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Country of origin : Brazil

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ebastine

Oral solution 1 mg/ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Brazil
GMP approvals
ANVISA
Manufacturer #463

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Ebastine

Ebastine is a low-potential to cause drowsiness, H1 antihistamine, and effective anti-allergic medicine. It relieves symptoms of allergic reactions like hay fever or urticaria or hives. The symptoms of these allergic reactions are sneezing, runny nose, itchy eyes, skin rashes, redness of the eyes. Ebastine does not penetrate the blood-brain barrier to a significant amount. This reduces the combined effectiveness in blocking the H1 receptor in peripheral tissue with a low incidence of central side effects. Thus Ebastine, seldom causing sedation or drowsiness. As a second-generation H1 receptor antagonist, it is mainly for treating allergic rhinitis and chronic idiopathic urticaria. Ebastine is commercialized under different brand names around the world including Ebast, KestineLIO, EstivanLYO among others. Almirall S.A first patented Ebastine in 1983. It came into medical use in 1990. Dosage and administration Ebastine is sold as tablets, fast-dissolving tablets, and syrup. It is available in 10 and 20 mg normal and as fast-dissolving tablets, and a pediatric syrup. The daily dose can vary between 10 or 20 mg, depending on severity. As it has poor water solubility, the substance is given in the micronized form. The standard Oral, Adult dose is 10 mg, taken once a day.

The cost of Ebastine

The consumer has to pay USD 27 for 50 tablets of DT 5mg strength. The retail cost of 50, 10mg tablets is USD52, for the 20 mg variant, the cost is USD 72 for 50 tablets. In India, the cost of 10 tablets is between USD1 to USD 1.5, significantly cheaper than in the USA.

How does Ebastine Work?

Ebastine and its active metabolite is a selective peripheral histamine H1 receptor antagonist. This antagonism in action prevents histamine from attaching to receptors and its activation of receptors of histamine on various tissues gives rise to allergic symptoms like a Runny nose. Ebastine specifically targets Th2-type cytokine production for inhibition. Through this mechanism, it inhibits T cell migration and pro-inflammatory cytokine production by T cells and macrophages. As a piperidine derivative, it has a long-acting effect and is non-sedating. As a second-generation histamine receptor antagonist, it binds preferentially to peripheral H1 receptors. Ebastine has antihistaminic, antiallergic actions to prevent histamine-induced bronchoconstriction.

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