MEDAC DISODIUM PAMIDRONATE
PAMIDRONATE DISODIUM · by AMGOMED PHARMA
Composition
Inj 3 mg: Per ml, Pamidronate disodium 3 mg; 5 ml (15 mg) vial; 10 ml (30 mg) vial. Inj 6 mg: Per ml: Pamidronate disodium 6 mg: 10 ml (60 mg) vial. Inj 15 mg: Per ml: Pamidronate disodium 15
Indications & Dosage
Hypercalcaemia of malignancy: BY IV INF: Adult: 15-60 mg, to be given via cannula in a relatively large vein as a single INF or in divided doses over 2-4 days, dose adjusted according to serum calcium concentration; max. 90 mg per course. Osteolytic lesions and bone pain in bone metastases associated with breast cancer or multiple myeloma: BY IV INF: Adult: 90 mg every 4 weeks, to be administered via cannula in a relatively large vein, dose may alternatively be administered every 3 weeks, to coincide with chemotherapy in breast cancer. Pagets disease of bone: BY IV INF: Adult: 30 mg every week for a 6 week course (total dose180 mg), alternatively initially 30 mg once weekly for 1 week, then increased to 60 mg every 2 weeks (max. per dose 60 mg) for a 6 week course (total dose 210 mg), to be administered via cannula in a relatively large vein, course may be repeated every 6 months; max. 360 mg per course Adults: Capsule: 200 mg daily. Children: Not recommended.
Administration
Drug must be properly diluted before administration and slowly infused IV (over at least 2 hours). RECONSTITUTION: Powder for injection: Reconstitute by adding 10 ml of sterile water for injection to each vial of lyophilized pamidronate disodium powder, the resulting solution will be 30 mg/ ml or 90 mg/ ml. Pamidronate may be further diluted in 250-1000 ml of 0.45% or 0.9% sodium chloride or 5% dextrose.
Stability
Powder for injection: Store below 30C. The recon-stituted solution made by adding 10 ml of SWFI to each vial of lyophilized powder (3o mg/10 ml or 90 mg/10 ml) will be stable for 24 hours stored under refrigeration at 2C-8T. Solution for injection: Store at 20C-25C.
Precautions
Renal impairment, cardiac disease, previous thyroid surgery, atypical femoral fractures. Ensure adequate hydration, possibility of precipitating convulsions. Monitor serum electrolytes, calcium and phosphate during prolonged use, monitor renal function.
Interactions
Infusions of solutions containing calcium, hy-pocalcaemic therapy, other diphosphonates, plicamycin.
Pregnancy
Positive evidence of risk, use only when no safer alternative exists for a serious problem.
Lactation
: Caution advised
Side Effects
Abdominal pain, anaemia, anorexia, arthralgia, bone pain, constipation, diarrhoea, drowsiness, fever, headache, hypertension, hypomagnesaemia, hypophosphataemia, influenza- like symptoms, insomnia, myalgia, nausea, paraesthesia, rash, symptomatic hypocalcaemia, tetany, thrombocytopenia, vomiting, mild transient pyrexia, transient lymphocytopenia, infusion site reactions, Rarely, leucopenia, anaemia, other biochemical disturbances.