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fluorometholone

Eye drops 0.1 %

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bangladesh
GMP approvals
WHO
Manufacturer #21340

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FLUOROMETHOLONE

Fluorometholone is a synthetic glucocorticoid and a corticosteroid. It is used to treat certain eye conditions due to inflammation or injury. Fluorometholone actions relieving symptoms like swelling, redness, and itching. Specifically, it used in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. It is used most commonly in seasonal allergic conjunctivitis and other allergies of the eye. Fluorometholone is sold under the brand name FML, FML Forte, and Flarex among others. Nycomed Gmbh filed for the first patent in the USA in 1999. However, the first patent was filed by Senju Pharmaceutical Co., Ltd with WIPO in 1997 for Aqueous suspension preparations with excellent redispersibility and was assigned the patent in 2001. The current assignee for one of the new patent is Santen Pharmaceutical Co Ltd.

Dosage and Administration.

Fluorometholone is sold as ophthalmic suspension as acetate of 0.1% strength, as an ophthalmic suspension as a base for 0.1% strength and 0.25%, as an ophthalmic ointment of 0.1% strength. In the treatment of Ocular Inflammation, when using the suspension, the has to Instill 1-2 gtt into the affected eye every 6 hours. However, on the first day or two, I can be administered every 2 hours. If using the Forte suspension, the patient has to Instill 1 gtt into the conjunctival sac, 2 to 4 times a day, with an initial dose of 1 gtt, every 4 hours in the first 2 days. if using the ointment, the patient applies 0.5 in the ribbon to the conjunctival sac, between 1-3 times a day, which could be higher in the first two days. the effects of the medicines should be measured after 2 days and should not be discontinued prematurely.

The price of Fluorometholone

In the USA, the consumer has to pay an average retail price of $99.01 for a generic version of the eyedropper of 5ml with 0.1%. In India, the same 0.1% eye dropper costs between USD 0.52 and USD1.25.

How does it work?

Fluorometholone is a synthetic glucocorticoid. It has both anti-inflammatory and anti-allergic properties. Fluorometholone works by interacting with cytoplasmic glucocorticoid receptors, which results in activation of glucocorticoid receptor-mediated gene expression. Certain anti- inflammatory proteins are synthesized while inhibiting the synthesis of inflammatory mediators. The eventual result is an overall reduction in chronic inflammation and autoimmune reactions. While there is no clear answer on how ocular corticosteroids work but it has been theorized that they act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins.

Finding Fluorometholone Manufacturers and Suppliers:

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