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Pregnancy Category: C
ClassificationTherapeutic: bone resorption inhibitors
Prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis.Treatment of Paget's disease in men and women.Treatment of osteoporosis in men.
Inhibits bone resorption by binding to bone hydroxyapatite, which inhibits osteoclast activity.
Reversal of the progression of osteoporosis with decreased fractures and other sequelae.
Reduced bone turnover and resorption; normalization of serum alkaline phosphatase with reduced complications of Paget’s disease.
Absorption: Rapidly but poorly absorbed following oral administration (0.63% bioavailability).
Distribution: 60% of absorbed dose distributes to bone.
Metabolism and Excretion: 40% of absorbed dose is excreted unchanged by kidneys; unabsorbed drug is excreted in feces.
Half-life: Initial—1.5 hr; terminal—220 hr (reflects dissociation from bone).
Time/action profile (effects on serum alkaline phosphatase)
|PO||within days||30 days||up to 16 mo|
Contraindicated in: Hypersensitivity;Hypocalcemia;Abnormalities of the esophagus, which delay esophageal emptying (i.e., strictures, achalasia);Inability to stand/sit upright for at least 30 min; Lactation: Lactation;Severe renal impairment (CCr <30 mL/min).
Use Cautiously in: History of upper GI disorders;Other disturbances of bone or mineral metabolism (correct abnormalities before initiating therapy);Dietary deficiencies (supplemental vitamin D and calcium may be required);Invasive dental procedures, cancer, receiving chemotherapy or corticosteroids, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly fitting dentures (may ↑ risk of jaw osteonecrosis); Obstetric / Pediatric: Safety not established; use in pregnancy only if potential benefit justifies potential risks.
Adverse Reactions/Side Effects
Central nervous system
- weakness (most frequent)
Ear, Eye, Nose, Throat
- dry eyes
- eye pain/inflammation
- chest pain
- abdominal pain (most frequent)
- diarrhea (most frequent)
- esophageal cancer
- esophageal ulcer
- gastric ulcer
- rash (most frequent)
- arthralgia (most frequent)
- musculoskeletal pain (most frequent)
- femur fractures
- osteonecrosis (primarily of jaw)
- asthma exacerbation
- flu-like syndrome
Drug-Drug interactionConcurrent use with NSAIDs or aspirin ↑ risk of GI irritation.Absorption is ↓ by calcium supplements or antacids.Proton pump inhibitors and H2 antagonists may cause a faster release of drug from the delayed-release product that can ↑ drug levels; concurrent use not recommendedFood ↓ absorption (administer at least 30 min before breakfast).
Oral (Adults) Postmenopausal Osteoporosis—5 mg daily; or 35 mg once weekly (immediate- or delayed-release); or 75 mg taken on 2 consecutive days for a total of 2 tablets each month; or 150 mg once monthly. Osteoporosis in Men—35 mg once weekly (immediate-release); Glucocorticoid-induced Osteoporosis—5 mg daily; Paget’s disease—30 mg daily for 2 mo; retreatment may be considered after 2 mo off therapy.
Tablets: 5 mg, 30 mg, 35 mg, 150 mg
Delayed-release tablets (Atelvia): 35 mgIn combination with: calcium carbonate.
- Osteoporosis: Assess patients via bone density study for low bone mass before and periodically during therapy.
- Paget’s disease: Assess for symptoms of Paget’s disease (bone pain, headache, decreased visual and auditory acuity, increased skull size).
- Lab Test Considerations: Osteoporosis: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating alendronate therapy. May cause mild, transient ↑ of calcium and phosphate.
- Paget’s disease: Monitor alkaline phosphatase prior to and periodically during therapy to monitor effectiveness of therapy.
Potential Nursing DiagnosesRisk for injury (Indications)
- Oral: Administer Actonel first thing in the morning with 6–8 oz of water, 30 min prior to other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Administer Atelvia right after breakfast with 4 ounces of water. Tablet should be swallowed whole; do not crush, break, or chew.
- Calcium-, magnesium-, or aluminum-containing agents may interfere with absorption of risedronate and should be taken at a different time of day with food.
- Avoid administering delayed-release product with proton pump inhibitors or H2 antagonists; may allow a faster release and increased drug level.
- Instruct patient on the importance of taking as directed. Risedronate should be taken with 6–8 oz of water (mineral water, orange juice, coffee, and other beverages decrease absorption). If a dose of Actonel 35 is missed, take 1 tablet the morning remembered, then return to the 1 tablet/wk on the originally scheduled day; do not take 2 pills at once. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are more than 7 days away: if both Actonel 75 are missed take 1 the morning remembered and 1 the next morning. If only 1 Actonel 75 tablet is missed: take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 75 mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next month. If 1 or both tablets of Actonel 150 are missed and the next month's scheduled doses are more than 7 days away, take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 150-mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next month. Encourage patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
- Caution patients to remain upright for 30 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation.
- Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D (see ).
- Inform patient that severe musculoskeletal pain may occur within days, months, or years after starting risendronate. Symptoms my resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
- Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
- Advise patient to inform health care professional of risedronate therapy prior to dental surgery.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Reversal of the progression of osteoporosis with decreased fractures and other sequelae. For patients at low risk of fracture, discontinue after 3 to 5 yr of use.
- Decrease in serum alkaline phosphatase and the progression of Paget’s disease.
A trademark for the drug risedronate sodium.