Apo-Alendronate/Vitamin D3

Apo-Alendronate/Vitamin D3

alendronic acid + colecalciferol

Manufacturer:

Apotex

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Alendronate 70 mg, cholecalciferol 140 mcg
Indications/Uses
Osteoporosis in post-menopausal women & in men.
Administration
Should be taken on an empty stomach: Take at least 30 min before the 1st food, drink or medication of the day, w/ a full glass of plain water only & remain in sitting/upright position for at least 30 min. Do not take at bedtime or before arising for the day. Swallow whole, do not chew/crush. Failure to follow these instructions may increase the risk of esophageal adverse experiences. Take Ca & vit D supplements if dietary intake is inadequate.
Contraindications
Hypersensitivity. Esophagus disorders; hypocalcemia; severe kidney disease. Patients unable to stand or sit upright for at least 30 min.
Special Precautions
Patients w/ cancer, gum disease, poor oral hygiene, or DM; patients undergoing chemotherapy or radiotherapy; smoker; heavy alcohol drinker; patients w/ medical problems including known kidney disease; dental problems; allergies; swallowing or digestive problems. Concomitant use w/ corticosteroids, or immunosuppressive drugs; angiogenesis inhibitors (eg, bevacizumab). Reports of osteonecrosis of the external auditory canal, mainly w/ long-term therapy. Possible risk of atypical thigh bone fractures. Risk of digestive problems, especially if patients do not drink the recommended amount of water w/ Apo-Alendronate/Vitamin D3 &/or if they lie down in <30 min or take tab in <30 min before the 1st food of the day. May affect ability to drive or operate machinery. Do not take during pregnancy or lactation. Not indicated for childn <18 yr.
Adverse Reactions
Digestive problems eg, nausea, vomiting, diarrhea or constipation; esophageal reactions; bone, muscle &/or joint pain; joint swelling or swelling of hands or legs; transient flu-like symptoms; rash that may be made worse by sunlight, hair loss; allergic reactions eg, hives or, rarely, swelling of the face, lips, tongue &/or throat; dizziness, vertigo or a changed sense of taste; symptoms of low blood Ca; mouth ulcers when the tab was chewed or dissolved in the mouth.
Drug Interactions
Altered absorption w/ Ca supplements, antacids, & some oral medicines; artificial fat substitutes, mineral oils, orlistat & other cholesterol-lowering medicines, cholestyramine, colestipol. Decreased effectiveness of vit D w/ medicines for seizures, 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.
Presentation/Packing
Form
Apo-Alendronate/Vitamin D3 70 mg/140 mcg tab
Packing/Price
4's
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