Drug Guide
Alendronate Sodium
Classification
Therapeutic: Bone resorption inhibitor, Bisphosphonate
Pharmacological: Nitrogen-containing bisphosphonate
FDA Approved Indications
- Treatment and prevention of osteoporosis in postmenopausal women
- Treatment of glucocorticoid-induced osteoporosis in men and women
- Treatment of Paget's disease of bone
Mechanism of Action
Alendronate binds to hydroxyapatite crystals in bone, inhibiting osteoclast-mediated bone resorption, leading to an increase in bone mineral density.
Dosage and Administration
Adult: Typically 70 mg once weekly or 10 mg once daily for osteoporosis; 40 mg once daily for Paget's disease.
Pediatric: Not generally recommended for children.
Geriatric: Use with caution; dosage adjustments usually not necessary but monitor renal function.
Renal Impairment: Use with caution; contraindicated in severe renal impairment (creatinine clearance <35 mL/min).
Hepatic Impairment: No specific dosage adjustment necessary.
Pharmacokinetics
Absorption: Poor oral absorption (~0.5-1%), affected by food and calcium supplements.
Distribution: Widely distributed in bone, minimal in plasma.
Metabolism: Not metabolized.
Excretion: Excreted unchanged in urine.
Half Life: Approximately 10 years in bone tissue.
Contraindications
- Hypocalcemia
- Esophageal abnormalities that delay esophageal emptying
- Inability to sit or stand upright for at least 30 minutes
Precautions
- Renal impairment
- Gastrointestinal disorders
- Dose adjustment in renal impairment
Adverse Reactions - Common
- Gastrointestinal upset (abdominal pain, dyspepsia, nausea) (Common)
- Musculoskeletal pain (Common)
- Headache (Common)
Adverse Reactions - Serious
- Atypical femoral fractures (Rare)
- Osteonecrosis of the jaw (Rare)
- Esophageal irritation, ulcers (Rare)
Drug-Drug Interactions
- Calcium supplements, antacids, magnesium, iron (reduce absorption)
Drug-Food Interactions
- Food delays absorption
Drug-Herb Interactions
- No well-established interactions
Nursing Implications
Assessment: Monitor calcium levels, renal function, and dental health.
Diagnoses:
- Risk for decreased bone density
- Risk for injury related to fractures
Implementation: Administer with water after an empty stomach, at least 30 minutes before the first food or drink of the day. Advise patient to remain upright for at least 30 minutes.
Evaluation: Assess changes in bone density, monitor for adverse effects, evaluate medication adherence.
Patient/Family Teaching
- Take the medication on an empty stomach with a full glass of water.
- Remain upright for at least 30 minutes after taking.
- Report new persistent pain in hip, groin, or thigh.
- Maintain adequate calcium and vitamin D intake.
Special Considerations
Black Box Warnings:
- Esophageal ulceration and damage, risk of osteonecrosis of the jaw, and atypical femoral fractures.
Genetic Factors: No specific genetic considerations known.
Lab Test Interference: May alter calcium and phosphate levels; monitor as appropriate.
Overdose Management
Signs/Symptoms: Severe hypocalcemia, gastrointestinal irritation.
Treatment: Discontinue drug, administer calcium and vitamin D, provide supportive care.
Storage and Handling
Storage: Store at room temperature away from moisture and light.
Stability: Stable when stored properly.