Handbook of clinical drug data.pdf - Me and My Life

754 RENAL AND ELECTROLYTESParameters to Monitor. Monitor serum calcium, phosphorus, and creatinine. Inosteoporosis, monitor bone mineral density by dual x-ray absorptiometry and forradiologic evidence of fractures. For evidence of active Paget’s disease, monitorurinary hydroxyproline and creatinine. Assess pain in patients with Paget’s diseasewho present with pain. (See Bisphosphonates Comparison Chart.)PAMIDRONATE DISODIUMArediaPharmacology. Pamidronate is a nitrogen-containing bisphosphonate that isabout 100 times as potent as etidronate in inhibiting bone resorption in the rat. 97(See Alendronate.)Administration and Adult Dosage. IV for hypercalcemia of malignancy (moderatehypercalcemia: corrected serum calcium of 12–13.5 mg/dL) 60–90 mg. 113The 60 mg dose is given as an initial, single-dose infusion over at least 4 hr, andthe 90 mg dose must be given by an initial, single-dose infusion over 24 hr; (severehypercalcemia: corrected serum calcium >13.5 mg/dL) 90 mg as an initial,single-dose infusion over 24 hr.Corrected Serum Calcium = Serum Calcium in mg/dL + (0.8 × [4 – Serum Albumin in g/dL]).IV for Paget’s disease 30 mg/day as a 4-hr infusion on 3 consecutive days for atotal of 90 mg. IV for osteolytic bone lesions of multiple myeloma 90 mg oncemonthly as a 4-hr infusion. 114 IV for osteolytic bone metastases of breast cancer90 mg q 3–4 weeks as a 2-hr infusion. 115,116Special Populations. Pediatric Dosage. Safety and efficacy not established.Geriatric Dosage. Same as adult dosage.Other Conditions. Although pharmacokinetic data are lacking, dosage adjustmentappears unnecessary in patients with hepatic impairment. Renal clearance is correlatedwith Cl cr and renally impaired patients excrete less unchanged drug. 117 In patientsreceiving intermittent therapy, dosage adjustment is probably unnecessary.Dosage Forms. Inj 30, 90 mg.Pharmacokinetics. Fate. Oral bioavailability is estimated to be 0.3%. 109Pamidronate is not metabolized and eliminated exclusively by renal excretion.About 46 ± 16% of the drug is excreted unchanged in the urine within 120 hr.t ¹⁄₂. 2.5 hr.Adverse Reactions. Generalized malaise has occurred. Hypocalcemia has beenreported in patients with hypercalcemia and Paget’s disease. Abdominal pain,anorexia, constipation, nausea, and vomiting have been reported in at least 15%of patients receiving pamidronate for hypercalcemia and 5% of patients withPaget’s disease. Transient mild temperature elevation (1°C) has occurred. Redness,swelling/induration, and pain on palpation can occur at the IV insertionsite.Precautions. Obtain laboratory tests at the start of therapy. (See Parameters toMonitor.) Use with caution in patients with Cl cr >5 mg/dL.