Finished product reference

Ibandronic Acid

Tablet · Oral · 150 mg

List code
7475
Pharmacologic class
Bisphosphonate (nitrogen-containing)

What it is and how it works

Ibandronic acid binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption by inhibiting farnesyl pyrophosphate synthase. This reduces bone turnover and increases bone mineral density.

Indications

Treatment of postmenopausal osteoporosis in women at increased risk of fracture; prevention of skeletal events in breast cancer with bone metastases; tumour-induced hypercalcaemia (intravenous).

Dosage and administration (summary)

Osteoporosis: 150 mg orally once monthly, or 3 mg by intravenous injection over 15–30 seconds every 3 months. Oncology indications: 50 mg orally daily or 6 mg intravenous infusion every 3–4 weeks, according to the product information.

Contraindications

Hypocalcaemia; hypersensitivity. Oral tablets: oesophageal abnormalities delaying emptying (stricture, achalasia) and inability to stand or sit upright for at least 60 minutes.

Warnings and precautions

Correct hypocalcaemia and vitamin D deficiency before treatment. Osteonecrosis of the jaw, atypical femoral fractures and osteonecrosis of the external auditory canal have been reported; dental assessment is advised. Oral tablets must be taken fasting with plain water, remaining upright for 60 minutes; not recommended in severe renal impairment (creatinine clearance below 30 mL/min).

Pregnancy

Should not be used in pregnancy.

Storage and supply

Store below 25–30 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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