Actonel
risedronate sodium
Pharmacologic class: Bisphosphonate
Therapeutic class: Calcium regulator
Pregnancy risk category C
Action
Inhibits osteoclast-mediated bone resorption. Also exerts antiresorptive effect, probably by directly inhibiting mature osteoclast activity or indirectly inhibiting osteoblasts.
Availability
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
Contraindications
• 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
Precautions
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)
Administration
• 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.
See 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)
Interactions
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.
See 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.
See 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.
risedronate
(riss-ed-roe-nate) risedronate,Actonel
(trade name),Atelvia
(trade name)Classification
Therapeutic: bone resorption inhibitorsPharmacologic: biphosphonates
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (effects on serum alkaline phosphatase)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | within days | 30 days | up to 16 mo |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- weakness (most frequent)
Ear, Eye, Nose, Throat
- amblyopia
- conjunctivitis
- dry eyes
- eye pain/inflammation
- tinnitus
Cardiovascular
- chest pain
- edema
Gastrointestinal
- abdominal pain (most frequent)
- diarrhea (most frequent)
- belching
- colitis
- constipation
- dysphagia
- esophagitis
- esophageal cancer
- esophageal ulcer
- gastric ulcer
- nausea
Dermatologic
- rash (most frequent)
Musculoskeletal
- arthralgia (most frequent)
- musculoskeletal pain (most frequent)
- femur fractures
- osteonecrosis (primarily of jaw)
Respiratory
- asthma exacerbation
Miscellaneous
- flu-like syndrome
Interactions
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).Route/Dosage
Availability
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)Implementation
- 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.