Risedronate

Table of contents

  • Brand Names
  • Drug Combinations
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Actonel; Belgium: Actonel; Bulgaria: Actonel; Cyprus: Actonel; Czech Republic: Actonel, Juverital, Norsed, Nurrid, Risedronat, Risendros, Tevanel; Denmark: Actonel, Risedronatnatrium, Riseratio; Estonia: Actonel, Azromite, Norifaz, Ribidron, Risedronate, Risendros, Risonate; Finland: Risedronat, Riseos, Riseratio; France: Actonel; Germany: Actonel; Greece: Actonel, Bondapen, Risedronate; Hungary: Risedronat, Risedronate; Ireland: Actonel, Risonate; Italy: Actonel, Avestra; Latvia: Actonel, Azromite, Norifaz, Ribidron, Risedronate, Risendros, Risonate; Lithuania: Actonel, Norifaz, Ribidron, Risedronate, Risendros, Risonate; Luxembourg: Actonel; Malta: Actonel; Netherlands: Actonel; Poland: Actonel, Juverital, Nofemix, Norifaz, Risedrolex, Risedronate, Risendros; Portugal: Actonel, Norifaz, Norsed, Risedronato, Zectoel; Romania: Actonel, Juverital, Lorine, Nurrid, Risedronat, Risendros, Stadronate; Slovakia: Actonel, Bifodron, Juverital, Norifaz, Nurrid, Risedronat, Risendros; Slovenia: Actonel, Risedronat; Spain: Acrel, Actonel; Sweden: Avestra, Fortipan, Norsed; UK: Actonel.

North America

Canada: Actonel; USA: Actonel, Atelvia, Risedronate.

Latin America

Argentina: Actonel, Ductonar, Rentop, Ribastamin, Ridron, Risedon; Brazil: Actonel; Mexico: Actonel, Alesone, Seralis, Teonav.

Asia

Japan: Actonel.

Drug combinations

Risedronate and Calcium Carbonate

Risedronate, Calcium Carbonate, and Cholecalciferol (Vitamin D~3~)

Chemistry

Risedronate Sodium: C~7~H~10~NNaO~7~P~2~. Mw: 305.09. (1) Phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-, monosodium salt; (2) Sodium trihydrogen [1-hydroxy-2-(3-pyridyl)ethylidene]diphosphonate. CAS-115436-72-1 (1990).

Pharmacologic Category

Bone Resorption Inhibitors; Bisphosphonate Derivative. (ATC-Code: M05BA07).

Mechanism of action

Inhibits bone resorption via actions on osteoclasts or on osteoclast precursors. Decreases rate of bone resorption, leading to indirect increase in bone mineral density. In Paget’s disease, inhibition of resorption leads to indirect decrease in bone formation.

Therapeutic use

Treatment of Paget’s disease of bone. Treatment and prevention of glucocorticoid-induced osteoporosis. Treatment and prevention of osteoporosis in postmenopausal women. Treatment of osteoporosis in men.

Pregnancy and lactiation implications

Teratogenic and nonteratogenic embryo/fetal effects reported in animal studies. There are no adequate, well-controlled studies in pregnant women. Theoretically, there may be risk of fetal harm when pregnancy follows completion of therapy. Not recommended in nursing women.

Unlabeled use

Contraindications

Hypersensitivity to risedronate, bisphosphonates, or any component of the formulation. Hypocalcemia. Inability to stand or sit upright for at least 30 minutes.

Warnings and precautions

Infrequently, severe (and occasionally debilitating) bone, joint, and/or muscle pain reported during treatment. May cause irritation to upper gastrointestinal mucosa. Dysphagia, esophagitis, esophageal or gastric ulcers, esophageal erosions, and esophageal stricture (rare) reported with oral bisphosphonates. Use with caution in dysphagia, esophageal disease, gastritis, duodenitis, or ulcers (may worsen underlying condition). Discontinue if new or worsening symptoms occur. Bisphosphonate therapy associated with osteonecrosis, primarily of jaw (observed mostly in cancer patients, but also in postmenopausal osteoporosis and other diagnoses). Invasive dental procedures should be avoided during treatment. Hypocalcemia must be corrected before initiation of therapy. Use with caution in renal impairment (not recommended in CrCl <30 mL/minute).

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