Drug Guide
Calcium Carbonate; Risedronate Sodium
Classification
Therapeutic: Osteoporosis agent
Pharmacological: Bisphosphonate, Mineral supplement
FDA Approved Indications
- Treatment and prevention of osteoporosis in postmenopausal women and men at risk of fractures
- Treatment of glucocorticoid-induced osteoporosis
- Paget's disease of bone
Mechanism of Action
Risedronate inhibits osteoclast-mediated bone resorption, leading to increased bone density. Calcium carbonate provides calcium for bone mineralization.
Dosage and Administration
Adult: Risedronate 35 mg once weekly or 150 mg once monthly; Calcium carbonate as directed for calcium supplementation.
Pediatric: Not approved for pediatric use.
Geriatric: Use with caution; adjust dose based on renal function and tolerability.
Renal Impairment: Adjust dose; not recommended in severe impairment.
Hepatic Impairment: No specific adjustment required.
Pharmacokinetics
Absorption: Risedronate is poorly absorbed (approx. 0.5-1%) and absorption is decreased with food.
Distribution: Widely distributed in bone and tissues.
Metabolism: Not metabolized.
Excretion: Renal excretion; unabsorbed drug excreted in feces.
Half Life: Risedronate half-life in bone estimated at years; in plasma about 0.5-1 hour.
Contraindications
- Hypocalcemia
- Altered esophageal anatomy or motility disorders
- Hypersensitivity
Precautions
- Renal impairment, gastrointestinal disorders, risk of atypical fractures, osteonecrosis of the jaw, pregnancy, and lactation should be considered.
Adverse Reactions - Common
- Gastrointestinal discomfort (abdominal pain, nausea, dyspepsia) (Common)
- Musculoskeletal pain (Common)
Adverse Reactions - Serious
- Osteonecrosis of the jaw (Rare)
- Atypical femur fractures (Rare)
- Esophageal irritation or ulceration (Rare)
Drug-Drug Interactions
- Calcium can interfere with absorption of bisphosphonates if taken together.
- Other medications affecting renal function or causing gastrointestinal irritation.
Drug-Food Interactions
- Taking risedronate with food reduces absorption.
- Calcium and other divalent cations should be taken at least 30 minutes apart from risedronate.
Drug-Herb Interactions
- Potential interactions with herbal products that affect calcium or bone metabolism.
Nursing Implications
Assessment: Assess for hypocalcemia, renal function, esophageal disorders.
Diagnoses:
- Impaired oral mucous membrane integrity, risk of fracture, knowledge deficit.
Implementation: Administer risedronate first thing in the morning with a full glass of water, at least 30 min before food or other medications; instruct patient not to lie down for 30 min.
Evaluation: Monitor for bone density improvements, adverse effects, and patient adherence.
Patient/Family Teaching
- Take medication with a full glass of water on an empty stomach at least 30 min before breakfast.
- Do not lie down or recline for at least 30 min after taking medication.
- Maintain adequate calcium and vitamin D intake.
- Report any new or unusual jaw pain, persistent dysphagia, or severe musculoskeletal pain.
Special Considerations
Black Box Warnings:
- Potential risk of osteonecrosis of the jaw, primarily after dental procedures.
- Atypical femur fractures with long-term use.
Genetic Factors: No specific genetic considerations.
Lab Test Interference: May affect calcium, phosphate, or bone turnover markers.
Overdose Management
Signs/Symptoms: Hypocalcemia, gastrointestinal distress.
Treatment: Discontinue medication, provide calcium and vitamin D supplementation, supportive care.
Storage and Handling
Storage: Store at room temperature, away from moisture and light.
Stability: Stable until expiration date on packaging.