• Treatment and prevention of postmenopausal osteoporosis.
• Treatment of osteoporosis in men.
• Treatment of Paget’s disease of the bone.
• Treatment of corticosteroid-induced osteoporosis in patients (men and women) who are receiving 7.5 mg of prednisone/day (or equivalent) with evidence of decreased bone mineral density.

Contraindicated in:

• Abnormalities of the esophagus that delay esophageal emptying (e.g., strictures, achalasia)
• Inability to stand/sit upright for at least 30 min
• Renal impairment (CCr <35 mL/min)
• OB: Pregnancy.

Use Cautiously in:

• History of upper GI disorders
• Pre-existing hypocalcemia or vitamin D deficiency
• Invasive dental procedures; cancer; receiving chemotherapy, corticosteroids, or angiogenesis inhibitors; poor oral hygiene; periodontal disease; dental disease; anemia; coagulopathy; infection; or poorly fitting dentures (may ↑ risk of jaw osteonecrosis)
• HF or hypertension (effervescent tablet only)
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children.

CV: atrial fibrillation.

Derm: erythema, photosensitivity, rash.

EENT: blurred vision, conjunctivitis, eye pain/inflammation.

GI: abdominal distention, abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, dysphagia, esophageal cancer, esophageal ulcer, esophagitis, flatulence, gastritis, nausea, taste perversion, vomiting.

MS: musculoskeletal pain, femur fractures, osteonecrosis (primarily of jaw).

Neuro: headache.

Resp: asthma exacerbation.

Drug-Drug:

• Calcium supplements, antacids, and levothyroxine may ↓ the absorption of alendronate.
• Doses >10 mg/day ↑ risk of adverse GI events when used with NSAIDs.

Drug-Food:

• Food significantly ↓ absorption. Caffeine (coffee, tea, cola), mineral water, and orange juice also ↓ absorption.

(Generic available)

• Tablets: 5 mg; 10 mg; 35 mg; 40 mg; 70 mg;
• Effervescent tablets (strawberry flavor) (contains 603 mg of sodium/tablet) (Binosto): 70 mg;
• Oral solution (raspberry flavor): 70 mg/75 mL;
• In combination with: cholecalciferol (Fosamax plus D). See Appendix [not included in this PDA edition].

Treatment of Osteoporosis

• PO (Adults): 10 mg once daily or 70 mg once weekly.

Prevention of Osteoporosis

• PO (Adults): 5 mg once daily or 35 mg once weekly.

Paget's Disease

• PO (Adults): 40 mg once daily for 6 mo. Retreatment may be considered for patients who relapse.

Treatment of Corticosteroid-Induced Osteoporosis in Men and Women

• PO (Adults): Men and premenopausal women: 5 mg once daily. Postmenopausal women not receiving estrogen: 10 mg once daily.

Binosto, Fosamax

• Inhibits resorption of bone by inhibiting osteoclast activity.

• Reversal of the progression of osteoporosis with decreased fractures.
• Decreased progression of Paget’s disease.

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification:

Absorption: Poorly absorbed (0.6–0.8%) after oral administration.

Distribution: Transiently distributes to soft tissue, then distributes to bone.

Metabolism/Excretion: Excreted in urine.

Half-life: 10 yr (reflects release of drug from skeleton).

(inhibition of bone resorption)

†After discontinuation of alendronate.

• Instruct patient on the importance of taking exactly as directed, first thing in the morning, 30 min before other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Take alendronate with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a weekly dose is missed, take the morning after remembered and resume the following wk on the chosen day. Do not take 2 tablets on the same day. Do not discontinue without consulting health care professional. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Caution patient to remain upright for 30 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation. Advise patient to discontinue alendronate and notify health care provider if pain or difficulty swallowing, retrosternal pain, or new/worsening heartburn occur.
  • Caution patient not to swallow, chew, or allow undissolved effervescent tablet to dissolve in their mouth; may cause oropharyngeal irritation.
  • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D.
  • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
  • Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to inform health care professional of alendronate therapy prior to dental surgery.
  • Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
  • Advise patient to notify health care professional if blurred vision, eye pain, or inflammation occur.
  • OB: Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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