Ibandronic Acid

Drugs affecting Bone Metabolism · Bisphosphonate

Indications

Reduction of bone damages in metastases in breast cancer. Pathologically elevated serum calcium levels (hypercalcaemia) as a result of tumours. Treatment of post-menopausal osteoporosis to reduce risk of fractures.

Dosage

INJECTION: Reduction of bone damages in metastases in breast cancer: Adults: 6 mg IV every 3-4 wk, added to 500 mL isotonic NaCl soln (or 5% dextrose soln) and infused over 1 hr. Hypercalcaemia: Adults: Patients should be adequately rehydrated with 0.9% NaCl. Single infusion of 2-4 mg, added to same soln. as above and infused over 2 hr based on the severity of hypercalcaemia and tumour type. Treatment of post-menopausal osteoporosis: Adults: IV injection over 15-30 sec, 3 mg every 3 mth. ORAL: Reduction of bone damages in metastases in breast cancer: Adults: 50 mg once daily. Treatment of post-menopausal osteoporosis to reduce risk of fractures: Adults: 150 mg once a mth. Children: Not recommended.

Administration

IV: Administer as a 15-30 seconds bolus. Do not mix with calcium containing solution or other drugs. For osteoporosis, do not administer more frequently than every three months. Infuse over 1 hour for metastatic bone diseases due to breast cancer and over 1-2 hours for hypercalcaemia of malignancy. Stability: Store at controlled room temperature of 25°C; excursions permitted to 15°C-30°C.

Adverse Effects

In patients treated for hypercalcaemia, rise in body temperature, flu-like syndrome, hypocalcaemia. In patients with metastatic bone disease, headache, diarrhoea, myalgia, asthaenia, flu-like illness, abdominal pain, dyspepsia, vomiting.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Hypersensitivity, children. Hypocalcaemia. Precautions: Monitor renal function, serum calcium, phosphate and magnesium during therapy. Severe liver disease; overhydration should be avoided in patients at risk of heart failure. Hypocalcaemia and other disturbances of bone and mineral metabolism. Adequate intake of calcium and vitamin D. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. Risk of osteonecrosis of the external ear canal; advise patients to report ear pain. Risk of rare atypical femoral fracture; advise patients to report thigh, hip or groin pain.

Interactions

Calcium containing soln. Calcium and other multivalent cations (Al, Mg, Fe) containing products including milk and food may interfere with absorption and should be taken 60 min after the dosage. Aminoglycosides, NSAIDs

Advice to Patient

Take oral form atleast 1 hour before the first meal of the day and remain in an upright position for atleast another 1 hour. Take with a full glass of water. Do not eat or drink or take any other medication within 1 hour. Do not chew or crush or suck tablet, swallow whole.

Pharmacokinetics

Metabolism: Not metabolized. Bioavailability: Oral: Minimal; reduced approx. 90% following standard breakfast. Half-life elimination: Oral: 150 mg dose: Terminal: 37 to 157 hours. IV: Terminal: Approx. 5 to 25 hours. Time to peak, plasma: Oral: 0.5 to 2 hours. Excretion: Urine (50% to 60% of absorbed dose, excreted as unchanged drug); feces (unabsorbed drug).

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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