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

Excipients: sugar milk (lactose), povidone (kollidon 25), microcrystalline cellulose, potato starch, silicon dioxide colloid (aerosil), magnesium stearate.

Description:

Tablets of white or almost white color of flat-cylindrical shape with a bevel.

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:

Loratadin is a blocker of H1-histamine receptors (long-acting). Inhibits the release of histamine and leukotriene C4 from mast cells. Prevents development and facilitates the course of allergic reactions. It has anti-allergic, antipruritic and antiexcudative 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 in 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 blood-brain barrier).

Pharmacokinetics:

Quickly and completely absorbed in the gastrointestinal tract. Time to reach the maximum concentration - 1,3-2,5 h; the intake of food slows it down for 1 hour. The maximum concentration in the elderly increases by 50%, with alcoholic damage to the liver in accordance with the increased severity of the disease. The connection with plasma proteins is 97%.Metabolized in the liver with the formation of an active metabolite descarbon ethoxyloratadine with the participation of cytochrome P450 isoenzymes CYP3A4 and to a lesser extent CYP2D6. The equilibrium concentration of loratadine and metabolite in plasma is reached on the 5th day of administration. Does not penetrate the blood-brain barrier. The half-life of loratadine is 3-20 hours (an average of 8.4), the active metabolite is 8.8-92 hours (an average of 28 hours); in elderly patients, respectively, 6.7-37 hours (an average of 18.2 hours) and 11-38 hours (17.5 hours). In alcoholic liver damage, the half-life increases with increasing severity of the disease. It is excreted by the kidneys and with bile. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

Indications:

Seasonal and all-the-year-round allergic rhinitis, conjunctivitis, hay fever, urticaria (including chronic idiopathic), Quincke's edema, allergic itching dermatoses; pseudoallergic reactions caused by the release of histamine, allergic reactions to insect bites.

Contraindications:

Hypersensitivity. Pregnancy, lactation, children up to 3 years.

Carefully:Liver failure.

Dosing and Administration:

Inside.

Adults and children over 12 years: 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg. Children from 3 to 12 years, 5 mg each (1/2 tablets) once a day. The daily dose of 5 mg. Children with a body weight of more than 30 kg - 10 mg of the drug once a day. The daily dose is 10 mg.

Side effects:

The adverse events listed below with loratadine occurred at a frequency of ≥ 2% and approximately at the same frequency as with placebo ("dummies"),

In adults: 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.

Have a detectiveth rarely: headache, nervousness, sedation.

Overdose:

Symptoms: drowsiness, tachycardia, headache. In case of overdose, see a doctor.

Treatment: induction of vomiting, gastric lavage, reception of activated carbon.

Interaction:

Ethanol reduces the effectiveness of loratadine.

Erythromycin, cimetidine, ketoconazole, when combined with loratadine increase the concentrationloratadine in the blood plasma, without causing clinical manifestations and without affecting the ECG.

Inductors of microsomal oxidation (phenytoin, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce effectiveness of loratadine.

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

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 10 mg.

Packaging:

For 10 tablets in a contour mesh box made of PVC film and foil. 1 or 5 contour squares with instructions for use in a pack of cardboard. For 30 tablets in cans of polymeric. Each jar with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, protected from light place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001833/08

Date of registration:17.03.2008 / 02.10.2017

Expiration Date:Unlimited

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

Manufacturer: & nbsp

ROSLEKS PHARM, LLC Russia

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Loratadin (Loratadine)