D-LORTIN

PATIENT INFORMATION LEAFLET

D-LORTIN

TRADE NAME
D-Lortin

INTERNATIONAL NONPROPRIETARY NAME
Desloratadine

PHARMACEUTICAL FORM
Film-coated tablets.
Description: round, biconvex, blue film-coated tablets with score line on one side.

COMPOSITION
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).

ATCCODE                        R06AX27

PHARMACOTHERAPEUTIC GROUP
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.
PHARMACOKINETICS
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.

THERAPEUTIC INDICATIONS

1. seasonal pollinosis and perennial allergic rhinitis (elimination or relief of sneezing, nasal itching and discharge, nasal congestion, eye itching and redness, lacrimation, itchy palate);
2. chronic idiopathic urticaria (decrease and elimination of skin itching and rash).

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.

CONTRAINDICATIONS

1. hypersensitivity to the drug components;
2. pregnancy and lactation period.

SIDE EFFECTS
Increased fatigability, dry mouth, headache.
Very rare - tachycardia, palpitation, increased liver enzyme activity, increased bilirubin concentration, allergic reactions, including anaphylaxis and rash.