Remitch Description

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

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Full Prescribing Info

Description

Soft purplish red to dull red film-coated tablet. (See Table 1.)

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Remitch OD tablets 2.5 µg: Each tablet contains 2.5 μg of nalfurafine hydrochloride.
Chemical name: (2E)-N-[(5R, 6R)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-yl]-3-(furan-3-yl)-N-methylprop-2-enamide monohydrochloride.
Molecular formula: C₂₈H₃₂N₂O₅ · HCl.
Molecular weight: 513.03.
Description: Nalfurafine hydrochloride is a white to slightly-yellowish powder. It is very hygroscopic and slightly unstable to light. It is freely soluble in water and methanol, slightly soluble in ethanol (95), and practically insoluble in ethyl acetate and diethyl ether.
Distribution coefficient: 0.95 [1-Octanol/buffer solution of pH 6.8 (LogD)].
Excipients/Inactive Ingredients: D-mannitol, sodium thiosulfate hydrate, crospovidone, magnesium stearate, polyvinyl alcohol (partially hydrolyzed), lactose hydrate, macrogol 400, titanium oxide, red ferric oxide.

Manufacturer:

Bushu Pharmaceuticals

Distributor:

DKSH

Marketer:

Meiji