Pronunciation: al-LEN-droe-nate SO-dee-uhm
- Tablets 5 mg
- Tablets 10 mg
- Tablets 35 mg
- Tablets 40 mg
- Tablets 70 mg
- Oral solution 70 mg (as base)
CO Alendronate (Canada)
Sandoz Alendronate (Canada)
Inhibits bone resorption and increases bone density.
Oral bioavailability is 0.64% (women) and 0.59% (men). Food decreases bioavailability significantly.
Distributes to soft tissues, then rapidly to bone. Vd is at least 28 L (exclusive of bone); about 78% protein bound.
About 50% excreted in urine within 72 h. The t ½ is more than 10 yr.
Special PopulationsRenal Function Impairment
Elimination may be reduced. No dosage adjustment is necessary in those with mild to moderate renal function impairment. Alendronate is not recommended in those with severe renal function impairment (Ccr less than 35 mL/min).
Indications and Usage
Treatment of osteoporosis in postmenopausal women; prevention of osteoporosis in postmenopausal women at risk of developing osteoporosis; increase bone mass in men; treatment of glucocorticoid-induced osteoporosis in men and women; treatment of Paget disease of the bone.
Abnormalities of esophagus that delay esophageal emptying; inability to stand or sit upright for at least 30 min; patients at increased risk of aspiration (oral solution); hypocalcemia; hypersensitivity to any component of product.
Dosage and AdministrationOsteoporosis (Postmenopausal Women)
PO 70 mg once weekly or 10 mg once daily.Adults (prevention)
PO 35 mg once weekly or 5 mg once daily.Osteoporosis (Men)
PO 70 mg once weekly or 10 mg once daily.Glucocorticoid-Induced Osteoporosis
PO 5 mg once daily. For postmenopausal women not receiving estrogen, 10 mg once daily.Paget Disease
PO 40 mg once daily for 6 mo. Re-treatment may be considered for patients who relapse after a 6-mo observation period.
- Administer prescribed dose in the morning at least 30 min before the first food, beverage (other than water), or medication of the day.
- Have patient swallow tablet with a full glass (6 to 8 oz) of plain water and remain sitting or standing for at least 30 min.
- Have patient swallow oral solution directly from bottle, then drink at least 2 oz of plain water and remain standing or sitting for at least 30 min.
- Do not administer tablets or oral solution with any liquid other than plain water. Administration of alendronate with food, medication, juices, mineral water, coffee, or any other beverage will reduce alendronate absorption and efficacy.
Store tablets and oral solution at room temperature (59° to 86°F). Keep tablets in tightly closed container. Protect oral solution from freezing.
Risk of upper GI adverse reactions is increased by concomitant use of aspirin and alendronate doses over 10 mg/day.Calcium supplements, antacids, other cations
Decreased alendronate absorption.Food
Absorption of alendronate is decreased by food.Liquids
Beverages other than water decrease absorption.NSAIDs
Risk of GI irritation may be increased.Ranitidine
Increased alendronate absorption; clinical importance unknown.
Laboratory Test Interactions
None well documented.
Headache (3%); malaise (postmarketing).
Pruritus, rash (occasionally with photosensitivity), severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (postmarketing).
Episcleritis, scleritis, uveitis (postmarketing).
Abdominal pain (7%); acid regurgitation, flatulence (4%); constipation, diarrhea, dyspepsia, nausea (3%); esophageal ulcer (2%); abdominal distention, dysphagia, gastric ulcer, gastritis (1%); duodenal ulcer, esophagitis, esophageal erosion, esophageal stricture or perforation, oropharyngeal ulceration (postmarketing).
Hypersensitivity including urticaria, angioedema (postmarketing).
Asymptomatic, mild, and transient decreases in serum calcium (18%) and phosphate (10%); symptomatic hypocalcemia (postmarketing).
Muscular skeletal pain (4%); muscle cramp (1%); transient myalgia (postmarketing).
MonitorBone mineral density
Ensure that bone mineral density is measured before starting therapy and after 6 to 12 mo of treatment in patient with glucocorticoid-induced osteoporosis.Calcium/Vitamin D
Ensure that patient's daily calcium and vitamin D intake are evaluated before starting therapy and that calcium and/or vitamin D supplementation is being used in patient with inadequate daily intake.Esophageal reaction
Monitor patient for signs or symptoms of esophageal reaction (eg, dysphagia, retrosternal pain, new or worsening heartburn). Discontinue therapy and inform health care provider if noted or suspected.
Category C .
Safety and efficacy not established.
Not recommended for patients with Ccr below 35 mL/min.
Food, beverages other than water, and some medications inhibit absorption. Must be taken first thing in the morning with a full glass of water at least 30 min before any food, beverages, or medications. Must remain sitting or standing for 30 min after taking.
Not recommended for patients with upper GI problems.
Correct before starting alendronate.
Maintain adequate calcium and vitamin D intake during alendronate therapy.
Hypocalcemia, hypophosphatemia, upper GI adverse reactions.
- Advise patient to read patient package insert before starting therapy and to reread the insert each time the medication is renewed.
- Instruct patient to take each dose with plain water the first thing upon arising for the day, at least 30 min before first food, beverage, or medication of day, and to remain in a standing or sitting position for at least 30 min and until after their first food of the day.
- Instruct patient using tablet to swallow tablet whole with a full glass (6 to 8 oz) of plain water. Caution patient not to chew or suck on tablet.
- Instruct patient using oral solution to drink entire contents of bottle and then drink at least ¼ cup (2 oz) of water.
- Caution patient not to take alendronate with any other liquid than plain water. Advise patient that taking alendronate with food, other medications, juices, mineral water, coffee, or any other beverage will reduce the absorption of alendronate and reduce its efficacy.
- Advise patient taking alendronate once a week that if a dose is missed, to take dose the next morning, and then return to taking 1 dose a week as originally scheduled on chosen day. Caution patient not to take 2 doses on the same day to catch up.
- Instruct patient to discontinue therapy and seek medical care if any of the following occur: difficulty swallowing; pain behind breastbone; new or worsening heartburn.
- Advise patient regarding interventions that help prevent osteoporosis: 1,500 mg/day of calcium (diet and supplements); vitamin D supplementation; weight-bearing exercise; reduction of cigarette smoking and excessive alcohol consumption.
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