Indications
Bonemass D is indicated for the treatment of osteoporosis in postmenopausal women and to increase bonemass in men with osteoporosis. Bonemass D alone should not be used to treat vitamin D deficiency.
Dosage & Administration
Treatment of osteoporosis in postmenopausal women: One tablet once weekly.
Treatment to increase bonemass in men with osteoporosis: One tablet once weekly.
Dosing in elderly and renal insufficiency: No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Bonemass D is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Bonemass D must be taken at least one to half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of Alendronate. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Bonemass D should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. Bonemass D should not be taken at bedtime.
Side Effects
The most common side-effect is digestive reactions from Bonemass D. These reactions include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if patients do not drink a full glass of water with Bonemass D or if they lie down in less than 30 minutes or before their first food of the day. Less common side-effects are nausea, vomiting, a full or bloated feeling in the stomach, constipation, diarrhea, black or bloody stools, gas, headache, a changed sense of taste, and bone, muscle, or joint pain.
Precautions
Alendronate Sodium: Hypocalcemia must be corrected before initiating therapy with Bonemass D. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Bonemass D.
Colecalciferol: Bonemass D alone should not be used to treat vitamin D deficiency. Patients at increased risk for vitamin D insufficiency (e.g. those who are nursing home bound, chronically ill, over the age of 70 years) should receive vitamin D supplementation in addition to that provided in Bonemass D.
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Contraindications
The drug is contraindicated in abnormalities of the esophagus that delay esophageal emptying such as stricture or achalasia, inability to stand or sit upright for at least 30 minutes, hypocalcemia and hypersensitivity to any component of this product.
Use in Pregnancy & Lactation
There is no studies in pregnant women. Bonemass D should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Colecalciferol and some of its active metabolites pass into breast milk. It is not known whether Alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bonemass D is administered to nursing women. Bonemass D is not indicated for use in children.
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