Loratadine-HEMOFARM

Active material: Loratadine
When ATH: R06AX13
CCF: Gistaminovыh blocker H₁-receptors. Allergy medication
When CSF: 13.01.01.02
Manufacturer: HEMOFARM KONCERN A.D. (Serbia and Montenegro)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Syrup clear, colorless to slightly yellow, with a fruity odor.

[Ring] glycerol, propylene glycol, sucrose, Sodium benzoate, citric acid monohydrate, ароматизатор вишневый “Cherry Flavour”, disodium эdetat, Purified water.

120 мл – флаконы темного стекла (1) в комплекте с мерной ложкой – пачки картонные.

◊ Pills round, lenticular, from white to almost white, with Valium on one side.

[Ring] lactose monohydrate, corn starch, Colloidal anhydrous silica, povidone, polysorbate 80, microcrystalline cellulose, krospovydon, talc, magnesium stearate.

10 PC. – блистеры (1) – пачки картонные.

◊ Effervescent tablets

[Ring] sodium bicarbonate, anhydrous sodium carbonate,, Citric acid anhydrous, povidone, polysorbate 80, Colloidal anhydrous silica, lactose monohydrate, macrogol 6000.

10 PC. – тубы пластиковые (1) – пачки картонные.
10 PC. – тубы пластиковые (2) – пачки картонные.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

Gistaminovыh blocker H₁-receptors. Has antiallergic, protivozudnoe, antiexudative action. Decreases capillary permeability, prevents the development of edema, It reduces the increased contractile activity of smooth muscle, due to the action of histamine.

Pharmacokinetics

When administered in a therapeutic dose of loratadine is rapidly absorbed from the gastrointestinal tract and almost completely metabolized in the body. C_max loratadine plasma achieved through 1-1.3 no, osnovnogo aktivnogo metabolite, dezkarboэtoksiloratadina, – примерно через 2.5 no.

In simultaneous ingestion bioavailability of loratadine and dezkarboetoksiloratadina increased by about 40% and 15% respectively, the time to reach C_max It increased by approximately 1 no, its values ​​for these substances remained unchanged.

Связывание с белками плазмы лоратадина высокое – около 98%, активного метаболита – менее выраженное.

The average T_1/2 loratadine is 8.4 no, дезкарбоэтоксилоратадина – 28 no (8.8-92 no).

About 80% loratadine is excreted as metabolites in the urine and faeces in equal proportions over the 10 days, about 27% – с мочой в течение первых суток.

Testimony

Seasonal and perennial allergic rhinitis, conjunctivitis, acute urticaria and angioedema, Symptoms gistaminergy, caused by the use gistaminoliberatov (pseudoallergy syndromes), allergic reactions to insect stings, comprehensive treatment of itching dermatoses (contact allergodermatity, chronic eczema).

Dosage regimen

Inside adults and children over 12 years, as well as body weight more 30 kg- 10 mg 1 time / day.

Children from 2 to 12 years with a body weight of less than 30 kg- 5 mg 1 time / day.

Side effect

From the digestive system: редко – сухость во рту, nausea, vomiting, gastritis; в отдельных случаях – нарушения функции печени.

CNS: seldom-fatigue, headache, excitability (children).

Cardio-vascular system: rarely - tachycardia.

Allergic reactions: редко – кожная сыпь; in rare cases - anaphylactic reactions.

Dermatological reactions: в отдельных случаях – алопеция.

Contraindications

Pregnancy, lactation, Children up to age 2 years, hypersensitivity to Loratadine.

Pregnancy and lactation

Loratadine should not be used during pregnancy and lactation.

IN experimental studies Animal loratadine in moderate doses has no adverse effects on the fetus, when administered in high doses, there were some foetotoxic effects.

Cautions

When using loratadine can not completely exclude the development of seizures, especially in predisposed patients.

Patients with impaired renal or hepatic function requires correction mode.

Drug Interactions

In an application with drugs loratadine, which inhibit the isoenzymes CYP3A4 and CYP2D6 or are metabolized in the liver with their participation (incl. cimetidine, Erythromycin, ketoconazole, quinidine, fluconazole, fluoxetine), possible to change the plasma concentration of loratadine and / or these drugs.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, ziksorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce efficiency.