Names and pronunciation
(rih-sed′roh-nate) Actonel, Atelvia
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Drug reference
(rih-sed′roh-nate) Actonel, Atelvia
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Func. class.: Bone resorption inhibitor
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Chem. class.: Bisphosphonate
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Do not confuse: Actonel/Actos
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ACTION: Inhibits bone resorption, absorbs calcium phosphate crystal in bone, and may directly block dissolution of hydroxyapatite crystals of bone
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USES: Paget’s disease; prevention, treatment of osteoporosis in postmeno pausal women; glucocorticoid-induced osteoporosis; osteoporosis in men
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Unlabeled uses: Osteolytic metastases
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CONTRAINDICATIONS: Hyper sensitivity to bisphosphonates, inability to R stand or sit upright for ≥30 min, esopha- geal stricture, achalasia, hypocalcemia Precautions: Pregnancy, breastfeeding, children, renal disease, active upper GI disorders, dental disease, hyperparathy- roidism, infection, vit D deficiency, coag- ulopathy, chemotherapy, asthma
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SIDE EFFECTS CNS: Dizziness, headache, depression, asthenia, dizziness, insomnia, weakness CV: Chest pain, hypertension, atrial fibrillation GI: Abdominal pain, diarrhea, nausea, constipation, esophagitis GU: UTI, renal toxicity, acute renal failure MISC: Rash, UTI, pharyngitis, hypocalce- mia, hypophosphatemia, increase PTH MS: Osteonecrosis of the jaw, severe mus- cle/joint/bone pain, femoral fractures SYST: Angioedema, flulike symptoms
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INTERACTIONS Increase: hypocalcemic effect—loop diuretics Increase: GI irritation—NSAIDs, salicy- lates Increase: osteonecrosis of the jaw—suni- tinib Decrease: absorption of risedronate—alu- minum, calcium, iron, magnesium salts, antacids Decrease: absorption of del rel risedro- nate H2 antagonists, proton pump inhibi- tors, do not use together Decrease: Proton pump inhibitors, avoid concurrent use with delayed-release tablet Drug/Food Decrease: bioavailability—take 1⁄2 hr before food or drinks other than water Drug/Lab Test Decrease: calcium, phosphorus
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DOSAGE AND ROUTES Paget’s disease (Actonel) • Adult: PO 30 mg/day × 2 mo; patients with Paget’s disease should receive calcium and vit D if dietary intake lacking; if relapse occurs, retreatment advised Treatment/prevention of postmenopausal osteoporosis • Adult: PO 5 mg/day or 35 mg/wk or 75 mg/day × 2 consecutive days monthly or 150 mg/mo Glucocorticoid osteoporosis • Adult: PO 5 mg/day Osteoporosis in men • Adult: PO 35 mg/wk Bone metastases (unlabeled) • Adult: PO 35 mg weekly Renal dose • Adult: PO CCr <30 mL/min, avoid use
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Available forms: Tabs 5, 30, 150 mg; tab, weekly 35 mg
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Administer: • For 2 mo to be effective for Paget’s disease • With a full glass of water; patient should be in upright position for 1⁄2 hr; swallow whole; do not crush, break, chew; give del rel tablet in AM after breakfast, only use with food (del rel) • Supplemental calcium and vit D for Paget’s disease if instructed by prescriber • Give daily ≥30 min before meals or give weekly • Store in cool environment, out of di- rect sunlight
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Assess: • Paget’s disease: headache, bone pain, increased head circumference • Osteoporosis: in men or postmeno- pausal women; bone density study before and periodically during treatment • GI adverse effects: nausea, diarrhea, gastric reflux, dyspnea • CV adverse reactions: monitor B/P, dysrrthmias, (tachycardia, bradycardia, atrial fibrillation) • Phosphate, alkaline phosphatase, cal- cium; creatinine, BUN (renal disease) • Hypocalcemia: paresthesia, twitching, la- ryngospasm, Chvostek’s/Trousseau’s signs • Serious skin reactions: angioedema • Dental health: provide antiinfectives for dental extraction; cover with antiinfec- tives before dental extraction • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; do not breastfeed, excretion unknown
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Evaluate: • Therapeutic response: increased bone mass, absence of fractures
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To sit upright for 1⁄2 hr after dose to prevent irritation • To notify prescriber immediately if dif- ficulty swallowing, severe heartburn, or pain in chest • To comply with diet, vitamin/mineral supplements • To maintain good oral hygiene • To notify all health care providers of use • That musculoskeletal pain may occur within a few days/mo after starting but usually resolves; use acetaminophen • To exercise regularly; to avoid alcohol, tobacco • To notify prescriber if pregnancy is suspected or if breastfeeding
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PHARMACOKINETICS Rapidly cleared from circulation, taken up mainly by bones (50%), eliminated primarily through kidneys, absorption decreased by food, terminal half-life 23 hr, delayed release 560 hr
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• Adult: PO 30 mg/day × 2 mo; patients with Paget’s disease should receive calcium and vit D if dietary intake lacking; if relapse occurs, retreatment advised Treatment/prevention of postmenopausal osteoporosis
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• Adult: PO 5 mg/day or 35 mg/wk or 75 mg/day × 2 consecutive days monthly or 150 mg/mo Glucocorticoid osteoporosis
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• Adult: PO 5 mg/day Osteoporosis in men
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• Adult: PO 35 mg/wk Bone metastases (unlabeled)
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• Adult: PO 35 mg weekly Renal dose
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• Adult: PO CCr <30 mL/min, avoid use
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