alendronic acid + colecalciferol




Metro Pharma
Concise Prescribing Info
Alendronic acid (as alendronate Na trihydrate) 70 mg, colecalciferol (vit D3) 5,600 IU
Postmenopausal osteoporosis in women who are not receiving vit D supplementation & at risk of vit D insufficiency. Reduces risk of vertebral & hip fractures.
Dosage/Direction for Use
Hypersensitivity. Esophagus abnormalities & other factors which delay esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcaemia.
Special Precautions
Alendronate: Patients w/ active upper GI problems eg, dysphagia, esophageal disease, gastritis, duodenitis, ulcers, or w/ recent history (w/in previous yr) of major GI disease eg, peptic ulcer or active GI bleeding or surgery of the upper GIT other than pyloroplasty; Barett's esophagus. Esophageal irritation eg, dysphagia, pain or swallowing or retrosternal pain or new or worsening, heartburn. Discontinue use if esophageal reactions eg, esophagitis, esophageal ulcers & erosions occur. Osteonecrosis of the jaw in patients w/ cancer receiving bisphosphonates IV, chemotherapy & corticosteroids. Perform dental exam prior to treatment. Bone, joint &/or muscle pain. Atypical fractures of the femur in patients receiving long-term treatment of osteoporosis. Correct hypocalcemia, bone & mineral metabolism disorders prior therapy. Renal impairment. Colecalciferol: Leukemia, lymphoma, sarcoidosis. Patients w/ vit D3 malabsorption. May affect the ability to drive & use machines. Pregnancy & lactation. Childn >18 yr.
Adverse Reactions
Musculoskeletal pain. Headache, dizziness; vertigo; abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer, dysphagia, abdominal distension, acid regulation; alopecia, pruritus; joint swelling; asthenia, peripheral edema.
Drug Interactions
Alendronate: Food, beverage (including mineral water), Ca supplements, antacid & some oral medicines may interfere alendronate absorption. May cause GI irritation w/ NSAIDs. Colecalciferol: May impair absorption w/ olestra, mineral oils & bile acid sequestrants (eg, cholestyramine, colestipol). May increase catabolism 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.
Resovon Tab 70 mg/5600 IU
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