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Alendronate (alendronate sodium)

OTHER BRAND NAMES

Fosamax

THERAPEUTIC CLASS

Bisphosphonate

DEA CLASS

RX

INDICATIONS

Treatment of osteoporosis in postmenopausal women. Treatment to increase bone mass in men w/ osteoporosis. (Tab) Prevention of osteoporosis in postmenopausal women. Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone and who have low bone mineral density (BMD). Treatment of Paget's disease of bone in men and women.

ADULT DOSAGE

Osteoporosis

In Postmenopausal Women:
Treatment:
70mg tab/sol once weekly or 10mg tab qd
Prevention:
35mg tab once weekly or 5mg tab qd

Treatment to Increase Bone Mass in Men w/ Osteoporosis:
70mg tab/sol once weekly or 10mg tab qd

Treatment of Glucocorticoid-Induced Osteoporosis:
In men and women receiving glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone and who have low bone mineral density

5mg tab qd; 10mg tab qd for postmenopausal women not on estrogen

Paget's Disease

Treatment of Paget's Disease of Bone in Men and Women:
40mg tab qd for 6 months

Retreatment: Following a 6-month post-treatment evaluation period, may consider retreatment if relapse occurs (based on increases in serum alkaline phosphatase). May also consider retreatment if treatment fails to normalize serum alkaline phosphatase

Missed Dose

If once-weekly dose is missed, administer 1 dose on am after patient remembers; do not administer 2 doses on same day but return to 1 dose once a week, as originally scheduled on chosen day

DOSING CONSIDERATIONS

Renal Impairment
CrCl <35mL/min: Not recommended

ADMINISTRATION

Oral route

Take upon arising for the day
Swallow tabs w/ full glass of water (6-8 oz); do not chew or suck on the tab
Oral sol should be followed by at least 2 oz of water
Take at least 1/2 hr before the 1st food, beverage, or medication of the day w/ plain water only
Do not lie down for at least 30 min and until after 1st food of the day

HOW SUPPLIED

Sol: 70mg [75mL]; Tab: 5mg, 10mg, 35mg, 40mg; (Fosamax) 70mg

CONTRAINDICATIONS

Esophageal abnormalities that delay esophageal emptying (eg, stricture, achalasia), inability to stand or sit upright for at least 30 min, hypocalcemia. (Sol) Patients at increased risk of aspiration.

WARNINGS/PRECAUTIONS

May cause local irritation of the upper GI mucosa; caution w/ active upper GI problems (eg, Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers). Esophageal reactions (eg, esophagitis, esophageal ulcers/erosions) reported; d/c and seek medical attention if dysphagia, odynophagia, retrosternal pain, or new/worsening heartburn develops. Use therapy under appropriate supervision in patients who cannot comply w/ dosing instructions due to mental disability. Gastric and duodenal ulcers reported. Treat hypocalcemia and other disorders affecting mineral metabolism (eg, vitamin D deficiency) prior to therapy. Asymptomatic decreases in serum Ca2+ and phosphate may occur; ensure adequate Ca2+ and vitamin D intake especially in patients w/ Paget's disease of bone and in patients taking glucocorticoids. Severe and occasionally incapacitating bone, joint, and/or muscle pain reported; d/c if severe symptoms develop. Osteonecrosis of the jaw (ONJ) reported; risk may increase w/ duration of exposure to drug. If invasive dental procedures are required, discontinuation of treatment may reduce risk for ONJ. Consider discontinuation if ONJ develops. Atypical, low-energy, or low-trauma fractures of the femoral shaft reported; evaluate any patient w/ a history of bisphosphonate exposure who presents w/ thigh/groin pain to rule out incomplete femur fracture, and consider interruption of therapy. (Tab) Consider discontinuation after 3-5 yrs of use in patients at low risk for fracture; periodically reevaluate risk for fracture in patients who d/c therapy. Ascertain gonadal hormonal status and consider appropriate replacement before initiating therapy for glucocorticoid-induced osteoporosis.

ADVERSE REACTIONS

Nausea, abdominal pain, musculoskeletal pain, acid regurgitation, flatulence, dyspepsia, constipation, diarrhea.

DRUG INTERACTIONS

Ca2+ supplements, antacids, or oral medications containing multivalent cations will interfere w/ absorption; wait at least 1/2 hr after taking alendronate before taking any other oral medications. Increased incidence of upper GI adverse events in patients receiving concomitant therapy w/ daily doses of alendronate >10mg and aspirin-containing products. NSAID use is associated w/ GI irritation; use w/ caution.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Bisphosphonate; binds to hydroxyapatite found in bone, and specifically inhibits osteoclast-mediated bone resorption.

PHARMACOKINETICS

Absorption: Absolute bioavailability (0.64% in women), (0.59% in men). Distribution: Vd= at least 28L; plasma protein binding (78%). Elimination: (IV) Urine (50%); T1/2 >10 yrs.

ASSESSMENT

Assess for esophageal abnormalities, ability to stand or sit upright for at least 30 min, hypocalcemia, risk for ONJ, active upper GI problems, mental disability, renal impairment, drug hypersensitivity, any other conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions. (Tab) For glucocorticoid-induced osteoporosis treatment, assess gonadal hormonal status and obtain BMD.

MONITORING

Monitor for signs/symptoms of ONJ, atypical fractures, esophageal reactions, musculoskeletal pain, hypocalcemia, and other adverse reactions. Monitor serum Ca2+ levels. Periodically reevaluate the need for continued therapy. (Tab) Monitor BMD after 6-12 months of combined alendronate and glucocorticoid treatment. For Paget's disease treatment, monitor serum alkaline phosphatase periodically.

PATIENT COUNSELING

Inform about benefits/risks of therapy. Instruct to follow all dosing instructions and inform that failure to follow them may increase risk of esophageal problems. Instruct to take upon arising for the day and at least 1/2 hr before the 1st food, beverage, or medication of the day w/ plain water only; advise to swallow tab w/ 6-8 oz of water and to follow oral sol by at least 2 oz of water. Advise to avoid lying down for at least 30 min after taking the drug and until after 1st food of the day. Instruct to take supplemental Ca2+ and vitamin D if daily dietary intake is inadequate. Counsel to consider weight-bearing exercise along w/ the modification of certain behavioral factors (eg, cigarette smoking, excessive alcohol use), if these factors exist. Advise to d/c and consult physician if symptoms of esophageal disease develop. Instruct that if a once-weekly dose is missed, to take 1 dose the am after patient remembers and to return to taking the dose as originally scheduled on patient's chosen day; instruct not to take 2 doses on the same day.

STORAGE

Sol: 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze. Tab: 20-25°C (68-77°F); (Fosamax) 15-30°C (59-86°F).

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