📋 Indications & Clinical Dosage
*Treatment of Pagets disease of bone:*
BY IV INF: Adult: 5 mg as a single dose, to be administered over at least 15 minutes, 500 mg elemental calcium twice daily (with vitamin D) for minimum 10 days is recommended following INF.
*Treatment of postmenopausal osteoporosis and osteoporosis in men (including corticosteroid-induced osteoporosis):*
BY IV INF: Adult: 5 mg once yearly as a single dose, to be administered over at least 15 minutes, in patients with a recent low-trauma hip fracture, the dose should be given 2 or more weeks following hip fracture repair; before first INF give 50000-125000 units of vitamin D.
*Reduction of bone damage in advanced malignancies involving bone:*
BY IV INF: Adult: 4 mg every 3-4 weeks, to be administered over at least 15 minutes, calcium 500mg daily and vitamin D 400 units daily should also be taken.
*Hypercalcaemia of malignancy:*
BY IV INF: Adult: 4 mg for 1 dose, to be administered over at least 15 minutes
Children: Not recommended.
💊 Mode of Administration
Infuse solution over at least 15 min to prevent renal toxicity. Reconstitute in SWFI. Once fully dissolved, further dilute in 100 ml NS or D5W prior to administration. Infusion of solution must be completed within 24 hours of initial reconstitution of powder. Solution for injection: Dilute in 100 ml NS or D5W prior to administration, Infusion of solution must be completed within 24 hours.
⛔ Contraindications
Acute gastro-intestinal inflammatory conditions, hypersensitivity to other bisphosphonate.
⚠️ Precautions & Warnings
Atypical femoral fractures, maintain adequate fluid intake during treatment, severe renal and hepatic impairment, cardiac failure. Monitor serum calcium, phosphate, magnesium and renal function. Renal dysfunction reported in patients receiving concomitant NSAIDs.
🔄 Drug Interactions
Aminoglycosides, thalidomide.
⚠️ Adverse Reactions / Side Effects
Bronchospasm, diarrhoea, nausea, hypophosphataemia, hypocalcaemia, creatinine/urea increase, anaemia, headache, conjunctivitis, anorexia, fatigue, skin reactions, vomiting, renal impairment, uveitis. Rare: Atypical femoral fractures, steonecrosis of the external auditory canal, osteonecrosis of the jaw
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated
Lactation / Breastfeeding:
Contraindicated
🧪 Compatibility & Storage Stability
Compatibility: Incompatible with calcium-containing solutions (e.g. LR).
Stability & Storage: Vial: Inj 5 mg: Store at room temperature of 15C-30C. Inj 4 mg: Store concentrated vial and ready to use bottles at 25C; excursions permitted to 15C-30C. Reconstituted solution: For infusion (diluted in 100 ml NS or D5W prior to administration) which is not used immediately after preparation, should be refrigerated at 2C-8C. Ready-to-use bottle: no further preparation is necessary. If reduced dose is necessary for patients with renal impairment withdraw the appropriate volume of solution and replace with an equal amount of NS or D5W. The prepared diluted solution may be refrigerated to at 2C-8C if not used immediately. Infusion of solution must be completed within 24 hours of preparation, must be discarded. Do not reuse.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.