Drug Guide
Risedronate Sodium
Classification
Therapeutic: Bisphosphonate for osteoporosis
Pharmacological: Pyrophosphate analog that inhibits osteoclast-mediated bone resorption
FDA Approved Indications
- Postmenopausal osteoporosis
- Osteoporosis in men
- Paget's disease of bone
Mechanism of Action
Risedronate binds to hydroxyapatite in bone, inhibiting osteoclast-mediated bone resorption, leading to increased bone mineral density.
Dosage and Administration
Adult: Typically 35 mg once weekly or 75 mg once monthly, taken with water on an empty stomach, at least 30 minutes before the first food, beverage, or medication of the day.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustment needed, but renal function should be monitored.
Renal Impairment: Dose adjustment may be necessary in severe impairment; avoid in end-stage renal disease.
Hepatic Impairment: No dosage adjustment indicated.
Pharmacokinetics
Absorption: Poor oral absorption (~0.5-1%), increased when taken on an empty stomach.
Distribution: Extensively binds to bone, minimal plasma protein binding.
Metabolism: Not metabolized.
Excretion: Primarily excreted unchanged via the kidneys.
Half Life: Approximately 2-3 hours in plasma; retained in bone for years.
Contraindications
- Hypocalcemia
- Hypersensitivity to risedronate or other bisphosphonates
- Esophageal abnormalities impairing swallowing
- Inability to sit or stand upright for at least 30 minutes
Precautions
- Renal impairment
- Medication overrides hysterectomy and osteoporosis-related fractures risk
- Caution in gastrointestinal disorders
Adverse Reactions - Common
- Gastrointestinal upset (abdominal pain, dyspepsia, nausea) (Common)
- Musculoskeletal pain (Common)
Adverse Reactions - Serious
- Esophageal ulceration or erosion (Rare)
- Osteonecrosis of the jaw (Very rare)
- Atypical femoral fractures (Rare)
Drug-Drug Interactions
- Calcium, magnesium, aluminum-containing antacids and supplements
- Oral contraceptives containing estrogen
Drug-Food Interactions
- Calcium-rich foods can impair absorption
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor renal function, serum calcium, and symptoms of esophageal irritation.
Diagnoses:
- Risk for falls due to musculoskeletal pain
- Risk for hypocalcemia
Implementation: Advise patients to take the medication with a full glass of water upon waking, remain upright for at least 30 minutes, and avoid food or other medications during this interval.
Evaluation: Assess for improvement in bone density and reduction in fracture incidence.
Patient/Family Teaching
- Take medication as directed, on an empty stomach, with plain water.
- Remain upright for at least 30 minutes after taking to prevent esophageal irritation.
- Report new or worsening heartburn, difficulty swallowing, or jaw pain.
Special Considerations
Black Box Warnings:
- Risk of osteonecrosis of the jaw, primarily after dental surgery or invasive dental procedures.
- Atypical femur fractures associated with long-term use.
Genetic Factors: No specific genetic considerations reported.
Lab Test Interference: May elevate serum calcium and bone turnover markers.
Overdose Management
Signs/Symptoms: Possible hypocalcemia, gastrointestinal irritation.
Treatment: Discontinue drug, provide calcium and vitamin D supplementation, supportive care.
Storage and Handling
Storage: Store at room temperature away from moisture and sunlight.
Stability: Stable until the expiration date on the container.