Unimed Pamidronate

Unimed Pamidronate Dosage/Direction for Use

pamidronic acid

Manufacturer:

Mylan Lab

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
Pamidronate Disodium must never be given as a bolus injection. Pamidronate Disodium must be infused slowly. The infusion rate should not exceed 60 mg/hr (1 mg/min), and the concentration of Pamidronate Disodium in the infusion solution should not exceed 90 mg/250 mL. A dose of 90 mg should normally be administered as a 2 hr infusion solution. However, in patients with multiple myeloma and in patients with tumour induced hypercalcaemia, it is recommended not to exceed 90 mg in 500 mL over 4 hrs. In order to minimize local reactions at the infusion site, the cannula should be inserted carefully into a relatively large vein.
Adults and Elderly: Predominantly Lytic Bone Metastases and Multiple Myeloma: The recommended dose is 90 mg administered as a single infusion every 4 weeks.
In patients with bone metastases who receive chemotherapy at 3-weekly intervals, Pamidronate Disodium 90 mg may also be given on a 3-weekly schedule.
Tumour-Induced Hypercalcaemia: Patients must be adequately rehydrated prior to and during administration of Pamidronate Disodium. The total dose of Pamidronate Disodium to be used for a treatment course depends on the patient's initial serum calcium levels. The following guidelines are derived from clinical data on uncorrected calcium values. However, doses within the ranges given are also applicable for calcium values corrected for serum protein or albumin in rehydrated patients. (See table.)

Click on icon to see table/diagram/image

The total dose of Pamidronate Disodium may be administered either in a single infusion or in multiple infusions over 2-4 consecutive days. The maximum dose per treatment course is 90 mg for both initial and repeated courses.
A significant decrease in serum calcium is generally observed 24-48 hrs after administration of Pamidronate Disodium, and normalization is usually achieved within 3-7 days. If normocalcaemia is not achieved within this time, a further dose may be given. The duration of the response may vary from patient-to-patient and treatment can be repeated whenever hypercalcaemia recurs. Clinical experience to date suggests that Pamidronate Disodium may become less effective as the number of treatments increases.
Paget's Disease of Bone: The recommended total dose of Pamidronate Disodium for a treatment course is 180-210 mg. This can be administered either in 6-unit doses of 30 mg once a week (total dose 180 mg), or in 3-unit doses of 60 mg every week. If unit doses of 60 mg are used, it is recommended to start the treatment with an initial dose of 30 mg (total 210 mg).
This regimen, omitting the initial dose, can be repeated after 6 months until remission of disease is achieved, and when relapse occurs.
Renal impairment: Pamidronate Disodium should not be administered to patients with severe renal impairment (creatinine clearance < 30 mL/min) unless in cases of life-threatening tumour-induced hypercalcaemia where the benefit outweighs the potential risk.
As with other IV bisphosphonates, renal monitoring is recommended ie., measurement of serum creatinine prior to each dose of Pamidronate Disodium. In patients receiving Pamidronate Disodium for bone metastases who show evidence of deterioration in renal function, Pamidronate Disodium treatment should be withheld until renal function returns to within 10 % of the baseline value. This recommendation is based on a clinical study, in which renal deterioration was defined as follows: For patients with normal baseline creatinine, increase of 0.5 mg/dL and normal or impaired renal function indicates that the dose adjustment is not necessary in mild (creatinine clearance 61-90 mL/min) to moderate renal impairment (creatinine clearance 30-60 mL/min). In such patients, the infusion rate should not exceed 90 mg/4 hr (approximately 20-22 mg/hr).
Hepatic impairment: A pharmacokinetic study indicates that no dose adjustment is necessary in patients with mild to moderate abnormal hepatic function.
Children: There is no clinical experience with Pamidronate Disodium in children.
Mode of Administration: Intravenous administration.
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