Bonemass D Tablet

Osteoporosis in postmenopausal women, Osteoporosis in men to increase bone mass

Treatment of osteoporosis in postmenopausal women: One tablet once weekly. Treatment to increase bone mass in men with osteoporosis: One tablet once weekly.

Dosing in renal insufficiency: No dosage adjustment is necessary for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). CrCl (ml/min) <35 Not recommended.

No dosage adjustment is necessary for the elderly. No overall differences in efficacy or safety were observed between these patients and younger patients, but the greater sensitivity of some older individuals cannot be ruled out. Dietary requirements of vitamin D 3 are increased in the elderly.

Hepatic Impairment No dosage adjustment is needed. Alendronate Sodium As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary Cholecalciferol Vitamin D 3 may not be adequately absorbed in patients who have malabsorption due to inadequate bile production.

Tablets should be swallowed whole with plenty of water while sitting or standing; to be taken on an empty stomach at least 30 minutes before breakfast (or another oral medicine); the patient should stand or sit upright for at least 30 minutes after taking the tablet.

Abnormalities of the esophagus which delay emptying such as stricture or achalasia Inability to stand/sit upright for at least 30 minutes Hypocalcemia Hypersensitivity to any component of this product

Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. Hypocalcemia can worsen and must be corrected prior to use. Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. Osteonecrosis of the Jaw has been reported. Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture. Monitoring Parameters Monitor renal function and serum calcium, phosphate and magnesium.

Not Classi Alendronic Acid Pregnancy Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized. Lactation Not known whether drug present in human breast mild, affects milk production or has effects on infants Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition Vitamin D3 Pregnancy There are no adequate and well-controlled studies in pregnant women Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Animal studies Calcifediol has been shown to be teratogenic in rabbits when given in doses 8-16 times the human dose of 60 mcg/day, based on body surface area Lactation Limited data suggest calcifediol is poorly excreted in human milk; caution if administered to a breastfeeding female

Calcium supplements/antacids or oral medications containing multivalent cations interfere with the absorption of alendronate. Use caution when co-prescribing aspirin/nonsteroidal antiinflammatory drugs that may worsen gastrointestinal irritation. Some drugs may impair the absorption or increase the catabolism of cholecalciferol (vitamin D 3). Additional vitamin D supplementation should be considered.

The most common side-effect is digestive reactions. 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 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.

Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption; decreases mineral release and collagen or matrix breakdown in bone. The principal action of 1,25-dihydroxyvitamin D 3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation, and bone resorption.

Bonemass D 70 mg+2800 IU Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Alendronic Acid + Vitamin D3.