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

Composition:One tablet contains: active substance - loratadine 0.01 g; Excipients - milk sugar, potato starch, aerosil, magnesium stearic acid, kollidon 25, microcrystalline cellulose.

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 H₁long-acting histamine receptors. Inhibits 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 30 minutes after taking loratadine, reaches a maximum after 8-12 hours and lasts for 24 hours. Loratadin practically does not affect the central nervous system and is not addictive, since it does not penetrate the blood-brain barrier.

Pharmacokinetics:

Loratadine is rapidly and completely absorbed in the gastrointestinal tract. The time to reach the maximum concentration in the blood plasma is 1.3-2.5 hours. Food intake increases the time to reach the maximum concentration by 1 hour.In elderly people, the maximum concentration in the plasma increases by 50%, with alcoholic damage to the liver, the maximum concentration increases with increasing severity of the disease. The connection with proteins is 97%. Loratadin is metabolized in the liver with the formation of an active metabolite of descarbon ethoxyloratadine with the participation of cytochrome p450 isoenzymes CYP3A4 and, to a lesser extent, CYP2D6. The equilibrium concentrations of loratadine and metabolite in plasma are reached on the fifth day of administration. The half-life period varies from 3 to 20 hours (an average of 8.4 hours), 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 from the body with urine and bile. In patients with chronic renal failure and hemodialysis, the pharmacokinetics of loratadine remains virtually unchanged.

Indications:

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

Contraindications:Hypersensitivity.Pregnancy, lactation.

Carefully:

With hepatic insufficiency.

Dosing and Administration:

Inside. Adults and children over 12 years - 10 mg (1 tablet) 1 time per day. The daily dose of 10 mg.

Children aged 2 to 12 years with a body weight of less than 30 kg - 5 mg (1/2 tablets) 1 time per day. The daily dose of 5 mg.

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

With hepatic failure, the initial dose of 5 mg / day.

Side effects:

From the nervous system: anxiety, agitation (in children), asthenia, drowsiness, hyperkinesia, paresthesia, tremor, amnesia, depression, fatigue.

From the skin and subcutaneous fat: dermatitis.

From the genitourinary system: a change in the color of urine, a painful urge to urinate; dysmenorrhea, menorrhagia, vaginitis.

From the side of metabolism: weight gain, sweating, thirst.

From the musculoskeletal system: spasms of calf muscles, arthralgia, myalgia.

From the digestive system: dry mouth, taste change, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis, nausea, vomiting.

From the respiratory system: cough, bronchospasm, dry nasal mucosa, sinusitis.

From the sense organs: impaired vision, conjunctivitis, pain in the eyes and ears.

From the cardiovascular system: decrease or increase of blood pressure, palpitations.

Other: photosensitivity, back pain, chest pain, fever, chills, pain in the mammary glands, blepharospasm, dysphonia.

Overdose:

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

Treatment: induction of vomiting with the application of syrup Ipecacuanas, washing stomach, reception of activated carbon.

Interaction:

Ethanol reduces the effectiveness of loratadine. Erythromycin, cimetidine, ketoconazole when combined with loratadine increase the concentration of loratadine in blood plasma, without causing clinical manifestations and without affecting the ECG.

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

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

During treatment with loratadine, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 0.01 g.

Packaging:

10 tablets in a planar cell package. 1 or 2 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

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

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:P N003834 / 01

Date of registration:16.07.2009 / 05.02.2018

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Loratadin (Loratadine)