Unimed Pamidronate

Unimed Pamidronate

pamidronic acid

Manufacturer:

Mylan Lab

Distributor:

Unimed
Concise Prescribing Info
Contents
Pamidronate disodium
Indications/Uses
Conditions associated w/ increased osteoclast activity eg, predominantly lytic bone metastases & multiple myeloma. Tumour-induced hypercalcaemia. Paget's bone disease.
Dosage/Direction for Use
Slow IV infusion Adult & elderly Predominantly lytic bone metastases & multiple myeloma 90 mg as single infusion every 4 wk. Patient w/ bone metastases who receive chemotherapy at 3-wkly intervals 90 mg on 3-wkly schedule. Infusion rate: Not to exceed 60 mg/hr. Conc: Not to exceed 90 mg/250 mL. Multiple myeloma Not to exceed 90 mg in 500 mL over 4 hr. Tumour-induced hypercalcaemia Recommended total dose: 15-90 mg in single or multiple infusion over 2-4 consecutive days. Max: 90 mg for both initial & repeated courses. Conc: Not to exceed 90 mg in 500 mL over 4 hr. Paget's bone disease 30-mg 6-unit doses once wkly or 3-unit doses every other wk. Total dose: 180-210 mg. Mild to moderate renal impairment Infusion rate: Not to exceed 90 mg over 4 hr.
Contraindications
Hypersensitivity to pamidronate disodium or other biphosphonates.
Special Precautions
Not to be given as bolus inj. Osteonecrosis of the jaw; bone, joint &/or muscle pain; patients who have undergone thyroid surgery; cardiac disease; convulsions. Adequate Ca & vit D supplementation in patients w/ Paget's bone disease. Monitor standard hypercalcaemia-related metabolic parameters eg, serum Ca, phosphate & creatinine during therapy. Perform dental exam w/ appropriate preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Ensure adequate hydration prior to administration especially patients on diuretics. Not to be given w/ other biphosphonates. May affect ability to drive or operate machinery. Not to be given in severe renal impairment (CrCl <30 mL/min); on haemodialysis. Hepatic impairment. Not to be used during pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Fever, influenza-like symptoms; hypocalcaemia, hypophosphataemia. Anaemia, thrombocytopenia, lymphocytopenia; symptomatic hypocalcaemia, headache, insomnia, somnolence; conjunctivitis; HTN; nausea, vomiting, anorexia, abdominal pain, diarrhoea, constipation, gastritis; rash; transient bone pain, arthralgia, myalgia, generalized pain; infusion site reactions; hypokalemia, hypomagnesaemia, increased serum creatinine.
Drug Interactions
Synergistic effect w/ calcitonin. Increased risk of renal dysfunction w/ thalidomide. Not to be used concomitantly w/ other biphosphonates. Concomitant use w/ nephrotoxic drugs.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA03 - pamidronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Unimed Pamidronate soln for inj 3 mg/mL
Packing/Price
10 mL x 1's
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