Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RISEDRONATE SODIUM
PYRIDAM FARMA TBK - Indonesia
RISEDRONATE SODIUM
150 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 1 TABLET SALUT SELAPUT
BALKANPHARMA-DUPNITSA AD - Bulgaria
2021-03-28
ACTONEL ONCE-A-MONTH RISEDRONATE SODIUM DESCRIPTION Each Actonel 150 mg tablet contains the equivalent of 150 mg of risedronate sodium. The empirical formula for risedronate sodium is C 7 H 10 NO 7 P 2 Na. The chemical name of risedronate sodium is [1-hydroxy-2-(-3-pyridinyl) ethylidene]bis[phosponic acid] monosodium salt. The chemical structure of risedronate sodium hemi- pentahydrate is the following: Molecular weight: 305.10 The CAS registry number is 115436-72-1 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. Each Actonel 150 mg tablet contain risedronate sodium,crospovidone, magnesium stearate, microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, macrogol 4000, macrogol 8000, silicon dioxide, indigo carmine and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACOLOGY Risedronate is a potent pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast- mediated bone resorption. Risedronate is a third generation bisphosphonate. In preclinical studies risedronate sodium demonstrated potent anti-osteoclast and antiresorptive activity, increasing bone mass and biomechanical strength dose-dependently. The activity of risedronate was confirmed by bone marker measurements during pharmacodynamic and clinical studies. With 5 mg risedronate 5 mg daily, decreases in biochemical markers of bone turnover were observed withhin 1 month of treatment and reached a maximum decrease in 3-6 months, remaining stable during the course of therapy. This data demonstrates that risedronate causes a moderate reduction in bone resorption and bone turnover. The new steady state approximates the rate of bone turnover were similar with risedronate 35 mg Once-a-Week and risedronate 5 mg daily. In a study in men with osteoporosis, decreases in biochemical markers of bone turnover were observed at the earliest time point of 3 months and continued to be observed at 24 months. _COMP Les hele dokumentet