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.
| 5 ml | |
| loratadine | 5 mg |
[Ring] glycerol, propylene glycol, sucrose, Sodium benzoate, citric acid monohydrate, cherry flavor “Cherry Flavour”, disodium эdetat, Purified water.
120 ml – vials of dark glass (1) complete with measuring spoon – packs cardboard.
◊ Pills round, lenticular, from white to almost white, with Valium on one side.
| 1 tab. | |
| loratadine | 10 mg |
[Ring] lactose monohydrate, corn starch, Colloidal anhydrous silica, povidone, polysorbate 80, microcrystalline cellulose, krospovydon, talc, magnesium stearate.
10 PC. – blisters (1) – packs cardboard.
◊ Effervescent tablets round, from white to almost white.
| 1 tab. | |
| loratadine | 10 mg |
[Ring] sodium bicarbonate, anhydrous sodium carbonate,, Citric acid anhydrous, povidone, polysorbate 80, Colloidal anhydrous silica, lactose monohydrate, macrogol 6000.
10 PC. – Plastic tubes (1) – packs cardboard.
10 PC. – Plastic tubes (2) – packs cardboard.
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. Cmax loratadine plasma achieved through 1-1.3 no, osnovnogo aktivnogo metabolite, dezkarboэtoksiloratadina, – approximately 2.5 no.
In simultaneous ingestion bioavailability of loratadine and dezkarboetoksiloratadina increased by about 40% and 15% respectively, the time to reach Cmax It increased by approximately 1 no, its values for these substances remained unchanged.
Plasma protein binding of loratadine high – about 98%, aktivnogo metabolite – less pronounced.
The average T1/2 loratadine is 8.4 no, dezkarboэtoksiloratadina – 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% – the urine within the first day.
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: rarely – dry mouth, nausea, vomiting, gastritis; in some cases – abnormal liver function.
CNS: rarely – fatigue, headache, excitability (children).
Cardio-vascular system: rarely – tachycardia.
Allergic reactions: rarely – skin rash; in a few cases – anaphylactic reactions.
Dermatological reactions: in some cases – alopecia.
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.
