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

auxiliary substances: sodium benzoate 120 mg, sucrose 72 g (3 g in 5 ml), propylene glycol 13.2 g, glycerol 10.8 g, citric acid anhydrous 1.2 g, vanilla flavor flavor 180 mg, strawberry flavoring 180 mg and water purified to 120 ml.

Description:Pale yellow, a clear, uniform syrup with a characteristic fruity odor, no sediment or mechanical inclusions.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

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

R.06.A.X.13 Loratadin

Pharmacodynamics:Blocker Hl-gistaminovyh receptors (long-acting). Suppresses the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles. The antiallergic effect develops in 30 minutes, reaches a maximum after 8-12 hours and lasts for 24 hours. It does not affect the central nervous system and does not cause addiction (because it does not penetrate the GEB).

Pharmacokinetics:

Quickly and completely absorbed in the gastrointestinal tract. Time to reach the maximum concentration (TCmah) - 1.3-2.5 hours; the intake of food slows it down for 1 hour. The rate in the elderly is increased by 50%, with alcoholic liver damage - with an increase in the severity of the disease.

The connection with plasma proteins is 97%.Metabolized in the liver with the formation of an active metabolite of descarbon ethoxyloratadine with the participation of cytochrome isoenzymes CYP3A4 and to a lesser extent CYP2D6. Css loratadine and metabolite in plasma are achieved by 5 days of administration. It does not penetrate the hemato-encephalic barrier. The half-life of T1 / 2 loratadine is 3-20 hours (on average 8.4), the active metabolite is 8, 8-92 hours (on average 28 hours); in elderly patients, respectively - 6.7-37 hours (an average of 18.2 hours) and 11-38 hours (17.5 hours). With alcoholic liver damage, T1 / 2 increases in proportion to the severity of the disease. It is excreted by the kidneys and with bile.

In patients with CRF and during hemodialysis, pharmacokinetics. practically does not change.

Indications:

Adults

- seasonal and year-round allergic rhinitis;

- allergic conjunctivitis; idiopathic chronic urticaria; itching dermatoses;

- pseudoallergic reactions caused by the release of histamine;

- allergic reactions to insect bites.

Children over 2 years old

- seasonal allergic rhinitis and conjunctivitis;

- allergic skin reactions, for example, idiopathic urticaria.

Contraindications:

- hypersensitivity to the active or any other component of the drug;

- lactation period (see the section "Pregnancy and lactation period");

- Children under 2 years of age (due to lack of clinical data).

Carefully:Severe violations of liver function, renal failure, (glomerular filtration rate of GFR <30 ml / min).

Pregnancy and lactation:The use of Erolin® during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus. The drug is excreted in breast milk, so when taking the drug during lactation should resolve the issue of ending breastfeeding.

Dosing and Administration:

The drug is equipped with a dispensed glass of 5 ml.

Adults and children with a body weight of more than 30 kg - 10 mg (2 cups) 1 time per day.

Children from 2 to 12 years with a body weight of less than 30 kg - 5 mg (1 cup) 1 time per day.

Special patient groups

Patients with hepatic insufficiency or renal insufficiency (GFR <30 ml / min): 5 mg (1 cup) 1 time per day.

Side effects:

Erolyn is usually well tolerated. The frequency of side effects when using the drug is the same as with the use of placebo ("dummy").

Side effects, depending on the individual sensitivity of the patient, are of short duration and completely disappear after the drug is discontinued.

In adults There were: headache, fatigue, dry mouth, drowsiness, gastrointestinal disorders (nausea, gastritis), as well as allergic reactions in the form of rashes. In addition, there were rare reports of anaphylaxis, alopecia, impaired liver function, palpitation, tachycardia.

Children rarely noted: headache, nervousness, sedation. As in adults, the frequency of these events was at the same level as when using a placebo ("dummy").

Overdose:

Symptoms: drowsiness, tachycardia, headache.

Treatment: In case of an overdose, immediately consult a doctor.

Specific antidotes are absent. Supportive and symptomatic therapy. Patients who are conscious should be prescribed emetics. The use of pevecacans is indicated even if spontaneous vomiting occurs. After emptying the stomach should be appointed Activated carbon and large quantities of liquid. If attempts to induce vomiting are unsuccessful, or there are contraindications, the stomach should be washed through the probe. After carrying out urgent measures, patients need medical supervision.

Interaction:

Joint application with erythromycin, cimetidine or ketoconazole leads to an increase in the concentration of loratadine and its metabolites in blood plasma. The concentration of cimetidine and ketoconazole in the blood plasma remains unchanged, while the erythromycin content decreases by 15%.

A sufficient number of safety observations on co-administration with liver enzyme inhibitors (fluconazole, fluoxetine) absent.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) may decrease effectiveness.

Loratadine does not enhance the effect of alcohol on the central nervous system.

Special instructions:

The duration of treatment with Erolin® should be monitored individually.

Patients should be advised to stop taking Erolin® at least 4 days before skin allergic tests are performed to avoid false negative results.

5 ml of syrup contain 3 g of sucrose. A typical daily dose of 10 ml contains 10 mg of sucrose, which should be taken into account when treating patients with diabetes mellitus.Patients with rare hereditary diseases (fructose intolerance and syndrome of impaired glucose absorption / galactose or insufficiency of sucrose / isomaltase).

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

At the beginning of the course of treatment, for an individually defined period of time, driving vehicles and performing work with an increased risk of accidents requires special care because of the risk of side effects such as drowsiness. In the future, the degree of restrictions should be set for each patient individually.

Form release / dosage:Syrup 1 mg / ml.

Packaging:

120 ml in a brown glass vial with a lid with the control of the first autopsy. 1 bottle with a dispensed cup in a cardboard pack together with instructions for use.

Storage conditions:

Store at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package. The open vial should not be stored for more than 6 months if stored.

Terms of leave from pharmacies:Without recipe

Registration number:П N013881 / 02

Date of registration:14.05.2009 / 15.01.2015

The owner of the registration certificate:EGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Manufacturer: & nbsp

EGIS PHARMACEUTICALS, Plc Hungary

Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary

Information update date: & nbsp23.06.2016

Illustrated instructions

Instructions

Erolin® (Erolin®)