Loratadin-Eco - instructions for use, dose, side effects, contraindications

Excipients: sodium benzoate - 0,1 g; propylene glycol - 29,0 g; citric acid monohydrate - 0,5 g; ethanol 95 % (ethanol 95%) - 2,6 g; sorbitol (sorbitol) - 60,0 g; banana flavor MA / 1 139 - 0.3 g; purified water - up to 100 ml.

Description:

Transparent, colorless with a yellowish tinge liquid with a characteristic odor.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

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

R.06.A.X.13 Loratadin

Pharmacodynamics:

Loratadine, the active substance of Loratadine-IVF, is a tricyclic compound with a pronounced antihistamine action and is a selective blocker of peripheral H1-histamine receptors. It has a fast and long-lasting antiallergic effect. The beginning of action - during 30 minutes after taking the drug, the antihistamine effect peaks at 8-12 hours after taking and lasts up to 24 hours.

Loratadine does not penetrate the blood-brain barrier and does not affect the central nervous system. Does not have a clinically significant anticholinergic or sedative effect, that is, it does not cause drowsiness and does not affect the rate of psychomotor reactions when administered at the recommended doses.

The drug Loratadin-IVF does not lead to lengthening of the interval QT on electrocardiography (ECG).

With long-term treatment, there were no clinically significant changes in vital signs, physical examination data, laboratory results, or electrocardiography.

Loratadine does not have a significant selectivity for H2-histamine receptors. It does not inhibit norepinephrine reuptake and has virtually no effect on the cardiovascular system or rhythm driver function.

Pharmacokinetics:

Loratadine is rapidly and well absorbed in the gastrointestinal tract. The time to reach the maximum concentration (T_m_Oh) loratadine in blood plasma- 1-1,5 hour, and its active metabolite desloratadine - 1,5 - 3,7 hours. Food intake increases the time (T_m_Oh) in the blood plasma of loratadine and desloratadine for approximately 1 hour, but does not affect the effectiveness of the drug. Maximum concentration (FROM_m_Oh) in the blood plasma of loratadine and desloratadine does not depend on food intake. In patients with chronic kidney disease (C_m_Oh) and the area under the curve "concentration - time" (AUC) loratadine and its active metabolite are increased in comparison with those in patients with normal renal function.The half-life (T1 / 2) of loratadine and its active metabolite does not differ from those in healthy patients. T1 / 2 increases with alcoholic liver damage (depending on the severity of the disease) and does not change in the presence of chronic renal failure.

Loratadine has a high degree (97-99%), and its active metabolite - a moderate degree (73-76%) of binding to plasma proteins.

Loratadine is metabolized in desloratadine with the participation of cytochrome isoenzyme CYP3A4 and to a lesser extent the isoenzyme system CYP2D6. It is excreted through the kidneys (approximately 40% of the ingested dose) and through the intestine (approximately 42% of the ingested dose) for more than 10 days, mainly as conjugated metabolites. Approximately 27% of the ingested dose is excreted through the kidneys within 24 hours after taking the medication. Less than 1% of the active substance is excreted through the kidneys unchanged for 24 hours after taking the drug.

Bioavailability of loratadine and its active metabolite is dose-dependent character.

The pharmacokinetic profiles of loratadine and its active metabolite in adults and elderly healthy volunteers were comparable.

Period T1/2 loratadine is from 3 to 20 hours (an average of 8.4 hours), desloratadine - from 8.8 to 92 hours (an average of 28 hours); in elderly patients, respectively, from 6.7 to 37 hours (an average of 18.2 hours) and from 11 to 38 hours (an average of 17.5 hours). In alcoholic liver damage, the half-life period increases in proportion to the severity of the disease and does not change with chronic renal failure. Conducting hemodialysis in patients with chronic renal failure does not affect the pharmacokinetics of loratadine and its active metabolite.

Indications:

Seasonal (pollinosis) and all-the-year-round allergic rhinitis and allergic conjunctivitis - elimination of symptoms associated with these diseases: sneezing, itching of the nasal mucosa, rhinorrhea, sensation of itching and burning in the eyes, lacrimation.

Chronic idiopathic urticaria.

Contraindications:

Hypersensitivity to loratadine or any other component of the drug.

Children under 2 years.

Breastfeeding period.

Patients with intolerance to fructose - in connection with the presence of sorbitol, which is part of the syrup.

Carefully:

This drug is dangerous forpatients with liver disease, alcoholism, with craniocerebral trauma or with diseases of the brain, as well as in women during pregnancy and children (over 2 years old).

Pregnancy and lactation:

Safety of the use of loratadine during pregnancy is not established. The use of Loragadin-IVF is possible only after consulting a doctor, if the intended benefit to the mother exceeds the potential risk to the fetus.

Loratadine and its active metabolite are excreted in breast milk, so when prescribing a medication during breastfeeding, the question of stopping breastfeeding should be addressed.

Dosing and Administration:

Inside, regardless of meal time.

Adults, including the elderly and adolescents over 12 years of age, are recommended taking Loratadine-IVF 10 mg (10 ml syrup) once a day.

When using the drug in elderly patients and patients with chronic renal failure, dose adjustment is not required.

Children aged 2 to 12 years, the dose of Loratadin-IVF should be prescribed depending on body weight:

- with a body weight of 30 kg and less - 5 mg (5 ml) of syrup once a day;

- with a body weight of more than 30 kg - 10 mg (10 ml) of syrup 1 time per day.

Adults and children with severe liver dysfunction initial dose should be: the body weight of 30 kg, and less than - 5 mg (5 ml) of syrup through the day, with body weight more than 30 kg - 10 mg (10 ml) through day syrup.

Side effects:

In clinical trials involving children aged 2 to 12 years taking the drug loratadine more often than in the placebo group ("pacifiers"), headache (2.7%), nervousness (2.3%), fatigue (1%).

In adult clinical trials, adverse events observed more often than with placebo occurred in 2% of patients taking loratadine. In adults, loratadine was more frequent than in the placebo group, headache (0.6%), drowsiness (1.2%), increased appetite (0.5%), and insomnia (0.1%). In addition to the post marketing period, there were very rare reports (<1/10 000) of dizziness, fatigue, dry mouth, gastrointestinal disorders (nausea, gastritis), allergic reactions such as rash, anaphylaxis, including angioneurotic edema, alopecia, impaired liver function, palpitations, tachycardia and convulsions.

Overdose:

Symptoms: drowsiness, tachycardia, headache.

In case of an overdose, immediately consult a doctor.

Treatment: symptomatic and supportive therapy. Possible gastric lavage, intake of adsorbents (crushed Activated carbon with water).

Loratadine is not excreted by hemodialysis. After providing emergency care, it is necessary to continue monitoring the patient's condition.

Interaction:

Eating does not affect the effectiveness of loratadine.

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

When co-administration of loratadine with ketoconazole, erythromycin, or cimetidine, an increase in loratadine plasma concentration was noted, but this increase was not clinically significant, including electrocardiography data.

Special instructions:

The drug Loratadin-IVF should be discontinued 48 hours before allergic skin tests are performed, as antihistamines may distort the results of the diagnostic study.

The medicinal preparation Loratadine-ECO syrup contains no more than 2.5% of ethyl alcohol.The maximum daily dose of the drug contains 0.25 mg of ethyl alcohol (in terms of absolute alcohol).

This drug is dangerous for patients with liver disease, alcoholism, with traumatic brain injury or with brain diseases, as well as in women during pregnancy and children (over 2 years old).

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

There was no adverse effect of Loratadin-IVF drug on the ability to drive a car or perform other activities that require increased concentration of attention.

However, in very rare cases, some patients experience drowsiness when taking loratadine. which can affect their ability to drive vehicles and work with mechanisms.

Form release / dosage:

Syrup 1 mg / ml.

Packaging:

For 90 ml, 100 ml, 110 ml, 115 ml, 125 ml in bottles of brown or orange glass, sealed with stoppers, polyethylene and caps screwed from polymer materials or lids made of polymer materials, or aluminum caps with perforations.

For 90 ml, 100 ml in bottles with lids or bottles, cans with means of closing polyethylene terephthalate for medicines.

Each vial, a jar along with instructions for use and a measuring spoon or a measuring cup, or a dosing syringe is placed in a cardboard pack.

Storage conditions:

In the dark place at a temperature of 15 ° C to 25 ° C. Freezing is unacceptable.

Shelf life:

3 years. Do not use after expiry date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-004402

Date of registration:02.08.2017

Expiration Date:02.08.2022

The owner of the registration certificate:ECOLAB, CJSC ECOLAB, CJSC Russia

Manufacturer: & nbsp

ECOLAB, CJSC Russia

Information update date: & nbsp01.09.2017

Illustrated instructions

Instructions

Loratadin-Eco (Loratadine-Eco)