DESCRIPTION
PREVACID® NapraPAC™ 375 is a combination package containing NAPROSYN 375 mg tablets and PREVACID 15 mg capsules. PREVACID® NapraPAC™ 500 is a combination package containing NAPROSYN 500 mg tablets and PREVACID 15 mg capsules.
NAPROSYN
Naproxen is a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAID).
The chemical name for naproxen is (S)-6-methoxy-(alpha)-methyl-2-naphthaleneacetic acid. Its empirical formula is C14H1403 with a molecular weight of 230.26. Naproxen has the following structure:
Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
NAPROSYN tablets contain 250 mg, 375 mg or 500 mg of naproxen (active ingredient) and croscarmellose sodium, iron oxides, povidone and magnesium stearate (inactive ingredients).
PREVACID
The active ingredient in PREVACID capsules is a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. The structural formula is:
Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.
Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25[ordm ]C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.
PREVACID capsules contain enteric-coated granules consisting of lansoprazole (15 mg) [active ingredient], hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, colloidal silicon dioxide, magnesium carbonate, methacrylic acid copolymer, starch, talc, sugar sphere, sucrose, polyethylene glycol, polysorbate 80, and titanium dioxide [inactive ingredients]. Components of the gelatin capsule include gelatin, titanium dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3, and FD&C Red No. 40 [inactiveingredients].
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