Alendronic Acid & Vitamin D3 is used for:

• Treatment of osteoporosis in postmenopausal women
• Treatment of osteoporosis in men
• Improving bone mass and reducing the risk of fractures, particularly in the hip and spine

Alendronate sodium is a bisphosphonate that inhibits osteoclast-mediated bone resorption. It is most effective when taken at least 30 minutes before breakfast. After administration, it briefly distributes to soft tissues before concentrating in bone or being excreted in urine. Plasma protein binding is approximately 78%, and it is not significantly metabolized in the body. At the cellular level, it accumulates at sites of active bone resorption and suppresses osteoclast activity, resulting in increased bone mass over time. Vitamin D plays a vital role in bone formation by facilitating calcium absorption. Deficiency of Vitamin D—due to inadequate sunlight exposure or poor dietary intake—can lead to negative calcium balance, elevated parathyroid hormone levels, bone loss, and an increased risk of fractures.

Treatment of Osteoporosis in Postmenopausal Women: The recommended dosage is-

• 70 mg alendronate and 2800 IU vitamin D3 or
• 70 mg alendronate and 5600 IU vitamin D3 tablet once weekly.
• For most osteoporotic women, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.

Treatment to Increase Bone Mass in Men with Osteoporosis: The recommended dosage is-

• 70 mg alendronate and 2800 IU vitamin D3 or
• 70 mg alendronate and 5600 IU D3 tablet once weekly.
• For most osteoporotic men, the appropriate dose is 70 mg alendronate and 5600 IU vitamin D3 once weekly.

Administration

To permit adequate absorption, Alendronate & Colecalciferol must be taken at least 30 minutes 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 to reduce the potential for esophageal irritation, Alendronate & Colecalciferol tablet should only be swallowed upon rising for the day with a full glass of water. Patients should not lie down for at least 30 minutes after taking Alendronate until after their first food of the day. Alendronate & Colecalciferol should not be taken at bed time.

Calcium supplements, antacids, and some oral medications may decrease the absorption of Alendronate if taken together. Intravenous ranitidine can increase its bioavailability. The risk of upper gastrointestinal side effects may be higher when used with NSAIDs or aspirin. Mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may reduce Vitamin D absorption. Certain drugs like anticonvulsants, cimetidine, and thiazides may increase Vitamin D metabolism.

• Disorders of the esophagus that delay emptying, such as stricture or achalasia
• Inability to remain upright (standing or sitting) for at least 30 minutes
• Hypersensitivity to any component of the formulation
• Hypocalcemia

Side effects are usually mild and rarely require stopping the medication. These may include esophageal irritation, abdominal pain and bloating, diarrhea or constipation, gas, musculoskeletal pain, headache, rash, redness, and temporary reductions in calcium and phosphate levels.

This medication is classified as pregnancy category C. High doses of Vitamin D have shown harmful effects in animal studies. Therefore, Alendronic Acid & Vitamin D3 should only be used during pregnancy if the expected benefit outweighs the potential risks to both mother and fetus. Vitamin D and its metabolites are known to pass into breast milk, while it is unclear whether alendronate is excreted in human milk. Caution is advised when administering to breastfeeding mothers.

Mineral imbalances, such as hypocalcemia, should be corrected before starting treatment. Alendronate may cause irritation of the upper gastrointestinal lining, so caution is required in patients with conditions like dysphagia, esophageal disorders, gastritis, duodenitis, or ulcers. If symptoms of esophageal irritation occur, patients should discontinue the medication and seek medical advice.

No dose adjustment is needed in elderly patients or those with mild to moderate renal impairment (creatinine clearance 35–60 mL/min). However, this combination is not recommended in patients with severe renal impairment (creatinine clearance below 35 mL/min) due to limited data.

Overdose may lead to hypocalcemia, hypophosphatemia, and gastrointestinal symptoms such as stomach upset, heartburn, esophagitis, gastritis, or ulcer. Excess Vitamin D may cause hypercalcemia, hypercalciuria, loss of appetite, nausea, vomiting, frequent urination, excessive thirst, weakness, and lethargy.

Combination preparation: Bone resorption inhibitor.

Keep in a cool and dry environment, away from light and moisture. Store out of children’s reach.