypersensitivity to the active and / or any auxiliary substance of the drug;

- Pregnancy;

- the period of breastfeeding;

- age up to 12 years (efficiency and safety not established);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:Severe kidney failure.

Pregnancy and lactation:

The use of the drug in pregnancy is contraindicated due to the lack of clinical data on the safety of the drug Elisei during pregnancy.

Desloratadine, the active substance, is excreted in breast milk, so the use of the drug Elisei during breastfeeding is contraindicated.

Dosing and Administration:

Method of application - inside.

Adults and children from the age of 12 the drug is prescribed in a dose of 5 mg (1 tablet) 1 time per day, regardless of food intake. The drug should be taken at the same time of day. The tablet should be swallowed whole, not liquid, squeezed a little water.

The duration of treatment depends on the severity and course of the disease.

Treatment of intermittent allergic rhinitis (the presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the history of the patient: stop after the disappearance of symptoms and resume after their re-occurrence.

With persistent allergic rhinitis (the presence of symptoms more than 4 days a week or more than 4 weeks) it is necessary to continue treatment during the entire period of contact with the allergen.

Side effects:

Usually desloratadine well tolerated, but sometimes there may be side effects. The most common side effects are fatigue, dryness of the oral mucosa and headache.

Mental disorders: hallucinations.

From the nervous system: headache, dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

From the heart: tachycardia, palpitation.

From the gastrointestinal tract: dryness of the oral mucosa, diarrhea, abdominal pain, nausea, vomiting, indigestion.

From the hepatobiliary system: increased activity of liver enzymes, increased concentrations of bilirubin, hepatitis.

From the musculoskeletal system and connective tissue: myalgia.

Common violations: hypersensitivity reactions (including anaphylaxis, angioedema, dyspnea, itching, rashes and urticaria), increased fatigue.

Overdose:

Symptoms of drug overdose: in clinical studies with the use of doses exceeding the recommended 5-fold, no serious adverse reactions were observed. Possible drowsiness.

Treatment and care: with the occasional ingestion of a large amount of the drug - gastric lavage, the reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis; the effectiveness of its removal by peritoneal dialysis is not established.

Interaction:

Clinically significant changes in the plasma concentration of the drug with repeated use with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine were not detected.

Due to the fact that the enzyme responsible for the metabolism of desloratadine is not established, the probability of interaction with other drugs can not be completely ruled out.

In clinical and pharmacological studies desloratadine, which was received together with alcohol, did not increase the negative effect of ethanol on the psychomotor function.

Special instructions:

In patients with renal insufficiency of high degree, the drug Elisei should be administered under the supervision of a doctor.

Patients with rare hereditary manifestations of intolerance to galactose,deficiency of lactase or syndrome of malabsorption of glucose and galactose, the drug is contraindicated.

Children

The effectiveness and safety of the Elisei tablets for children under 12 years of age have not been established.

Effect on the ability to drive transp. cf. and fur:

Patients should be informed that in very rare cases, some people experience drowsiness, dizziness, which can affect their ability to drive and complex equipment.

Form release / dosage:Tablets, film-coated, 5 mg.

Packaging:

For 10 or 30 tablets in a blister of a film of polyvinyl chloride colorless and aluminum foil printed lacquered.

One blister, along with instructions for medical use, is placed in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002426

Date of registration:08.04.2014

Date of cancellation:2019-04-08

The owner of the registration certificate:FARMAK, JSC FARMAK, JSC Ukraine

Manufacturer: & nbsp

FARMAK, PAO Ukraine

Information update date: & nbsp01.01.2016

Illustrated instructions

Instructions

The Elisei (ELIZEY)