Tablet, Generic Name: Loratadine INN, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
Encilor tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis, and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching, and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. Encilor tablet is also indicated in idiopathic urticaria. In children over 2 years, Encilor tablet is indicated for the symptomatic relief of seasonal
allergic rhinitis and allergic skin conditions such as urticaria, and nettle rash.
Pharmacology
The tablet is a preparation of loratadine. Loratadine is a non-sedating histamine Hr receptor antagonist with anti-allergic properties. Loratadine is a long-acting tricyclic antihistamine with selective antagonistic activity of peripheral rent receptors, without central sedation or anticholinergic effects. It is fast, effective, and long-lasting, allowing it to be administered once a day.
Dosage & Administration
Adults and children over 12 years of age: One Encilor tablet once daily. It is usually administered in the morning or when symptoms require treatment. Children 2-12 years: Body weight over 30 kg one Encilor tablet once daily, below 30 kg, half Encilor tablet once daily. Encilor tablet is not recommended for use below 2 years of age since safety and efficacy have not been established.
Interaction
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this may result in adverse effects. Cimetidine inhibits both enzymes while erythromycin
or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Contraindications
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
Side Effects
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
Pregnancy & Lactation
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Precautions & Warnings
Patients with impaired liver or kidney function (eGFR <30 ml/min) should proceed with caution.
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.
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