Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RISEDRONATE SODIUM
PYRIDAM FARMA TBK - Indonesia
RISEDRONATE SODIUM
35 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 4 TABLET SALUT SELAPUT
BALKANPHARMA-DUPNITSA AD - Bulgaria
2021-03-28
Actonel Once-a-Week Risedronate sodium 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 mg or 25 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydarte is C7H10NO7P2Na●2.5H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(-3-pyrudinyl) ethyli-dene]bis[phosponic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following: Molecular Weight: Anhydrous: 305.10 Hemi-pentahydrate: 350.13 Risedronat 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 tablets only), ferric oxide yellow (5 & 35 mg tablets only), hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. CLINICAL PHARMACOLOGY Mechanism of Action: ACTONEL has 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: Absorption after an oral dose is relatively rapid (tmax ̴ 1 hour) and occurs throughout the upper gastrointestinal tract. The fraction of the dose absorbed is independent of dose over the range studied (single dose, 2.5 to 30 mg; multiple dose, 2.5 t Prečítajte si celý dokument