RiteMED Alendronic Acid

Osteoporosis in postmenopausal women. Prevention of postmenopausal osteoporosis. Increases bone mass in men w/ osteoporosis. Glucocorticoid-induced osteoporosis in men & women receiving glucocorticoids in a daily dose equiv to ≥7.5 mg of prednisone & who have low bone mineral density. Paget's disease of bone in men & women.

Treatment of osteoporosis Postmenopausal women & men One 70 mg tab once wkly or one 10 mg tab once daily. Prevention of osteoporosis Postmenopausal women One 5 mg tab once daily. Treatment & prevention of glucocorticoid-induced osteoporosis Men & women 5 mg once daily. Postmenopausal women not receiving estrogen 10 mg once daily. Treatment of Paget's disease of bone 40 mg daily for 6 mth, may be repeated after an interval of a further 6 mth.

Should be taken on an empty stomach: Take w/ a full glass of plain water only, at least 30 min before the 1st food/drink/medication of the day & remain in sitting/upright position for at least 30 min. Swallow whole, do not chew/crush.

Hypersensitivity.

Patients w/ active upper GI problems eg, known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers. Discontinue use if patient develops dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Duration of exposure to bisphosphonates may increase risk of osteonecrosis of the jaw. Consider discontinuing use in patients requiring invasive dental procedures. Correct hypocalcemia prior to initiating therapy, & monitor serum Ca & symptoms of hypocalcemia during therapy in patients w/ other disorders affecting mineral metabolism eg, vit D deficiency. Ensure adequate Ca & vit D intake in patients w/ Paget's disease of bone & in patients receiving glucocorticoids. Suspect patient w/ history of bisphosphonate exposure who presents w/ thigh or groin pain of having an atypical fracture & evaluate to rule out an incomplete femur fracture. Assess for symptoms & signs of fracture in the contralateral limb in patients presenting w/ an atypical fracture. Ascertain the gonadal hormonal status of both men & women & consider appropriate replacement prior to treatment. Measure bone mineral density at initiation of therapy & repeat after 6-12 mth of combined alendronic acid & glucocorticoid treatment. Not recommended in patients w/ CrCl <35 mL/min. Pregnancy & lactation. Not for use in childn.

Headache, dizziness, vertigo, dysgeusia; abdominal pain, constipation, diarrhea, flatulence, indigestion, vomiting, duodenal, gastric & esophageal ulcer, esophageal erosions, perforation & stricture, esophagitis, acute ulcerative pharyngitis; hypersensitivity reaction; arthralgia, aseptic necrosis of bone of jaw, bone pain, myalgia, joint swelling, low-energy femoral shaft fracture; rash (occasionally w/ photosensitivity), pruritus, alopecia, rarely severe skin reactions including SJS & TEN; rarely uveitis, scleritis or episcleritis; fever, flu-like symptoms, disturbances in serum electrolytes (most commonly hypocalcemia & hypophosphataemia).

Interfered absorption w/ Ca, antacids, or oral medications containing multivalent cations.

Agents Affecting Bone Metabolism

M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Rx