Apo-Alendronate

Apo-Alendronate

alendronic acid

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Alendronate Na
Dosage/Direction for Use
Treatment of osteoporosis in postmenopausal women & in men 70 mg once wkly or 10 mg once daily. Prevention of osteoporosis in postmenopausal women 5 mg once daily. Treatment & prevention of glucocorticoid-induced osteoporosis in men & women 5 mg once daily; Postmenopausal women not receiving estrogen 10 mg once daily. Paget's disease of bone in men & women 40 mg once daily for 6 mth.
Administration
Should be taken on an empty stomach: Take w/ a full glass (200-250 mL) of plain water at least ½ hr before the 1st food/drink/medication of the day & remain in sitting/upright position for at least ½ hr. Do not take at bedtime or before arising for the day. Swallow whole, do not chew/crush. Take supplemental Ca or vit D if dietary intake is inadequate.
Contraindications
Abnormalities of the esophagus which delay esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for at least 30 min. Hypocalcemia. Renal insufficiency (CrCl <35 mL/min). Pregnancy & lactation. Childn <18 yr.
Special Precautions
May cause local irritation of the upper GI mucosa. Discontinue use if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn occur. Active upper GI problems eg dysphagia, esophageal diseases, gastritis, duodenitis or ulcers. Consider causes of osteoporosis other than estrogen deficiency, aging & glucocorticoid use. Patients who develop osteonecrosis of the jaw should receive appropriate antibiotic therapy &/or oral surgery. Avoid invasive dental procedures in patients w/ cancer & those on chemotherapy, head & neck radiotherapy, corticosteroids or w/ poor oral hygiene. Monitor for atypical, low-energy or low trauma fractures of the femoral shaff. Correct hypocalcemia & other disorders affecting mineral metabolism (eg, vit D deficiency) prior to therapy.
Adverse Reactions
Abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distention, gastritis; musculoskeletal pain; headache; taste perversion.
Drug Interactions
Ca supplements & antacids; ranitidine IV; hormone replacement therapy (oestrogen ± progestin). ASA-containing products (concomitant use w/ >10 mg alendronate dose); NSAIDs.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Apo-Alendronate tab 70 mg
Packing/Price
4's
Form
Apo-Alendronate tab 10 mg
Packing/Price
3 × 10's
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