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 BRAND NAMES
- International: Fosamax Plus, Fosavance, Adrovance
- Italy: Adrovance, Fosavance PI, Vantavo
- U.S.: Fosamax plus D PI
 MECHANISM OF ACTION
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone estrogen fall, since estrogen helps to keep bones healthy.
- Alendronate: Osteoblasts make bone, while osteoclasts resorb or take away bone. Alendronate is a bisphosphonate, it has no direct effect on bone formation, but it stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Alendronate is internalized by osteoclasts, causing disruption of osteoclast cytoskeleton, loss of the ruffled border, and the subsequent loss of ability to resorb bone.
- Colecalciferol (vitamin D3): Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light. In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient. Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed. Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated. The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
- Treatment of postmenopausal osteoporosis
- To increase bone mass in men with osteoporosis
- Postmenopausal Osteoporosis: 70 mg alendronate/2800 international units vitamin D3 or 70 mg alendronate/5600 international units vitamin D3 tablet once weekly.
- To increase bone mass in men with osteoporosis: 70 mg alendronate/2800 international units vitamin D3 or 70 mg alendronate/5600 international units vitamin D3 tablet once weekly.
Swallow tablet with a glass of water, at least 30 minutes before the first food, beverage, or medication of the day. Avoid lying down for 30 minutes. Take supplemental calcium if dietary intake is inadequate.
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.
 DOSAGE FORMS AND STRENGTHS
- Tablets: 70 mg/2800 international units
- Tablets: 70 mg/5600 international units
- Hypersensitivity to to any component
- Inability to stand or sit upright for at least 30 minutes
- Abnormalities of the esophagus which delay emptying such as stricture or achalasia
- Bisphosphonates have been associated with esophagitis, gastritis, esophageal ulcerations and gastroduodenal ulcers. (follow the dosing instructions carefully).
- Hypocalcemia can worsen and must be corrected prior to use
- Bisphosphonates may cause osteonecrosis of of the jaw. Potential predisposing factors are tooth extractions, poor oral hygiene, corticosteroids use, alcohol abuse, chemotherapy and radiotherapy.
- Atypical Femur Fractures have been reported. Patients should be advised to report any thigh or groin pain to rule out an incomplete femur fracture.
- Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop
 PREGNANCY AND LACTATION
- Pregnancy Category C (US). Alendronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
- It is not known whether Alendronate is excreted in human milk, caution should be exercised if administered to nursing women.
 SIDE EFFECTS
Most common adverse reactions are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea and headache. (See precautions for other possible side effects)
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