PATIENT INFORMATION LEAFLET
INTERNATIONAL NONPROPRIETARY NAME
Description: round, biconvex, blue film-coated tablets with score line on one side.
Film-coated tablet contains
Active ingredient: desloratadine 5 mg.
Excipients: calcium hydrogen phosphate dihydrate, talc, maize starch, microcrystalline cellulose, magnesium stearate.
Coating composition: opadry blue 85F20400 (polyvinyl alcohol, macrogol, titanium dioxide, talc, indigo carmine aluminum lake).
Antihistamines for systemic use. Histamine H1-receptor blocking agent.
PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS
D-Lortin exerts an antihistaminic, antiallergicand anti-inflammatoryaction, without causing drowsiness. Oral desloratadine (the primary active metabolite of loratadine) selectively blocks peripheral histamine H1-receptors. It suppresses cascade of cytostatic reactions: release of proinflammatory cytokines, including interleukine-4 (IL-4), interleukine-6 (IL-6), interleukine-8 (IL-8), interleukine-13 (IL-13), proinflammatory chemokines type RANTES, production of superoxide anions by activated polymorphonuclear neutrophils, eosinophil adhesion and chemotaxis, adhesion molecule expression, including P-selectin, IgE- mediated release of histamine, prostaglandin D2 and leukotriene С4.
The drug is well absorbed from the gastrointestinal tract, peak plasma concentration is achieved in approximately 3 hours. Half-life is about 27 hours. Bioavailability is proportional to the administered dose (doses ranging from 5 mg to 20 mg). It does not cross the blood- brain barrier, crosses the placental barrier and excreted into breast milk.
DOSAGE AND ADMINISTRATION
D-Lortin is taken orally, regardless of meal, in a dose of 5 mg once a day.
Atablet should be swallowed whole, without chewing, and washed down with water.
Increased fatigability, dry mouth, headache.
Very rare - tachycardia, palpitation, increased liver enzyme activity, increased bilirubin concentration, allergic reactions, including anaphylaxis and rash.
INFLUENCE ON ABILITY TO DRIVE AND OPERATE MECHANISMS
D-Lortin does not influence on ability to drive and perform activities requiring high speed of psychomotor reactions.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy due to lack of clinical data on safety administration during pregnancy.
Desloratadine is excreted in breast milk, therefore the use during breastfeeding is contraindicated.
The drug administration is possible only on doctor's prescription.
In studying of drug interaction during multiple co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine, the clinically significant changes of desloratadine concentrations in plasma have not been detected.
Desloratadine does not intensify alcohol action on the central nervous system.
Symptoms: strengthening of side-effects intensity.
Treatment: gastric lavage with following application of activated coal, in case of necessity – symptomatic therapy. Hemodialysis is ineffective. Peritoneal dialysis effectiveness has not been established.
Film-coated tablets. 10 tablets in a blister.
1, 2 or 3 blisters together with a leaflet in a carton box.
Store in a protected from moisture place at temperature not exceeding 25°C. Keep out of reach of children!
3 years from the manufacturing date. Do not use after expiration.
Sold without prescription.
D-LORTIN is a product and a trade mark of "Sanolife", Great Britain.
"WORLD MEDICINE İLAÇ SAN. VE TİC. А.Ş.", TURKEY