Fosamax Plus

Fosamax Plus

alendronic acid + colecalciferol




Zuellig Pharma
Concise Prescribing Info
Alendronate Na 70 mg, cholecalciferol 5,600 IU
Osteoporosis in postmenopausal women to increase bone mass, prevent fractures including those of the hip & spine. Osteoporosis in men to prevent fractures.
Dosage/Direction for Use
Should be taken on an empty stomach: Take at least 30 min before the 1st food/beverage/medication w/ a full glass of water upon arising for the day. Swallow whole, do not chew/suck. Do not lie down for at least 30 min & until after 1st food. Do not take at bedtime.
Hypersensitivity. Esophagus abnormalities (eg, stricture or achalasia), hypocalcemia, inability to stand or sit upright for at least 30 min.
Special Precautions
Discontinue use if dysphagia, odynophagia, retrosternal pain, new or worsening heartburn develops. Local irritation of upper GI mucosa; active upper GI problems eg, dysphagia, esophageal diseases, gastritis, duodenitis or ulcers. Osteonecrosis of the jaw (ONJ) & external auditory canal; bone, joint &/or muscle pain; low-energy subtrochanteric & proximal femoral shaft fractures. Evaluate stress fractures, known causes & risk factors eg, vit D deficiency, malabsorption, glucocorticoid use, previous stress fracture, low extremity arthritis or fracture, extreme or increased exercise, DM, chronic alcohol abuse. Poor oral hygiene, co-morbid disorders (eg, periodontal &/or other pre-existing dental disease, anemia, coagulopathy, infection), smoking. Hypoparathyroidism, Ca malabsorption. Invasive dental surgery eg, tooth extraction, dental implants. Correct hypocalcemia & other disorders affecting mineral absorption prior to therapy. Monitor serum Ca, phosphate & urine. Concomitant use w/ chemo- & RT, corticosteroids, angiogenesis inhibitors, bisphosphonates. Not recommended in severe renal insufficiency (CrCl <35 mL/min). Not to be used during pregnancy & lactation. Not to be given to childn.
Adverse Reactions
Hypersensitivity, urticaria, myalgia, malaise, asthenia; nausea, vomiting, esophagitis, esophageal erosions & ulcers; bone, joint &/or muscle pain; dizziness, vertigo, dysgeusia; rash, pruritus, alopecia.
Drug Interactions
Interfered absorption by Ca supplements, antacids. Greater increased bone mass w/ hormone replacement therapy. GI irritation w/ NSAIDs. Impaired absorption w/ olestra, mineral oils, orlistat, bile acid sequestrants eg, cholestyramine, colestipol. Increased metabolism w/ anticonvulsants, cimetidine, thiazides.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BB03 - alendronic acid and colecalciferol ; Belongs to the class bisphosphonates, combinations. Used in the treatment of bone diseases.
Fosamax Plus 70 mg/5600 IU tab
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