Oradin FT 10 mg - 10's Strip Tablet

Summary:

Indications of Oradin FT 10 mg
Oradin FT 10 mg 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.
Oradin FT 10 mg 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 sign and symptoms are relieved rapidly after oral administration. Oradin FT 10 mg tablet is also indicated in idiopathic urticaria.
In children over 2 years Oradin FT 10 mg tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Theropeutic Class
Non-sedating antihistamines
Pharmacology
Oradin FT 10 mg is a tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity.
It is devoid of anticholinergic activity. It is rapidly effective and long-lasting, allowing once-a-day administration.
Dosage and Administration of Oradin FT 10 mg
Adults and children (6 years of age and over): 10 mg
daily (1 tablet or 2 teaspoonfuls of syrup) once daily.Children ( 2 to 5 years of age): 5 mg (1 teaspoonful syrup) once daily.
Dosage of Oradin FT 10 mg
Adults and children over 12 years of age: One Oradin FT 10 mg 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 Oradin FT 10 mg tablet once daily, below 30 kg: half Oradin FT 10 mg tablet once daily.
Below 2 years of age: Oradin FT 10 mg tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Interaction of Oradin FT 10 mg
There are no reports of potentially hazardous interactions with other drugs.
In contrast to many other histamine H1 receptor antagonists, Oradin FT 10 mg 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 10 mg serum concentrations but no adverse effects are reported.
Contraindications
Oradin FT 10 mg is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
Side Effects of Oradin FT 10 mg
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Oradin FT 10 mg was comparable to that observed with placebo.
Studies on the effect of Oradin FT 10 mg on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
Pregnancy and Lactation
US FDA Pregnancy Category of Oradin FT 10 mg is B. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Oradin FT 10 mg have been shown to be excreted in human milk. So, caution should be exercised when Oradin FT 10 mg is administered to a nursing woman.
Precautions and Warnings
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
Overdose Effects of Oradin FT 10 mg
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.
Storage Conditions
Keep in a dry place away from light and heat. Keep out of the reach of children.
Drug Classes
Non-sedating antihistamines
Mode Of Action
This tablet is a preparation of Oradin FT 10 mg. Oradin FT 10 mg is a non-sedative histamine Hr receptor antagonist with antiallergic properties.
Oradin FT 10 mg 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.
Pregnancy
There is no experience of the use of Oradin FT 10 mg in human pregnancy.
Therefore its use during pregnancy is not advisable.
Oradin FT 10 mg is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.