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Ketotifen fumarate manufacturers

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Country of origin : Chile

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ketotifen fumarate

Ophthalmic solution 0.025 g / 100 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Chile
GMP approvals
WHO, INVIMA
Manufacturer #18571
The company produces and markets ophthalmologic products exclusively but expanded rapidly to other specialties, trying to obtain the position of one of the leaders within the international pharmaceutical industry. The company aspires to have the values of respect, loyalty, integrity, and responsibility, amongst others, prevail in all of its relationships with workers, authorities, competitors, clients, and the community at large.

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Ketotifen Fumarate Manufacturers

Ketotifen Fumarate is known by the brand name Zaditor. It is used to prevent and treat allergic conjunctivitis (itching of the eyes caused by allergens). It belongs to the drug class of Antihistamines, the Ophthalmic family of medications. It is also a mast cell stabilizer, which reduces the release of natural chemicals that induce allergic reactions. This pharmaceutical medicine can be taken alone or in combination with other drugs. Adults and children aged three and up should only put 1 drop in the damaged eye(s) every 8-12 hours, no more than twice each day. It is unknown whether this drug is safe and effective in children under the age of three. This drug can have major adverse effects such as eye redness, discharge, eyelid swelling, eye pain, visual abnormalities, and extreme itching of the eyes worse than before using the medication. Some of the most common side effects related to this pharmaceutical medicine include moderate eye irritation, eye dryness, and increased light sensitivity. Ketotifen Fumarate is not recommended for anyone who has a known hypersensitivity to any of the ingredients in this medication. This drug is classified as a pregnancy category C agent by the FDA. There have been no sufficient and well-controlled investigations of this medication in pregnant women. It is suggested that pregnant women seek the guidance of a qualified health care practitioner before self-treating with any medication, including this non-prescription antihistamine eye drop. When systemically given Ketotifen is administered to a breastfeeding woman, extreme caution should be observed. This drug has been found in animal breast milk after oral dosing. Ocular administration is unlikely to result in measurable amounts in breast milk.

How does Ketotifen Fumarate work?

Ketotifen is a non-competitive antagonist of H1 histamine receptors, which is thought to contribute significantly to its anti-allergic effect. It stabilizes mast cells and inhibits the release of allergic and inflammatory mediators such as histamine, leukotrienes C4 and D4 (i.e., SRS-A), and platelet-activating factor (PAF).

The cost of Ketotifen Fumarate

1 Bottle, 5ml of 0.025 percent each of the generic Ketotifen Fumarate costs an average of $13.99.

Navigating our pharmaceutical marketplace

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Quality assurance

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