SPL Set ID: 2ffee7e7-bfa0-4933-9baf-7df55080816e

1 drug(s) with this SPL Set ID

Open DailyMed details

Pregabalin PREGABALIN
82.5 mg Extended-release
ADVAGEN PHARMA LTD. FDA Rx Only

Pregabalin extended-release tablets are for oral use and contain pregabalin. Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), polyethylene oxide, carbomer, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc and polyethylene glycol. The 82.5 mg also includes FD&C Blue # 1/Brilliant Blue FCF Aluminum lake, FD&C Blue # 2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/Allura Red AC Aluminum Lake, FD&C Yellow # 5/Tartrazine Aluminum Lake; 165 mg includes iron oxide yellow and iron oxide red; 330 mg includes FD&C Red # 40/Allura Red AC Aluminum Lake and FD&C Yellow # 6/Sunset Yellow FCF Aluminum Lake. "Image Description"

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