Bonemass D

Indications

Alendronic Acid & Vitamin D3 is recommended for:

• Treatment of osteoporosis in postmenopausal women.
• Treatment of osteoporosis in men.
• Enhancing bone mass and reducing fracture risks, including fractures of the spine and hip.

Note: Always follow the advice of a registered healthcare professional when using this medication.

Pharmacology

Alendronate Sodium, a bisphosphonate, acts as a selective inhibitor of osteoclast-mediated bone resorption. To ensure optimal effectiveness, Alendronate should be taken at least 30 minutes before breakfast. Upon administration, it quickly distributes to soft tissues and is rapidly directed to bone or excreted through urine. The plasma protein binding of Alendronate is approximately 78%, and no metabolism has been observed in humans or animals. At the cellular level, Alendronate concentrates at bone resorption sites, particularly beneath osteoclasts, inhibiting their activity. This leads to a positive bone balance where bone formation outpaces resorption, gradually increasing bone mass.

Vitamin D is essential for proper bone health. A deficiency, which can occur due to inadequate sunlight exposure or diet, leads to negative calcium balance, higher parathyroid hormone levels, bone loss, and an increased risk of fractures.

Dosage

For Osteoporosis Treatment in Postmenopausal Women:

• Take one tablet weekly:
  • 70 mg Alendronate + 2800 IU Vitamin D3
  • Or 70 mg Alendronate + 5600 IU Vitamin D3.

The recommended dose for most women is 70 mg Alendronate and 5600 IU Vitamin D3 once weekly.

For Osteoporosis Treatment in Men:

• Take one tablet weekly:
  • 70 mg Alendronate + 2800 IU Vitamin D3
  • Or 70 mg Alendronate + 5600 IU Vitamin D3.

The appropriate dose for most men is 70 mg Alendronate and 5600 IU Vitamin D3 once weekly.

Note: Follow the guidance of a registered healthcare professional when taking this medication.

Administration

For optimal absorption, Alendronic Acid & Vitamin D3 should be taken at least 30 minutes before the first meal, drink, or medication of the day, and only with plain water. Avoid mineral water, food, or other beverages as they can hinder absorption. To minimize the risk of esophageal irritation, swallow the tablet with a full glass of water right after waking. Do not lie down for at least 30 minutes after taking the medication. Do not take it before bedtime.

Note: Always consult a registered healthcare professional before using this medication.

Interactions

Certain medications and supplements can interfere with the absorption of Alendronate. These include calcium supplements, antacids, and other oral medications. Intravenous ranitidine can increase the bioavailability of Alendronate, while NSAIDs and aspirin may exacerbate upper gastrointestinal side effects when used together. Some medications, such as mineral oils, orlistat, bile acid sequestrants (e.g., cholestyramine), anticonvulsants, cimetidine, and thiazides, may impact the absorption or metabolism of Vitamin D.

Contraindications

Alendronic Acid & Vitamin D3 should not be used by individuals with:

• Esophageal abnormalities that delay emptying (e.g., strictures or achalasia).
• Inability to remain upright for at least 30 minutes.
• Hypersensitivity to any component of this medication.
• Hypocalcemia.

Side Effects

Common side effects are usually mild and typically do not require discontinuation of treatment. They may include:

• Esophageal irritation
• Abdominal pain, bloating, or discomfort
• Diarrhea or constipation
• Flatulence
• Musculoskeletal pain
• Headache
• Skin rash or redness
• Temporary decreases in serum calcium and phosphate levels.

Pregnancy & Lactation

This medication is classified under pregnancy category C. While overdoses of Vitamin D have caused teratogenic effects in animal studies, Alendronic Acid & Vitamin D3 should be used during pregnancy only if the benefits outweigh potential risks. Some metabolites of Vitamin D pass into breast milk, but it is unclear whether Alendronate does as well. Caution is advised when prescribing to lactating women.

Precautions & Warnings

Before starting treatment, correct any mineral imbalances, including hypocalcemia. Alendronate can irritate the upper gastrointestinal mucosa, so caution is advised for patients with active upper GI issues, such as dysphagia, esophageal disorders, gastritis, or ulcers. If esophageal issues develop during treatment, patients should discontinue use and consult their doctor.

Use in Special Populations

• Elderly and Renal Insufficiency: No dosage adjustments are needed for elderly patients or those with mild-to-moderate renal insufficiency (creatinine clearance 35-60 mL/min). Alendronic Acid & Vitamin D3 is not recommended for patients with severe renal insufficiency (creatinine clearance <35 mL/min) due to limited experience.

Overdose Effects

Overdose may result in hypocalcemia, hypophosphatemia, and gastrointestinal side effects such as heartburn, esophagitis, gastritis, or ulcers. Symptoms of Vitamin D toxicity include hypercalcemia, nausea, vomiting, anorexia, polyuria, polydipsia, weakness, and lethargy.

Therapeutic Class

Combination therapy for inhibiting bone resorption.

Storage Conditions

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