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

Excipients: corn starch - 18.0 mg, magnesium stearate - 1.4 mg, talcum powder -3,5 mg, sodium carboxymethyl starch (sodium starch glycolate) 4.2 mg, silicon colloidal dioxide (aerosil) 2.1 mg, microcrystalline cellulose 20.0 mg, lactose monohydrate (milk sugar) 80.8 mg.

Description:Round tablets of white or almost white color of flat-cylindrical shape with a risk and a facet.

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 is an antihistamine drug - an selective blocker of peripheral H1-histamine receptors. It has a fast and long-lasting antiallergic effect. The onset of action is within 30 minutes after admission. The antihistamine effect peaks at 8-12 hours from the onset of action and lasts more than 24 hours.

Loratadine does not penetrate the blood-brain barrier and has no effect on the central nervous system, does not have anticholinergic and sedative action (drowsiness), does not affect the rate of psychomotor reactions. Reception of loratadine does not lead to lengthening of the interval QT on the ECG.

Pharmacokinetics:

Suction: quickly absorbed in the gastrointestinal tract. The time to reach the maximum concentration in the blood plasma of loratadine is 1.3 h, and its active metabolite desloratadine - 2.5 h.Food intake increases the time to reach the maximum concentration of loratadine and desloratadine by approximately 1 hour. The maximum concentration of loratadine and desloratadine is independent of the intake of food. The maximum concentration increases in elderly patients, patients with chronic renal failure or alcoholic liver damage.

Distribution: binding to plasma proteins - 97 %. The equilibrium concentrations of loratadine and metabolite in plasma are reached on the fifth day of administration.

Does not penetrate the blood-brain barrier.

Metabolism: metabolized in the liver in desloratadine by the cytochrome P450 isoenzyme ZA4 and, to a lesser extent, the cytochrome P450 isoenzyme 2D6.

Excretion: is excreted by the kidneys and with bile. The half-life of loratadine ranges from 3 to 20 hours (an average of 8.4 hours), and desloratadine is 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 39 hours (an average of 17.5 hours). The elimination half-life increases with alcoholic liver damage (depending on the severity of the disease) and does not change with chronic renal failure.

Conducting hemodialysis 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, burning sensation and itching in the eyes, lacrimation;

- chronic idiopathic urticaria;

- skin diseases of allergic origin.

Contraindications:

- Intolerance or hypersensitivity to loratadine or any other component of the drug;

- lactation period (breastfeeding);

- age up to 3 years;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

- Severe liver dysfunction;

- pregnancy.

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Loratadin is excreted in breast milk, so when prescribing the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

The drug is administered inside, regardless of the time of eating.

Adults, including the elderly, and adolescents aged 12 years 10 mg (1 tablet) once a day.

Children aged 3 to 12 years the dose is recommended to be administered depending on the body weight:

- with a body weight of less than 30 kg - 5 mg (1/2 tablets) 1 time per day;

- with a body weight of 30 kg and more - 10 mg (1 tablet) 1 time per day.

Patients with severe impaired liver function it is necessary to prescribe a reduced daily dose of the drug:

adults and children with a body weight of more than 30 kg - 10 mg (1 tablet) every other day; Children with body weight less than 30 kg - 5 mg (1/2 tablet) every other day.

For patients with renal insufficiency the initial dose should be 10 mg (1 tablet) every other day.

Side effects:

Allergic reactions: in adults - skin rash, anaphylaxis.

From the central nervous system: in adults - headache, fatigue, drowsiness, insomnia, dizziness; children - headache, nervousness, sedation.

From the skin: in adults it is alopecia.

From the digestive system: in adults - nausea, gastritis, dry mouth, impaired liver function, increased appetite.

From the cardiovascular system: in adults - palpitation, tachycardia.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: drowsiness, tachycardia, headache. In case of an overdose, immediately consult a doctor.

Treatment: gastric lavage (preferably 0.9% sodium chloride solution), absorption of adsorbents (crushed activated carbon with water), symptomatic therapy.

Loratadine is not excreted by hemodialysis.

Interaction:

Eating does not affect the effectiveness of the drug.

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

With the joint administration of the drug with ketoconazole, erythromycin or cimetidine, there is an increase in the concentration of loratidine and its metabolite in plasma.

Special instructions:

The drug should be stopped at least two days before the skin allergic tests, as Loratadin can influence their results.

Effect on the ability to drive transp. cf. and fur:During treatment, care should be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions due to the risk of drowsiness.

Form release / dosage:

Tablets 10 mg.

Packaging:

7 or 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

7, 10, 14, 20, 21, 30 tablets in a polymer can.

Each bank or 1, 2, 3 contour cellular packs with instructions for use in a pack of cardboard.

Storage conditions:

In the 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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002333

Date of registration:18.12.2013 / 15.02.2016

Expiration Date:18.12.2018

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Loratadin (Loratadine)