Orinex 5 mg Tablet

Orinex 5 mg Tablet

DESCRIPTION

ORINEX (Desloratadine) is a potent, rapidly effective, long-acting, non-sedative antihistamine with selective Histamine H1 receptor antagonist activity.

COMPOSITION

Each film-coated tablet contains Desloratadine INN 5 mg.

INDICATIONS

• Allergic Rhinitis : Orinex is indicated for the relief of the nasal and nonnasal symptoms of allergic rhinitis (Seasonal and perennial).

• Chronic Idiopathic Urticaria : Orinex is indicated for symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients with chronic idiopathic urticaria.

DOSAGE AND ADMINISTRATION

Adult & age over 12 years :

One tablet (5 mg) once daily

Children 6-12 years :

2.5 mg (half of one 5 mg tablet) once daily Patients with liver or renal impairment a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

In general it is well tolerated. Among the very few side effects commonly reported by small percentage of patients are dry mouth, fatigue, myalgia, and somnolence. Less common side effects may include headache, nausea, dizziness, dyspepsia, pharyngitis etc.

GERIATRIC USE

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

PEDIATRIC USE

The safety and effectiveness of Desloratadine in pediatric patients under 6 months of age have not been established.

CONTRAINDICATIONS

Desloratadine is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to Loratadine.

USE IN PREGNANCY & LACTATION

Pregnancy Category C : Desloratadine should be used during pregnancy only if clearly needed.

Nursing Mothers : Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

DRUG

INTERACTION

Concomitant administration of Erythromycin, Ketoconazole, Azithromycin,

Fluoxetine and Cimetidine with Desloratadine increased the plasma concentration of Desloratadine. But there were no clinically relevant changes in the safety profile of Desloratadine.

OVERDOSAGE

No clinically relevant adverse events were reported. In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3- hydroxydesloratadine are not eliminated by hemodialysis.

SUPPLY

Each box contains 10 x 10 tablets in blister strips