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

Excipients: lactose monohydrate (sugar milk) - 140.0 mg, sodium carboxymethyl starch - 3.0 mg, corn starch 9.2 mg, microcrystalline cellulose - 36.0 mg, magnesium stearate - 1.8 mg.

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

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:

H1-histamine receptor blocker (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 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 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. The equilibrium concentration of loratadine and metabolite in plasma is reached by 5 days 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). At alcoholic liver damage, the half-life period increases in proportion to the severity of the disease. It is excreted by the kidneys and through the intestines. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics practically does not change.

Indications:

Allergic rhinitis (seasonal and year-round), conjunctivitis, hay fever, urticaria (including chronic idiopathic), Quincke's edema, 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 (1/2 tablets) 1 time per 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 undesirable phenomena listed below, when using loratadine, occurred at a frequency of ≥ 2 % and approximately at the same frequency as with the 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.

Children 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 charcoal.

Interaction:

Ethanol reduces the effectiveness of loratadine.

Erythromycin, cimetidine, ketoconazole, when combined with loratadine, increase the concentration of loratadine 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 the 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 10 mg.

Packaging:

For 10, 20, 25, 30, 40, 50 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

10, 20, 25, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate for medicines, sealed with caps screwed on with a first opening control or by a "push-turn" system of polypropylene or polyethylene or polypropylene cans for drugs sealed with lids stretched with the control of the first opening of polyethylene or cans of polypropylene for drugs, sealed with lids pulled with the control of the first opening of high-pressure polyethylene.

One bank or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 contour cell packs together with the instruction for use are placed in a cardboard box(pack) of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

4 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-000019

Date of registration:28.03.2007 / 23.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Loratadin (Loratadine)