This tablet is indicated when both the antihistaminic effect of Loratadine and the nasal decongestant action of Pseudoephedrine are required. It is used to relieve the following symptoms associated with hay fever and other upper respiratory allergies:

• nasal blockage
• watery nasal discharge
• frequent sneezing
• itchy and watery eyes
• irritation of the nose or throat
• swelling within the nasal passages
• sinus congestion and pressure

Loratadine is a non-sedating histamine H1-receptor antagonist with anti-allergic properties. It is a long-acting tricyclic antihistamine that selectively blocks peripheral H1 receptors without producing significant central sedation or anticholinergic effects.

Pseudoephedrine is an orally active sympathomimetic amine that acts as a nasal decongestant. It is widely used for the relief of nasal congestion associated with allergic rhinitis and exhibits both nasal and bronchial decongestant activity. Pseudoephedrine functions as both an alpha- and beta-adrenergic receptor agonist. It produces vasoconstriction by directly stimulating alpha-adrenergic receptors in the respiratory mucosa and also stimulates beta-adrenergic receptors, resulting in bronchial relaxation as well as increased heart rate and myocardial 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 and Pseudoephedrine tablets are indicated for patients 12 years of age and older when both the antihistaminic effects of loratadine and the nasal decongestant action of pseudoephedrine sulfate are required.

This tablet is contraindicated in patients who are currently taking monoamine oxidase (MAO) inhibitors or who have discontinued MAO inhibitor therapy within the previous two weeks. Sympathomimetic agents may reduce the antihypertensive effects of beta-adrenergic blockers, methyldopa, reserpine, and veratrum alkaloids. Concomitant use of pseudoephedrine with digitalis may increase ectopic pacemaker activity. Co-administration of erythromycin, ketoconazole, or cimetidine can elevate plasma concentrations of loratadine and its active metabolite, descarboethoxyloratadine; however, no clinically significant changes in the safety profile of loratadine have been observed.

This tablet is contraindicated in patients with known hypersensitivity to any of its components.

In general, this tablet is well tolerated. Clinical trials indicate a low incidence of adverse effects. Commonly reported side effects include dry mouth, somnolence, insomnia, pharyngitis, dizziness, cough, fatigue, nausea, nervousness, anorexia, dysmenorrhea, and headache. Less common adverse effects may include increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, and increased frequency of micturition.

Pregnancy Category B: No evidence of risk in humans has been reported. It is not known whether this combination product is excreted in human breast milk. However, both loratadine and pseudoephedrine are known to pass into breast milk when administered individually; therefore, this medication should not be used by lactating mothers.

This tablet should generally be avoided in patients with hepatic impairment. In patients with renal insufficiency, a lower initial dose is recommended due to reduced clearance of both loratadine and pseudoephedrine. Because this is a fixed-dose combination, the individual components cannot be titrated separately. Moreover, hepatic impairment reduces the clearance of loratadine to a much greater extent than that of pseudoephedrine.

The tablet should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, or renal impairment. Caution is also advised as sympathomimetic amines may produce hypotension in some individuals.

In cases of overdose, general symptomatic and supportive measures should be initiated promptly and continued as required. Management may include induction of emesis with syrup of ipecac, except in patients with impaired consciousness.

This should be followed by administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful or contraindicated, gastric lavage with normal saline should be considered.

Anti-histamine & decongestant.

Store in a cool, dry place protected from light. Keep out of reach of children.