Pamisol Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pamidronate disodium

Indications/Uses

Conditions associated w/ increased osteoclast activity eg, predominantly lytic bone metastases from breast cancer & advanced multiple myeloma. Acute management of tumour-induced hypercalcemia. Symptomatic treatment of Paget's bone disease.

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Dosage/Direction for Use

Predominantly lytic bone metastases from breast cancer & advanced multiple myeloma 90 mg as single infusion every 4 wk. Patient w/ bone metastases who receive chemotherapy at 3-wkly intervals 90 mg as single infusion every 3 wk. Infusion rate: Not to exceed 60 mg/hr. Conc: Not to exceed 90 mg/250 mL. Breast cancer patient 90 mg as 2-hr infusion in 250-mL infusion soln. Multiple myeloma Not to exceed 90 mg in 500 mL over 4 hr. Tumour-induced hypercalcaemia Rehydrate w/ NaCl 0.9% before or during treatment. Recommended total dose for each treatment course is titrated according to initial plasma Ca levels. Initial treatment: Total dose for treatment course can be given as single infusion or divided into 2-3 consecutive daily doses. Conc: Not to exceed 90 mg in 500 mL over 4 hr. Paget's bone disease 60 mg as single infusion. Infusion rate: Not to exceed 15-30 mg/2 hr. Conc: Not to exceed 90 mg/L. Mild to moderate renal impairment Max infusion rate: 90 mg over 4 hr. Mild to moderate hepatic impairment Max infusion rate: 20 mg/hr.

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Overdosage

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Contraindications

Hypersensitivity to disodium pamidronate or other bisphosphonates. Pregnancy & lactation.

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Special Precautions

Not to be given as bolus inj. Not to be used in hyperparathyroidism treatment. Hypercalcaemia, patients who have undergone thyroid surgery; multiple myeloma, cardiac disease, precipitated convulsions, jaw osteonecrosis, musculoskeletal pain. Monitor serum electrolytes, Ca & phosphate. Patients w/ Paget's bone disease should be given oral Ca supplements & vit D. Ensure adequate hydration. Not to be used in severe renal impairment. Preexisting renal disease, predisposition to renal impairment, mild to moderate renal impairment. May affect ability to drive & operate machinery. Childn. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Asymptomatic hypocalcaemia, flu-like symptoms, mild fever. Hypocalcaemia, hypophosphataemia. Hypomagnesaemia, hypokalaemia, increased serum creatinine; anaemia, lymphocytopenia, thrombocytopenia; HTN; headache, insomnia, symptomatic hypocalcemia (paraesthesia, tetany), somnolescence; nausea, vomiting, anorexia, abdominal pain, constipation, gastritis; pain, redness, swelling, induration, phlebitis, thrombophlebitis at infusion site; transient bone pain, arthralgia, myalgia, generalised & skeletal pain; rash; conjunctivitis.

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Drug Interactions

Significant hypocalcaemia w/ other bisphosphonates. Synergistic effect w/ calcitonin. Increased risk of renal dysfunction in combination w/ thalidomide. Concomitant use w/ potentially nephrotoxic drugs.

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Storage

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Description

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Action

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MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BA03 - pamidronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Regulatory Classification

Presentation/Packing

Form

Pamisol inj 3 mg/mL

Packing/Price

10 mL x 1's;5 mL x 1's

Form

Pamisol inj 6 mg/mL

Packing/Price

10 mL x 1's

Form

Pamisol inj 9 mg/mL

Packing/Price

10 mL x 1's

Pamisol

pamidronic acid

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH