Bone Guard 150

Indications

Bone-Guard is recommended for:

• Osteoporosis Treatment: Specifically for postmenopausal women.
• Osteoporosis Prevention: Particularly in postmenopausal women.
• Osteoporosis Management: For men at risk.

Osteoporosis Diagnosis: Confirmation can be made through a T-score of less than -2.0 SD and a history of osteoporotic fractures, or a T-score below -2.5 SD without previous fractures.

Consult a registered healthcare professional before using this medication.

Pharmacology

Ibandronic Acid functions primarily by inhibiting bone resorption. In clinical studies, it effectively prevents bone degradation linked to hormonal changes, tumors, and other factors. Research in young rats shows that it enhances bone mass by suppressing natural bone resorption without hindering mineralization, even at high dosages.

This potent bisphosphonate selectively targets osteoclasts—cells responsible for bone breakdown—without impacting their recruitment. Due to its strong affinity for hydroxyapatite, Ibandronic Acid effectively reduces bone turnover, helping restore bone mass in postmenopausal women.

Dosing Flexibility: Both daily and intermittent dosing regimens yield decreased bone resorption, reflected by lower serum and urinary markers of bone turnover, increased bone mineral density (BMD), and a reduced fracture risk.

Dosage & Administration

For effective treatment, the recommended dosage of Ibandronic Acid is 150 mg in the form of a film-coated tablet, taken once a month on the same date.

Administration Guidelines:

• Take the tablet 60 minutes before the first meal or any other medications, aside from water.
• Swallow the tablet whole with a full glass of plain water (180-240 ml) while sitting or standing upright. Avoid lying down for 60 minutes post-ingestion.
• Only plain water should accompany the tablet; avoid mineral waters high in calcium.
• Do not chew or dissolve the tablet to prevent oral irritation.

If a monthly dose is missed, take it the next morning unless it’s within 7 days of the next scheduled dose. In that case, continue with the regular monthly schedule without doubling doses.

Consult a registered healthcare professional before using this medication.

Interaction

Calcium supplements, antacids, and medications containing multivalent cations (like aluminum, magnesium, or iron) can interfere with Bone-Guard absorption. Patients should wait 60 minutes post-Bone-Guard intake before consuming these substances.

Clinical studies indicate no significant interactions with tamoxifen, hormone replacement therapy, or melphalan/prednisolone in multiple myeloma patients. Although IV ranitidine can increase Bone-Guard bioavailability, no dosage adjustments are necessary.

Bone-Guard does not affect major hepatic P450 isoenzymes and has low plasma protein binding, minimizing the risk of displacing other drugs. It is primarily eliminated via renal excretion.

Contraindications

Ibandronic Acid is contraindicated for individuals with:

• Known hypersensitivity to ibandronic acid or its excipients.
• Uncorrected hypocalcemia.
• Esophageal abnormalities affecting emptying, such as strictures or achalasia.
• Inability to sit upright for at least 60 minutes.

Side Effects

Common side effects include dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, and dizziness.

Pregnancy & Lactation

Pregnancy: Ibandronic Acid should not be used during pregnancy, as animal studies indicate potential reproductive risks.

Nursing Mothers: Use is contraindicated while breastfeeding due to minimal concentrations found in breast milk.

Precautions & Warnings

Before initiating Bone-Guard therapy, treat any existing hypocalcemia or mineral metabolism disorders. Patients should ensure adequate calcium and vitamin D intake.

Due to potential local gastrointestinal irritation, caution is advised for patients with active upper GI conditions. Severe gastrointestinal issues, including esophagitis or ulcers, may arise, especially with non-compliance to dosing instructions.

Osteonecrosis of the jaw (ONJ) has been reported in patients taking bisphosphonates. Risk factors include cancer diagnosis and dental procedures. Patients should inform their healthcare provider of any dental work planned during treatment.

Use in Special Populations

Renal Impairment: No dosage adjustments for mild to moderate impairment (creatinine clearance ≥30 ml/min). Below this threshold, assess the risk-benefit ratio.

Hepatic Impairment: No dosage adjustments necessary.

Elderly: No adjustments needed.

Children: Safety and efficacy in individuals under 18 have not been established.

Overdose Effects

While specific overdose treatments for Bone-Guard are not established, oral overdosage may cause gastrointestinal distress. Milk or antacids may help bind the medication, and patients should remain upright without inducing vomiting.

Therapeutic Class

Bisphosphonate Preparations

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.