Oradin Plus Tablet (Extended Release)

This tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine are desired. This is indicated for the relief of the following symptoms due to hay fever or other upper respiratory allergies:

• nasal congestion
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• swelling of nasal passages
• sinus congestion and pressure

Loratadine is a non-sedative histamine H1-receptor antagonist with anti-allergic properties. Loratadine is a long acting tricyclic anti-histamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anti-cholinergic effect.

Pseudoephedrine is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. This is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. It has nasal and bronchial decongestant activity. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Adults and children over 12 years:

• 5/120 tablet: One tablet twice daily (every 12 hours)
• 10/240 tablet: One tablet once daily and to be taken in the morning instead of night.

Patients with renal insufficiency (GFR<30 ml/min) should be given a lower initial dose (one 5/120 tablet per day, or one 10/240 tablet every alternate day) because they have reduced clearance of Loratadine and Pseudoephedrine.

Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use 10/240 tablet.

Paediatric use: Safety and effectiveness in children below the age of 12 years have not been established.

Use in patients approximately 60 years of age and older: The safety and efficacy of this tablet in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly is more likely to have adverse reactions to sympathomimetic amines.

Loratadine & Pseudoephedrine tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine Sulfate are desired in patients 12 years of age and older.

This tablet is contraindicated in patients taking monoamino oxidase (MAO) inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, reserpine and veaturm alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitantly administration of Erythromycin, Ketoconazole and Cimetidine increases plasma concentration of both Loratadine and Decarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine.

This tablet is contraindicated in patients who are hypersensitive to any component of this product.

In general it is well tolerated. Clinical trial suggests a very low of adverse effects commonly reported is dry mouth, somnolence, insomnia, pharyngitis, dizziness, coughing, fatigue, nausea, nervousness, anorexia, dysmenorrheal 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, micturation frequency etc.

Pregnancy category B: no evidence of risk in human is reported. It is not known if this combination product is excreted in human milk. However, both Loratadine and Pseudoephedrine when administered alone passed into breast milk, so it should not be administered to lactating mothers.

This tablet should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency should be given a lower initial dose because they have reduced clearance of Loratadine and Pseudoephedrine. As because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of Loratadine to a much greater extent than Pseudoephedrine.

This tablet should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or with accompanying hypotension may be produced by sympathomimetic amines.

In the event of overdosage, general symptomatic and supportive measure should be instituted promptly and maintained for as long as necessary. Treatment of overdose would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed with normal saline.

Anti-histamine & decongestant

Store at a cool and dry place, away from light. Keep out of the reach of children.