Each uniquely formulated sustained release Oradin Plus^® tablet contains loratadine USP 10 mg for immediate release and pseudoephedrine hydrochloride USP 240 mg which is released slowly allowing for once daily administration. Loratadine is selective peripheral histamine H1 receptor antagonist. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine, which exerts a decongestant action on the nasal mucosa.

Oradin Plus^® tablets are indicated for the relief of nasal and non-nasal symptoms of various allergic conditions such as seasonal and perennial allergic rhinitis. Oradin Plus^® tablet should be administered when both the antihistaminic property of loratadine and the nasal decongestant activity of pseudoephedrine hydrochloride are desired. Oradin Plus^® is used for the temporary relief of runny nose, sneezing and nasal stuffiness from the common cold. It may be used in bronchitis or pharyngitis and for inflamed and congested sinuses (sinusitis)

Adults and children over 12 years of age: One tablet daily.
As Oradin Plus^® contains pseudoephedrine hydrochloride which may cause agitation and insomnia as side effects, it is best recommended that pseudoephedrine hydrochloride should be administered in once daily formulation and be taken in the morning instead of night.
 

This product is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to either components of this combination. Pseudoephedrine hydrochloride is contraindicated in patients with narrow angle glaucoma or urinary retention. It is also contraindicated in patients with severe hypertension, severe coronary artery disease. Loratadine and pseudoephedrine hydrochloride combination should not be taken at the same time or within 14 days of taking monoamine oxidase (MAO) inhibiting drugs.

Pregnancy: Pregnancy category B. There was no evidence of animal teratogenicity in reproduction studies. Loratadine and pseudoephedrine hydrochloride combination tablets should be used during pregnancy only if clearly needed.
Lactation: It is not known if this combination product is excreted in human milk. However, both loratadine and pseudoephedrine hydrochloride when administered alone passes into breast milk, therefore a decision should be made whether to discontinue lactation or to discontinue Oradin Plus^®, taking into account the importance of the drug to the mother.
 

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

Loratadine and pseudoephedrine hydrochloride combination tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraoccular 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. It should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (one tablet every other day) because they have reduced clearance of loratadine and pseudoephedrine.

No specific interaction study has been conducted with loratadine and pseudoephedrine hydrochloride sustained release tablet. However, loratadine (10 mg once daily) has been safely coadministered with therapeutic doses of Erythromycin, Cimetidine and Ketoconazole.

In general loratadine and pseudoephedrine hydrochloride tablet is well tolerated. Clinical trial suggests a very low rate of adverse effects associated with its administration. Among the very few adverse effects, commonly reported are difficulty in sleeping, dry mouth, mild stomach upset, headache, nervousness, dizziness and loss of appetite or thirst. These effects subside as the body adjusts to this medication.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Oradin Plus^® tablet : Box containing 4 strips of 10 tablets each. Each film coated sustained release tablet contains loratadine USP 10 mg as immediate release and pseudoephedrine hydrochloride USP 240 mg as sustained release



Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK