JAPROLOX Patch Ref.[49536] Active ingredients: Loxoprofen

Revision Year: 2019  Publisher: <u>Manufacturer:</u> Lead Chemical Co., Ltd., Hisagane Plant, 327 Hisagane Kamiichi-machi Nakaniikawa-gun, Toyama, Japan <u>Importer and marketing authorization holder:</u> ZUELLIG PHARMA LTD., Bangkok, ...

Product name and form

Japrolox Patch.

Pharmaceutical Form

Loxoprofen sodium water-based patch:

Patch preparation comprising ointment, uniformly spread over a support with the surface of the ointment covered by a liner. The ointment surface is white to pale yellow in color. The ointment has a fragrance of mentha oil.

Qualitative and quantitative composition

Qualitative composition

Generic Name:

Loxoprofen Sodium Hydrate (JAN) / Loxoprofen (INN)

Chemical Name:

Monosodium 2-{4-[(2-oxocyclopentyl) methyl]phenyl} propanoate dihydrate

Molecular Formula:

C15H17NaO32H2O

Molecular Weight: 304.31

Structural Formula:

Description

Loxoprofen sodium hydrate occurs as a white to off-white crystal or crystalline powder. It is very soluble in water and in methanol, freely soluble in ethanol (95) and practically insoluble in diethyl ether. A solution of loxoprofen sodium (1→20) shows no polarization rotation.

Quantitative composition

Loxoprofen sodium water-based patch: A patch containing 113.4mg (100mg as anhydride) of loxoprofen sodium hydrate in 10g of ointment (a sheet of 140 cm²).

Active Ingredient Description
Loxoprofen

Loxoprofen has excellent analgesic, anti-inflammatory and antipyretic properties, with particularly potent pain-relieving activity. This drug is a prodrug which is biotransformed into an active metabolite trans-OH form (SRS coordination) to exert its actions. Inhibition of prostaglandin biosynthesis constitutes the mechanism of action of loxoprofen, the site of action being cyclo-oxygenase.

List of Excipients

Loxoprofen sodium water-based patch:

Mentha oil, polysorbate 80, titanium oxide, tartaric acid, disodium edetate hydrate, concentrated glycerin, carmellose sodium, talc, dried aluminum hydroxide gel, crotamiton, partially neutralized polyacrylate, Starch Grafted Acrylate 300 and Emulsion of Methyl Acrylate and 2-Ethylhexyl Acrylate Copolymer.

Pack sizes and marketing

A light-protective/moisture-proof.

Marketing authorization holder

Manufacturer: Lead Chemical Co., Ltd., Hisagane Plant, 327 Hisagane Kamiichi-machi Nakaniikawa-gun, Toyama, Japan

Importer and marketing authorization holder: ZUELLIG PHARMA LTD., Bangkok, Thailand

Marketing authorization dates and numbers

Refer to outer box and immediate label.

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