Indications:
This kit is designed for the effective treatment and prevention of osteoporosis. It works to enhance Bone Mineral Density (BMD) and significantly reduce the risk of vertebral fractures.
Use only as prescribed by a registered healthcare provider.
Pharmacology:
Ibandronic Acid (Ibandronate Sodium Monohydrate) belongs to a class of nitrogen-containing bisphosphonates, which work by inhibiting osteoclast-mediated bone resorption. It targets bone tissue due to its strong affinity for hydroxyapatite, a key component of the bone matrix. By reducing osteoclast activity, Ibandronate decreases bone resorption and turnover, leading to a net increase in bone mass. In postmenopausal women, this action helps counteract excessive bone turnover, thus promoting bone health.
The combination of Coral Calcium and Colecalciferol (Vitamin D) ensures superior absorption. Coral Calcium contains Calcium Carbonate, along with trace minerals such as Magnesium. Its chemical structure is closer to that of natural bone, enhancing bioavailability compared to other sources of Calcium Carbonate. Vitamin D3 plays a crucial role in helping the body absorb Calcium from the digestive tract and maintaining proper calcium balance.
Dosage & Administration:
- Ibandronic Acid: Take one 150 mg tablet of Ibandronic Acid once a month, on the same date each month.
- To maximize the effects, it is recommended to also take two 500 mg Calcium tablets and 200 IU of Vitamin D3 daily, either in divided doses or as directed by your healthcare provider.
Instructions for Use:
- Day 1: Take the Ibandronic Acid tablet on an empty stomach, at least 60 minutes before eating or taking any other medication, including Calcium, antacids, or vitamins. Swallow the tablet whole with a glass of plain water, while standing or sitting upright. Do not lie down for at least 60 minutes after taking the tablet. Avoid chewing or sucking the tablet.
- Day 2–31: Take one tablet of Calcium and Vitamin D3 after meals in the morning and evening, as directed.
Pediatric Use: The safety and efficacy of this kit in children have not been established.
Consult your healthcare provider before use.
Interactions:
- Ibandronic Acid: Certain products containing calcium or multivalent cations (e.g., aluminum, magnesium, iron) and foods such as milk or antacids may interfere with the absorption of Ibandronate. It may also interact with H2 blockers like Ranitidine.
- Calcium (Coral) and Vitamin D: Oral Calcium can interfere with the absorption of tetracycline and fluoride. Allow at least 3 hours between taking these medications. Thiazide diuretics can decrease renal excretion of Calcium. Phenytoin, barbiturates, and glucocorticoids can alter Vitamin D metabolism. Foods like spinach, cereals, and dairy products may reduce Calcium absorption.
Contraindications:
- Ibandronic Acid: Not suitable for individuals with esophageal conditions that delay esophageal emptying (e.g., stricture or achalasia), those unable to sit or stand upright for 60 minutes, or those with hypocalcemia or hypersensitivity to Ibandronic Acid.
- Calcium & Vitamin D: Contraindicated in cases of hypersensitivity to any of the components, hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiency, and during Digoxin therapy (requires close monitoring of serum calcium).
Side Effects:
- Ibandronic Acid: Common side effects include hypertension, dyspepsia, nausea, abdominal pain, muscle cramps, back pain, and respiratory issues. Less common effects may include skin rash, headache, dizziness, and insomnia.
- Calcium & Vitamin D: The most frequent side effects are gastrointestinal discomfort, including flatulence, diarrhea, and constipation. Rarely, prolonged use may result in hypercalciuria or hypercalcemia.
Pregnancy & Lactation:
- Pregnancy: Classified as Category C. There are no well-controlled studies on its use during pregnancy. This kit should only be used if the benefits outweigh the risks to the mother and fetus.
- Nursing Mothers: The excretion of this kit in breast milk is unknown. Caution is advised when administering this kit to nursing mothers.
Precautions & Warnings:
- Ibandronic Acid: Caution is necessary for individuals with active gastrointestinal conditions (e.g., Barrett’s esophagus, ulcers). Treat any pre-existing hypocalcemia or bone/mineral disorders before starting therapy. Severe musculoskeletal pain and osteonecrosis of the jaw (mainly in cancer patients undergoing dental procedures) have been reported with bisphosphonates.
- Calcium & Vitamin D: Monitor serum calcium levels in patients with mild to moderate renal impairment. Increase fluid intake for patients with a history of renal stones.
Overdose:
Overdose may lead to hypocalcemia, hypophosphatemia, and gastrointestinal issues. Seek immediate medical attention if an overdose is suspected.
Therapeutic Class:
Bisphosphonate preparations
Storage Conditions:
Store at temperatures not exceeding 30°C. Keep away from light and out of reach of children.
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