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risedronate sodium

Actonel, Atelvia

Pharmacologic class: Bisphosphonate

Therapeutic class: Calcium regulator

Pregnancy risk category C


Inhibits osteoclast-mediated bone resorption. Also exerts antiresorptive effect, probably by directly inhibiting mature osteoclast activity or indirectly inhibiting osteoblasts.


Tablets: 5 mg, 30 mg, 35 mg, 150 mg

Tablets (delayed-release): 35 mg

Indications and dosages

Prevention of postmenopausal osteoporosis

Adults: 5 mg P.O. daily or 35 mg P.O. weekly (immediate-release)

Treatment of postmenopausal osteoporosis

Adults: 5 mg P.O. daily, or 35 mg P.O. weekly, or 150 mg P.O. monthly (immediate-release). Or, 35 mg P.O. weekly (delayed-release).

Osteoporosis in men

Adults: 35 mg (immediate-release) P.O. weekly

Glucocorticoid-induced osteoporosis

Adults: 5 mg (immediate-release) P.O. daily

Paget's disease

Adults: 30 mg (immediate-release) P.O. daily for 2 months. If indicated, may retreat with same dosage after post-treatment observation period of at least 2 months.

Off-label uses

• Hypercalcemia of malignancy

• Primary hyperparathyroidism


• Hypersensitivity to drug, its components, or other bisphosphonates

• Hypocalcemia

• Inability to stand or sit upright for at least 30 minutes

• Esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia


Use cautiously in:

• hypotension, upper GI disorders, difficulty swallowing

• severe renal impairment with creatinine clearance less than 30 ml/minute (not recommended)

• pregnant or breastfeeding patients

• children (use not indicated)


• Be aware that hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting drug.

• Give immediate-release tablets with 6 to 8 oz of water 30 minutes before first food or beverage of day (other than water).

• Give delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water.

Make sure patient stays upright for at least 30 minutes after taking.

• Be aware that patient with poor dietary intake may need calcium and vitamin D supplements.

• Give calcium, magnesium, or aluminum supplements or antacids at different time of day so they don't interfere with risedronate absorption.

Adverse reactions

CNS: headache, anxiety, depression, dizziness, vertigo, syncope, asthenia

CV: hypertension, vasodilation, angina, chest pain, cardiovascular disorder, peripheral edema

EENT: cataract, conjunctivitis, dry eyes, otitis media, rhinitis, sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, gastroenteritis, colitis, esophageal irritation, dry mouth, anorexia, esophageal stricture or perforation (rare)

GU: urinary tract infection

Hematologic: anemia

Musculoskeletal: bone, back, or joint pain; bone fracture; bursitis; myalgia; arthritis; leg and muscle cramps; jaw osteonecrosis

Respiratory: crackles, cough, bronchitis, pneumonia

Skin: rash, pruritus, ecchymosis, skin cancer

Other: accidental injury, infection, neck pain, flulike symptoms, allergic reactions, neoplasm, hypersensitivity reactions including angioedema (rare)


Drug-drug. Antacids, aspirin, calcium-or magnesium-based supplements or laxatives, iron preparations: decreased risedronate absorption

Nonsteroidal anti-inflammatory drugs, salicylates: increased GI irritation

Drug-diagnostic tests. Bone-imaging diagnostic agents: interference with test agents

Calcium, phosphorus: decreased levels

Drug-food. Any food: decreased drug absorption

Patient monitoring

• Watch for difficulty swallowing and signs and symptoms of esophageal irritation. Discontinue drug if new or worsening symptoms occur.

• Assess skin for unusual findings that may indicate skin cancer.

• Monitor patient for severe bone, joint, or muscle pain; consider discontinuing drug if symptoms are severe

Patient teaching

• Advise patient to read patient information insert before starting therapy.

Stress importance of taking immediate-release tablets with a full glass (6 to 8 oz) of water at least 30 minutes before first food or drink of day and delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water. Tell patient to stay upright for at least 30 minutes afterward.

Instruct patient to stop drug and notify prescriber if difficulty or pain on swallowing, midline chest pain, or severe, persistent heartburn occurs.

• Tell patient that chewing or sucking tablet may cause mouth irritation.

• Tell patient to report signs and symptoms of colitis.

• Advise patient taking calcium-, magnesium-, or aluminum-based supplements or antacids to take them at least 2 hours after risedronate.

• Advise patient to promptly report leg cramps or bone, joint, or jaw pain.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(riss-ed-roe-nate) ,


(trade name),


(trade name)


Therapeutic: bone resorption inhibitors
Pharmacologic: biphosphonates
Pregnancy Category: C


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.

Therapeutic effects

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)

POwithin days30 daysup 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

  • amblyopia
  • conjunctivitis
  • dry eyes
  • eye pain/inflammation
  • tinnitus


  • chest pain
  • edema


  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • belching
  • colitis
  • constipation
  • dysphagia
  • esophagitis
  • esophageal cancer
  • esophageal ulcer
  • gastric ulcer
  • nausea


  • rash (most frequent)


  • arthralgia (most frequent)
  • musculoskeletal pain (most frequent)
  • femur fractures
  • osteonecrosis (primarily of jaw)


  • asthma exacerbation


  • flu-like syndrome


Drug-Drug interaction

Concurrent 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 mg
In combination with: calcium carbonate.

Nursing implications

Nursing assessment

  • 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 Diagnoses

Risk 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • 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.
Drug Guide, © 2015 Farlex and Partners


A trademark for the drug risedronate sodium.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.


Risedronate, see there.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.
References in periodicals archive ?
A dedicated GP sales team will be maintained with the responsibility for supporting GPs and specialists who prescribe primary care products, including Actonel. Actavis will also continue to supply Botox, eye-care products and all other heritage Allergan products.
Fosamax and Actonel are the only oral bisphosphonates approved for use in both men and women.
Half were on alendronate (Fosamax), 27% were on risedronate (Actonel), and the rest were on ibandronate (Boniva) or zoledronic acid (Reclast).
Some common drugs include alendronate, risedronate, pamidronate, strontium ranelate, SERM raloxifene, Fosamax, Boniva and Actonel.
(1) The fractures are associated with long-term use of bisphosphonates, which are sold under the brand names Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, and Zometa.
Alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), zoledronic acid (Reclast).
The authors recommend bisphosphonate (Fosamax, Actonel, Boniva) therapy as the first-line agent for treating osteoporosis in men, with teriparatide (Forteo) suggested as an option for men with severe osteoporosis.
Warner Chilcott said Atelvia is the next generation of its popular osteoporosis drug Actonel, which it acquired when it bought Procter & Gamble Co.'s global branded prescription drug business for $3.1 billion last year.
I've been taking the osteoporosis drug Actonel for five years.
In addition, Fosamax, Actonel and Boniva cause serious trouble because they stay in the bone indefinitely and disrupt the normal bone regeneration process forever!
Disclosures: The study was supported by the Alliance for Better Bone Health--Procter & Gamble Pharmaceuticals and Sanofi-Aventis U.S., which co-promote Actonel. Dr.
Currently available bisphosphonates include alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), etidronate (Didronel), pamidronate (Aredia), tiludronate (Skelid) and zoledronic acid (Reclast, Zometa).