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Apo-Alendronate (CA), Co Alendronate (CA), Dom-Alendronate (CA), Fosamax, Gen-Alendronate (CA), Ratio-Alendronate (CA), Sandoz Alendronate
Pharmacologic class: Bisphosphonate
Therapeutic class: Bone-resorption inhibitor
Pregnancy risk category C
Impedes bone resorption by inhibiting osteoclast activity, absorbing calcium phosphate crystal in bone, and directly blocking dissolution of hydroxyapatite crystal of bone
Tablets: 5 mg, 10 mg, 35 mg, 40 mg, 70 mg
⊘Indications and dosages
➣ Paget's disease of bone (men and women)
Adults: 40 mg P.O. daily for 6 months
➣ Prevention of osteoporosis in postmenopausal women
Adults: 5 mg P.O. daily or 35 mg P.O. once weekly for up to 7 years
➣ Glucocorticoid-induced osteoporosis in men and women
Adults: 5 mg P.O. daily. For postmenopausal women not receiving estrogen, recommended dosage is 10 mg P.O. once daily.
➣ Treatment of osteoporosis in postmenopausal women; treatment to increase bone mass in men with osteoporosis
Adults: 70-mg tablet or 70 mg oral solution P.O. weekly or 10-mg tablet P.O. daily
• Hypersensitivity to drug or its components
• Esophageal abnormalities such as stricture or achalasia that delay esophageal emptying
• Inability to stand or sit upright for 30 minutes
• Increased risk of aspiration (oral solution)
Use cautiously in:
• Severe renal insufficiency (creatinine clearance less than 35 ml/minute), esophageal disease, GI ulcers, gastritis, osteonecrosis of jaw
• pregnant or breastfeeding patients
• Give with 6 to 8 oz of water 30 minutes before first food, beverage, or medication of day.
• Don't give at bedtime or before patient arises for the day.
• Don't give food, other beverages, or oral drugs for at least 30 minutes after giving tablets.
• Keep patient upright for at least 30 minutes after giving dose to avoid serious esophageal irritation.
• Follow oral solution with at least 60 ml (2 oz) of water to facilitate gastric emptying.
• Be aware that patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
• Be aware that aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) may worsen GI upset. Discuss alternative analgesics with prescriber.
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, acid regurgitation, esophageal ulcer, flatulence, dyspepsia, abdominal distention, dysphagia
GU: urinary tract infection
Metabolic: hypomagnesemia, hypophosphatemia, hypokalemia, fluid overload
Musculoskeletal: bone or muscle pain
Skin: rash, redness, photosensitivity
Other: abnormal taste
Drug-drug.Antacids, calcium supplements: decreased alendronate absorption
NSAIDs, salicylates: increased risk of GI upset
Ranitidine: increased alendronate effect
Drug-diagnostic tests.Calcium, phosphate: decreased levels
Drug-food.Any food, caffeine (as in coffee, tea, cocoa), mineral water, orange juice: decreased drug absorption
• Monitor for signs and symptoms of GI irritation, including ulcers.
• Monitor blood pressure.
• Evaluate blood calcium and phosphate levels.
☞ Tell patient to immediately report serious vomiting, severe chest or abdominal pain, difficulty swallowing, or abdominal swelling.
• Instruct patient to take tablets first thing in the morning on an empty stomach, with 6 to 8 oz of water only.
• Instruct patient to follow oral solution with at least 60 ml (2 oz) of water.
• Tell patient not to lie down, eat, drink, or take other oral medications for 30 minutes after taking dose.
• Advise patient to take only those pain relievers suggested by prescriber. Inform him that some over-the-counter pain medications (such as aspirin and NSAIDs) may worsen drug's adverse effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.
alendronateA biphosphonate used to treat postmenopausal osteoporosis and Paget’s disease of bone. Alendronate reduces vertebral fractures by 48% and other fractures by 21%, increases bone density by 9% and density of the hip bones by 6% over 3 years of therapy.
Nausea, stomach pain, constipation, diarrhoea, bloating, headaches, dizziness, swelling of joints (especially of hands and feet).
Mechanism of action
Marked inhibition of bone resorption by inhibiting osteoclastic activity and number of osteoclasts by reducing recruitment, and increasing apoptosis.