Sinuzerc

Each tablet contains: Loratadine 10 mg.

Antihistamine.
Pharmacology: Mechanism of Action: Loratadine is a long-acting antihistamine. It has been characterized as a specific, selective peripheral H₁-receptor antagonist and has been referred to as a relatively "non-sedating" or second-generation antihistamine.
Loratadine diminishes or abolishes the major actions of histamine in the body by competitive, reversible blockade of histamine H₁-receptor sites on tissues; it does not inactivate histamine or prevent its synthesis, nor, in most cases, its release. Histamine H₁-receptors are responsible for vasodilatation, increased capillary permeability, flare and itch reactions in the skin, and to some extent for contraction of smooth muscle in the bronchi and gastrointestinal tract.

Loratadine is used for the symptomatic relief of allergy such as hay fever and urticaria.

Adults and children over 6 years old: 10 mg daily or as prescribed by a physician.

Loratadine is contraindicated in patients who are hypersensitive to the drug or any ingredient in its formulation. The incidence of adverse effects associated with loratadine use generally appears to be less than that associated with the use of first generation (prototypical, sedating) antihistamines, but similar effects have been reported, and the potential for typical adverse effects induced by these agents should be considered during loratadine therapy. Pharmacologic studies indicate that loratadine does not have appreciable anticholinergic effects at doses exceeding those required for antihistaminic activity, and anticholinergic-like effects (e.g., dryness of the nose) either did not occur, or occurred with a frequency similar to placebo, in clinical studies. If the fixed-combination preparation containing loratadine and pseudoephedrine hydrochloride is used, the precautions and contraindications associated with pseudoephedrine must be considered.

Safety and efficacy of the drug in geriatric patients have not been studied specifically to date. Because geriatric patients frequently have decreased renal function (e.g., glomerular filtration), particular attention should be paid to evaluating renal function prior to initiation of loratadine and subsequently thereafter in this age group. If evidence of renal impairment exists or develops, appropriate adjustments in dosage should be made.

Patients with hepatic impairment or renal insufficiency (e.g. glomerular filtration rate less than 30 mL/min), including geriatric patients, have decreased clearance of the drug, and should be given a lower initial dose of loratadine. Because patients with hepatic impairment experience greater decreases in clearance of loratadine than pseudoephedrine, and the doses of loratadine than pseudoephedrine in the fixed-combination preparations cannot be individually adjusted, these preparations generally should not be used in patients with hepatic insufficiency. Patients with renal insufficiency should receive a lower initial dosage of the fixed-combination preparations.

Most commonly reported adverse effects include fatigue, headache, somnolence, dry mouth, gastrointestinal disorders, eg. nausea, gastritis and also allergic symptoms, i.e, rash. Loratadine may cause headache, thirst, blurred vision, dry mouth and dry nose. These effects should subside as the body adjusts to the medication. Loratadine does not usually cause drowsiness when used at recommended doses and under normal circumstances. May discolor urine (this is harmless).

Although increased plasma concentrations (AUC 0-24 hours) of loratadine and descarboethoxyloratadine have been reported when the drug was concomitantly administered with therapeutic dosages of ketoconazole, erythromycin, clarithromycin, or cimetidine in controlled clinical pharmacology studies in healthy individuals, no clinically important changes in ECG or laboratory evaluations, vital signs, or adverse effects were reported. Unlike unchanged terfenadine (no longer commercially available in the US), unchanged loratadine does not appear to be cardiotoxic. No specific drug interaction studies have been conducted with fixed-combination extended-release tablets containing loratadine and pseudoephedrine sulfate. Because monoamine oxidase (MAO) inhibitors potentiate the pressor effects of sympathomimetic drugs (e.g., pseudoephedrine), fixed-combination extended-release tablets containing loratadine and pseudoephedrine are contraindicated in patients receiving an MAO inhibitor, or for 2 weeks after discontinuance of an MAO inhibitor. Loratadine does not affect plasma protein binding of warfarin or digoxin. No apparent increase in adverse effects occurred in individuals receiving oral contraceptives concomitantly with loratadine.

Store at temperatures not exceeding 30°C. Protect from light.

Antihistamines & Antiallergics

R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.

Rx