DRATE (Alendronate sodium.)

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PRESENTATION: Tab 10 mg >< 10's. 70 mg >< 4's.
DESCRIPTION: Each tablet contains alendronate sodium equivalent to 10 mg or 70 mg alendronic acid.
ACTIONS: Therapeutic Class: Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone Alendronate sodium is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-mediated bone resorption.
INDICATIONS: Drate 10 and 70 mg: Treatment and prevention of osteoporosis in postmenopausal women. Treatment to increase bone mass in men with osteoporosis. Drate 10 mg: Treatment of glucocorticoid-induced osteoporosis in men and women receiving gluco- corticoids, Treatment of Pagers disease of bone in men and women.
DOSAGE & ADMINISTRATION: 10-mg Tablet; Treatment and Prevention of Osteoporosis in Postmenopausal Women, Treatment to Increase. Bone Mass in Men with Osteoporosis, Treatment of Glucocorticoid -induced Osteoporosis in Men and Women Receiving Glucocorticoids: One 10-mg tab. once daily. Treatment of Pagers Disease of Bone in Men and Women: 40 mg once a day for 6 months. 70-mg Tab: One 70-mg tab once weekly. Drate must be taken at least 1/2 hr before the 1st 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 sodium, To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Drate 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 min and until after their 1st food of the day. Drate should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences. Drate 70 mg: Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate. No dosage adjustment is necessary for the elderly or for patients with mild to moderate renal insufficiency (creatinine clearance 35-60 ml/min). Drate is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.

OVERDOSAGE: No specific information is available on the treatment of over dosage with Drate. Hypocalcemia, hypophosphatemia and upper GI adverse events e.g., upset stomach, heartburn, esophagitis, gastritis or ulcer may result from oral over dosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patients should remain fully upright.
CONTRAINDICATIONS: Abnormalities of the esophagus which delay esophageal emptying e.g., stricture or achalasia, inability to stand or sit upright for at least 30 min, hypersensitivity to any component of Drate, hypocalcemia.
PRECAUTIONS: lf any esophageal reaction occurs; the patients should be instructed to discontinue the drug. Caution should be used when Drate is given to patients with active upper Gl problems e.g., dysphagia, esophageal diseases, gastritis, duodenitis or ulcer.
Use in pregnancy & lactation: Drate has not been studied in pregnant and breastfeeding women and should not be given to them.
Use in children: Drate has not been studied in children.