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Country of origin : Taiwan

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oxymetazoline

Nasal spray 0.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Taiwan
GMP approvals
PICS
Manufacturer #20552
The company was established in the 1950s, quality is the main focus of continuous quality improvement programs and extensive efforts to pursue perfection. Throughout the half-century, recognition has been gained from multinational companies all over the world. The company follows straight of the PIC/S GMP standard, starting from raw material quality inspection, and in-process quality control to end product quality assurance, complete sets of quality records are kept for analysis and future reference.

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Oxymetazoline

Oxymetazoline is a topical decongestant. It is sold over-the-counter as a topical decongestant in the form of Oxymetazoline hydrochloride in nasal sprays. Oxymetazoline nasal spray relieves nasal discomfort in colds, allergies, hay fever, provides relief from sinus congestion and pressure. Oxymetazoline as a nasal decongestant narrows the blood vessels in the nasal passages. It has also been approved to treat persistent facial erythema associated with rosacea in adults and its vasoconstricting properties are used to treat nose bleeds and eye redness due to minor irritation. Children under six are not allowed to use and kids age 6-12 are also given these sprays unless recommended by the doctor. Oxymetazoline is sold in many popular brand names around the world such as Otrivin, Afrin, Operil, Dristan, Dimetapp, Oxyspray, Facimin, Nasivin, Nostrilla, Utabon, Sudafed OM, Vicks Sinex, Zicam, SinuFrin, Drixoral, and Mucinex Full Force. Fruhstorfer of E. Merck Darmstadt developed Oxymetazoline in 1961. It was approved in the USA for topical treatment of persistent facial erythema and in 2020, it also received approval from the USFDA for the treatment of acquired drooping eyelid.

Dosage Forms & Strengths

Oxymetazoline is sold as an intranasal solution of 0.05% concentrate. For temporary relief from Nasal Congestion, the patient has to drop 2-3 gtt of the sprays per nostril. This can be repeated every 12 hours, but more than twice, and should not be used for more than 5 days.

The price of Oxymetazoline

In the USA, the consumer has to pay around $10 for nasal spray 0.05% for a supply of 15 milliliters. This medicine is significantly cheaper in developing countries. In India, the 10ml supply of spray costs around $1.

How does it work?

Oxymetazoline has direct-acting sympathomimetic activity and is an imidazole derivative. Oxymetazoline activates alpha-2 adrenergic receptors by selectively bindings them. When used nasally or ocular administration, it works by constricting the arterioles in the nose and eye. This results in decreased nasal and conjunctival congestion, providing relief from the symptoms.

Finding Oxymetazoline Manufacturers and Suppliers:

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