Alendronate sodium

(ay- LEN - d ro h -n ayt)

CLASSIFICATION(S): Bone growth regulator, bisphosphonate PREGNANCY CATEGORY: C Rx: Fosamax.
USES Daily dosing: (1) Prevent osteoporosis in women who are at risk of developing osteoporosis and to maintain bone mass and reduce the risk of future fracture. (2) Treat osteoporosis in postmenopausal women to increase bone mass and reduce the incidence of fractures, including those of the hip and spine. (3) Increase bone mass in men with osteoporosis. (4) Glucocorticoid-induced osteoporosis in men and women receiving daily dosage equivalent to prednisone 7.5 mg or greater and who have low bone mineral density. Used with adequate amounts of calcium and Vitamin D. (5) Pagets disease of bone in men and women with alkaline phosphatase at least two times the upper limit of normal, for those who are symptomatic, or those at risk for future complications from the disease. Weekly dosing: Treatment or prevention of postmenopausal osteoporosis in women or osteoporosis in men. ACTION/KINETICS Action Binds to bone hydroxyapatite and inhibits osteoclast activity, thereby preventing bone resorption. Appears to reduce fracture risk and reverse the progression of osteoporosis. Does not inhibit bone mineralization. Pharmacokinetics Well absorbed orally and initially distributed to soft tissues, but then quickly redistributed to bone. Not metabolized; 1 excreted through the urine. t /2, terminal: Believed to be more than 10 years, due to slow release from the skeleton. CONTRAINDICATIONS In hypocalcemia. Severe renal insufficiency (CCR less than 35 mL/min). Use of

hormone replacement therapy with alendronate for osteoporosis in postmenopausal women. Use of the PO solution in clients at increased risk of aspiration. Lactation. SPECIAL CONCERNS Use with caution in those with upper GI problems, such as dysphagia, symptomatic esophageal diseases, gastritis, duodenitis, or ulcers. Safety and effectiveness have not been determined in children. Some elderly clients may be more sensitive to the drug effects. Rarely, visual and auditory hallucinations when client switched from daily to weekly use of alendronate. SIDE EFFECTS Most Common Abdominal pain, dyspepsia, nausea, constipation, diarrhea. GI: Flatulence, acid regurgitation, esophageal ulcer, dysphagia, abdominal pain/distention, gastritis, constipation, diarrhea, dyspepsia, N&V. Miscellaneous: Musculoskeletal/back pain, pain, headache, taste perversion, rash and erythema (rare), glaucoma, accidental injury, edema, flulike symptoms, osteonecrosis of the jaw. LABORATORY TEST CONSIDERATIONS Serum calcium and phosphate. OD OVERDOSE MANAGEMENT Symptoms: Hypocalcemia, hypophosphatemia, upset stomach, heartburn, esophagitis, gastritis, ulcer. Treatment: Consider giving milk or antacids to bind the drug. DRUG INTERACTIONS Antacids / Absorption of alendronate Aspirin / Risk of GI side effects Calcium supplements / Absorption of alendronate Naproxen / Risk of drug-induced gastric ulcers Ranitidine / Bioavailability of alendronate (significance not known) HOW SUPPLIED Oral Solution: 70 mg as base (0.93 mg/mL); Tablets: 5 mg, 10 mg, 35 mg, 40 mg, 70 mg. DOSAGE ORAL SOLUTION; TABLETS Prevention of osteoporosis in postmenopausal women.
IV = Intravenous

C = see color insert

H = Herbal

E = sound alike drug

ALENDRONATE SODIUM
6. Store tablets and oral solution in a tight container from 1530 C (5986 F). Do not freeze oral solution. ASSESSMENT 1. Note reasons for therapy: osteoporosis prevention/treatment in postmenopausal women, steroid-induced osteoporosis, or Pagets disease. Note symptoms, onset, physical changes. 2. Obtain baseline VS, height, calcium, phosphate, electrolytes, renal and LFTs; correct any calcium or vitamin D deficiencies, replace and monitor periodically. 3. Note any history of GI problems (i.e., gastritis, dysphagia, duodenitis, or ulcers). Assess for any S&S of esophageal reaction (eg, dysphagia, retrosternal pain, new/worsening reflux); precludes therapy. 4. Document bone mineral density (BMD) studies before starting therapy and after 612 mo of treatment esp. with glucocorticoid induced disease. 5. Assess for fractures; manage to prevent further injury and loss of function. 6. With Pagets disease, monitor baseline S&S and alkaline phosphatase. CLIENT/FAMILY TEACHING 1. Osteoporosis usually occurs after age 40 and is a systemic skeletal disease characterized by low bone mass due to a higher amount of bone resorbed than formed; may be induced by chronic steroid therapy at any age. 2. Take as prescribed. Benefit seen only when each tablet is taken with 68 oz of plain water first thing in the morning at least 30 min before the first food, beverage, or medication of the day. Do not lie down after taking drug. Taking with juice or coffee will markedly reduce absorption. 3. Once weekly therapy may enhance compliance. If taking alendronate once weekly and a dose is missed, take dose the next morning, and then resume taking 1 dose a week as originally scheduled on chosen day. Do not take 2 doses on the same day to catch up. 4. Do not chew, crush or suck on tablets; take whole. If using oral solution, drink entire contents of bottle and then 1 drink at least /4 cup (2 oz) of water. Do
W = Available in Canada

One 35 mg tablet once weekly or one 5 mg tablet once daily. Treatment of osteoporosis in postmenopausal women. One 70 mg tablet once weekly, 1 bottle of 70 mg oral solution once weekly, or one 10 mg tablet once daily. Osteoporosis in men. One 70 mg tablet once weekly, 1 bottle of 70 mg oral solution once weekly, or one 10 mg tablet once daily. Glucocorticoid-induced osteoporosis. One 5 mg tablet once daily for men and women. For postmenopausal women not receiving estrogen, the recommended dose is one 10 mg tablet daily. Also give clients adequate amounts of calcium and vitamin D. Paget disease of the bone. 40 mg once daily for 6 months for both men and women.

NURSING CONSIDERATIONS
ADMINISTRATION/STORAGE 1. To facilitate stomach delivery and reduce esophagus irritation, do not lie down for at least 30 min following administration. 2. Due to possible interference with absorption, at least 30 min should elapse before taking antacids or calcium supplements. 3. Retreatment for Pagets disease may be considered following a 6-month posttreatment evaluation in clients who have relapsed, based on increases in serum alkaline phosphatase. Retreatment may also be appropriate for those who failed to normalize serum alkaline phosphatase. 4. If dietary intake is insufficient, give supplemental calcium and vitamin D when used for glucocorticoid-induced osteoporosis or Pagets disease. A product called Fosamax Plus D containing alendronate sodium 70 mg and vitamin D3, 2,800 international units, is available to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. 5. No dosage adjustment needed for the elderly.
Bold Italic = life threatening side effect

= black box warning

ALENDRONATE SODIUM
not take aspirin or aspirin-containing products unless approved by provider. 5. If dietary intake is inadequate, take calcium with vitamin D supplements. Regular daily weight bearing exercise encouraged for all. 6. Things that can help prevent/inhibit progression of osteoporosis: take 1,500 mg/day of calcium and 800 International units of vitamin D/day supplements; daily weight-bearing exercise; cessation of cigarette smoking and reduction of excessive alcohol consumption. 7. Stop drug and contact provider if swallowing difficulty, pain behind

breastbone or new/worsening heartburn. 8. Keep all F/U visits to evaluate response to therapy and for adverse SE. OUTCOMES/EVALUATE Prevention of osteoporosis in postmenopausal at risk women Increased bone mass in men Treatment of glucocorticoid-induced osteoporosis in men and women Inhibition of kyphosis and pain R/T bone fracture or deformity Serum alkaline phosphatase levels with Pagets disease

C = see color insert

H = Herbal

IV = Intravenous

E = sound alike drug