Overview
DESCRIPTION Pamidronate disodium is a bisphosphonate available in 30 mg, 60 mg, or 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains: 3 mg Pamidronate Disodium; 47 mg Mannitol, USP; Water for Injection, USP, q.s.
Mechanism of Action
CLINICAL PHARMACOLOGY The principal pharmacologic action of pamidronate disodium is inhibition of bone resorption. Although the mechanism of antiresorptive action is not completely understood, several factors are thought to contribute to this action. Pamidronate disodium adsorbs to calcium phosphate (hydroxyapatite) crystals in bone and may directly block dissolution of this mineral component of bone. In vitro studies also suggest that inhibition of osteoclast activity contributes to inhibition of bone resorption. In animal studies, at doses recommended for the treatment of hypercalcemia, pamidronate disodium inhibits bone resorption apparently without inhibiting bone formation and mineralization.
Indications
- INDICATIONS AND USAGE Hypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment.
Common Doses
- 13.5 mg
- 90 mg
- 30 mg
- 3.0 mg
Dosage
DOSAGE AND ADMINISTRATION Hypercalcemia of Malignancy Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful. Moderate Hypercalcemia The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.
Contraindications
- CONTRAINDICATIONS Pamidronate disodium is contraindicated in patients with clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.
Side Effects
- ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Studies Hypercalcemia of Malignancy Transient mild elevation of temperature by at least 1°C was noted 24 to 48 hours after administration of pamidronate disodium in 34% of patients in clinical trials.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.