Pamidronate

 
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Structure

Pamidronate 30
Each vial contains Disodium Pamidronate BP equivalent to Anhydrous Disodium Pamidronate 30 , as sterile, freeze-dried powder for reconstitution with 10 ml of sterile water for injection IP

Pamidronate 60
Each vial contains Disodium Pamidronate BP equivalent to Anhydrous Disodium Pamidronate 60 , as sterile, freeze-dried powder for reconstitution with 10 ml of sterile water for injection IP

Pamidronate 90
Each vial contains Disodium Pamidronate BP equivalent to Anhydrous Disodium Pamidronate 90 , as sterile, freeze-dried powder for reconstitution with 10 ml of sterile water for injection IP

Without a Prescription

Pamidronate is prescribed for:
Hypercalcemia of Malignancy
Pamidronate, in conjunction with adequate hydration, is prescribed for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

Pagetís Disease
Pamidronate is prescribed for the treatment of patients with moderate to severe Pagetís disease of bone.

Osteolytic Bone Metastases of Breast Cancer and Osteolytic lesions of Multiple Myeloma
Pamidronate is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

Dosage and Administration
Reconstitution (for all indications)
Pamidronate is reconstituted by adding 10 mL of Sterile Water for Injection, IP, to each vial, resulting in a solution of 30 /10 mL, 60 mg/10 mL, or 90 mg/10 mL.

Hypercalcaemia of malignancy
Preparation of solution
The daily dose must be administered as an intravenous infusion over at least 4 hours for the 60- dose, and over 24 hours for the 90-mg dose.
The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP.
This infusion solution is stable for up to 24 hours at room temperature.

Dosage

Moderate Hypercalcaemia of Malignancy
The recommended dose of pamidronate in moderate hypercalcemia (corrected serum calcium* of approximately 12-13.5 /dL) is 60 Ė90 mg.
The 60- dose is given as an initial single-dose, intravenous infusion over at least 4 hours. The 90-mg dose must be given by an initial, single-dose, intravenous infusion over 24 hours Severe hypercalcaemia
The recommended dose of pamidronate in severe hypercalcaemia (corrected serum caclium* > 13.5 /dl) is 90 mg. The 90 mg single dose must be given by an initial, single dose intravenous infusion over 24 hours.

Retreatment
Retreatment with pamidronate in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment.
It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.

Pagetís Disease
Preparation of solution
The recommended daily dose of 30 should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.

Dosage
The recommended dose of pamidronate in patients with moderate to severe Pagetís disease of bone is 30 daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.

Retreatment
A limited number of patients with Pagetís disease have received more than one treatment of pamidronate in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.

Osteolytic Bone Lesions of Multiple Myeloma
Preparation of solution
The recommended dose of 90 should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4 hour period on a monthly basis.

Dosage
The recommended dose of pamidronate in patients with osteolytic bone lesions of multiple myeloma is 90 administered as a 4-hour infusion given on a monthly basis.
Limited information is available on the use of pamidronate in multiple myeloma patients with a serum creatinine ? 3.0 /dL.
The optimal duration of therapy is not yet known.
Osteolytic Bone Metastases of Breast Cancer

Preparation of solution
The recommended dose of 90 should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3-4 weeks.

The recommended dose of pamidronate in patients with osteolytic bone metastases is 90 administered over a 2-hour infusion given every 3-4 weeks.

Contraindications

Pamidronate is contraindicated if you have any of the following conditions:
Pamidronate is contraindicated in patients with clinically significant hypersensitivity to pamidronate or other bisphosphonates.

Package

- Vial of 10 ml;
Without Prescription (2017)