Pretin D

Tablet

Description Pretin D tablet is a preparation of Loratadine INN and Pseudoephedrine Hydrochloride BP. Each uniquely formulated extended release Pretin D tablet contains 10 mg Loratadine INN for immediate release and 240 mg Pseudoephedrine Hydrochloride BP which is released slowly allowing for once daily administration. Loratadine is selective peripheral histamin H1 receptor antagonist. Pseudoephedrine is an orally active sympathomimetic amine, which exerts a decongestant action on the nasal mucosa. Indications Pretin D is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis. Pretin D tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine are desired in patients 12 years of age and older. Pretin D tablet also temporarily relieves running nose, sneezing; itchy, watery eyes; nasal congestion; itching of the nose or throat due to allergic rhinitis or other upper respiratory allergies; symptoms of common cold; and nasal congestion and sinus pressure associated with sinusitis. Dosage and Administration In adults and children 12 years of age and over : The recommended dose of Pretin D tablet is once daily. As Pretin D contains Pseudoephedrine which may cause agitation and insomnia as side effects, it is best recommended to be taken in the morning instead of night. Contraindications Pretin D tablet is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. This product, due to its Pseudoephedrine component, is contraindicated in patients with narrowangle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen days of stopping such treatment. It is also contraindicated in patients with severe

hypertension, severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to adrenergic agents, or to other drugs of similar chemical structures. Precautions Loratadine/Pseudoephedrine combination tablets should be used with caution in patients with hypertension, diabetes mellitus, ischaemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines. Drug Interactions Pretin D tablet is contraindicated in patients taking MAO inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of adrenergic blocking agents, Methyldopa, Reserpine, and Veratrum alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitant administration of Erythromycin, Ketoconazole, and Cimetidine increased the plasma concentration of both Loratadine and Descarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine. Side Effects In general it is well tolerated. Clinical trials suggest a very low rate of adverse effects associated with its administration. Among the very few adverse effects commonly reported are dry mouth, somnolence, insomnia, pharyngitis, dizziness, cough, fatigue, nausea, nervousness, anorexia, dysmenorrhoea and headache. Other less common side effects may include increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, frequency of micturition etc. Use in Special Populations Geriatric use : The safety and efficacy in patients above 60 years old have not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines.

Pregnancy Category B : No evidence of risk in humans is reported. Lactation : It is not known if this combination product is excreted in human milk. However, both Loratadine and Pseudoephedrine when administered alone passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother. Paediatric use : Safety and effectiveness in children below the age of 12 years have not been established. Commercial Pack PretinD Tablet : Box containing 50 tablets in 5 x 10s blister strips. Each tablet contains Loratadine INN 10 mg and Pseudoephedrine Hydrochloride BP 240 mg .