Uses of Alen D:
- Osteoporosis
Treatment of osteoporosis in postmenopausal women: One tablet once weekly.
Treatment to increase bonemass in men with osteoporosis: One tablet once weekly.
Hepatic Impairment No dosage adjustment needed.
Combined preparations: Inhibiting bone resorption
Alendronate Sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Alendronate is effective when administered at least 30 minutes before breakfast. It transiently distributes to soft tissues following administration but is then rapidly distributed to bone or excreted in the urine. Protein binding in human plasma is approximately 78%. There is no evidence that Alendronate is metabolised in animals or humans. At the cellular level, Alendronate shows preferential localization to sites of bone resorption, specially under osteoclasts. It inhibits osteoclast activity. In addition, bone formation exceeds bone resorption, leading to progressive gains in bone mass. Vitamin D is required for normal bone formation. Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture.
How to use
Alendronic Acid + Vitamin D3:
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it.
Alendronic Acid + Vitamin D3 is to be taken empty stomach.
Administration:
Concomitant iron, calcium supplements and antacids hinder alendronate absorption. Concomitant aspirin or NSAIDs may increase the incidence of adverse GI effects.
Adult Dose:
Upper GI disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct vitamin D and calcium deficiency before starting therapy. To be taken half an hr before breakfast and remain upright for at least 30 minutes after admin. Not recommended for use in patients with CrCl <35 ml/min.
Renal Dose:
Alendronic acid reduces bone resorption by inhibiting the action of osteoclasts.
Hypocalcaemia; oesophageal abnormalities and factors which delay oesophageal emptying; severe renal impairment; hypersensitivity; inability to stand or sit upright for <30 min. Pregnancy, lactation.
Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia.
Inability to stand or sit upright for at least 30 minutes.
Hypersensitivity to any component of this product.
Hypocalcaemia.
Common
- Headache
- Musculoskeletal (bone, muscle or joint) pain
- Back pain
- Indigestion
- Diarrhea
- Heartburn
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).
CrCl (ml/min)
<35 Not recommended.
Pregnancy category C. Overdoses of vitamin D have shown teratogenic effects in pregnant animals. Alendronic Acid & Vitamin D3 (Colecalciferol) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Cholecalciferol and some of its active metabolites pass into breast milk. It is not known whether alendronate is excreted in human milk. Caution should be exercised when administered to lactating women.
Precaution:
Osteopetrosis, postmenopausal osteoporosis, Paget's disease of bone
Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy.
Store in a cool and dry place. Protect from light & moisture. Keep out of the reach of children.
Combined preparations: Inhibiting bone resorption
Alendronate Sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast mediated bone resorption. Alendronate is effective when administered at least 30 minutes before breakfast. It transiently distributes to soft tissues following administration but is then rapidly distributed to bone or excreted in the urine. Protein binding in human plasma is approximately 78%. There is no evidence that Alendronate is metabolised in animals or humans. At the cellular level, Alendronate shows preferential localization to sites of bone resorption, specially under osteoclasts. It inhibits osteoclast activity. In addition, bone formation exceeds bone resorption, leading to progressive gains in bone mass. Vitamin D is required for normal bone formation. Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture.
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.
