Oradin FT

This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.

 

Adults and children over 12 years of age: One Loratadine 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 Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.

There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Oradin FT 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 mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase Oradin FT serum concentrations but no adverse effects are reported.

 

Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

 

During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Oradin FT was comparable to that observed with placebo. Studies on the effect of Oradin FT on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.

 

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.

 

Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).

 

In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.

 

Non-sedating antihistamines

 

Keep in a dry place away from light and heat. Keep out of the reach of children.