《Actonel (risedronate sodium) Tablet》.pdf

Actonel (risedronate sodium)  Tablet, Film Coated [Procter Gamble Pharmaceuticals, Inc.] DESCRIPTION ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast- mediated bone resorption and modulates bone metabolism. Each ACTONEL tablet for oral administration contains the equivalent of 5, 30, 35, or 75 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C H NO P Na •2.5 H O. The chemical 7 10 7 2 2 name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following: Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients: Crospovidone, ferric oxide red (35 mg and 75 mg tablets only), ferric oxide yellow (5 mg and 35 mg tablets only), hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate (5 mg, 30 mg and 35 mg tablets only), magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. CLINICAL PHARMACOLOGY Mechanism Of Action: ACTONEL has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, ACTONEL inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (e.g., lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that ACTONEL treatment reduces bone turnover (activation frequency, i.e., the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites. Pharmacokinetics: Absorption: