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Pamidronate information from DrugsUpdate  

See Available Brands of Pamidronate in India

P - Contraindicated in pregnancy
L - Caution when used during lactation
LI - Lab *

Pamidronic acid or pamidronate disodium, pamidronate disodium pentahydrate is a nitrogen containing bisphosphonate, used to prevent osteoporosis. It is marketed by Novartis under the brand name Aredia.

Pharmacodynamics

Pharmacokinetics

Pamidronate is an aminobisphosphonate that inhibits bone resorption by acting on osteoclasts and osteoclast precursors. It also inhibits tumour induced osteolysis and delays or prevents skeletal related events (e.g. fractures, spinal cord depression) and decreases bone pain in patients with lytic metastases.

Onset
24-48 hours.

Duration
Peak effect: max 5-7 days.

Absorption

Poor absorption.

Excretion
Elimination half-life: 21-35 hr. Excretion: Biphasic; urine (approx 50% as unchanged drug) within 120 hours.

Pamidronate Indications / Pamidronate Uses

Information Not Available

Pamidronate Adverse Reactions / Pamidronate Side Effects

Ocurrence and severity of reactions depend on dose and duration of infusion. Anorexia, dyspepsia, nausea, abdominal pain, vomiting; metastases; fatigue; arthralgia, myalgia; anxiety, headache, insomnia, fever; flu-like symptoms; transient bone pain, hypocalcaemia; leucopenia; local reactions at infusion site; somnolence, dizziness, hypotension, rash; hypophosphataemia, hypokalaemia, hypomagnesaemia; osteonecrosis of the jaw (especially in cancer patients); vein irritation and thrombophlebitis; candidiasis; UTI; dyspnoea, cough, upper respiratory tract infections, sinusitis, pleural effusion; atrial fibrillation, hypertension, syncope, tachycardia; psychosis; constipation, GI bleed; uremia; rales, rhinitis.

Potentially Fatal: Acute renal and heart failure.

Precautions

Information Not Available

Special Precautions

May increase the risk of heart failure in patients with cardiac disease. Lactation. Infuse slowly to reduce risk of adverse effects (e.g. infusion site reactions, renal impairment). Do not give as a bolus inj. Risk of neurotoxicity: Each dose should not >90mg (max concentration: 60 mg/250ml). CBC should be performed (patients with preexisting anemia, leukopenia or thrombocytopenia should be closely monitored within the 1st 2 wk of therapy). Bone, myalgia and/or arthralgia (possibly incapacitating) may develop days, mth, or yr after starting bisphosphonate; pain is distinctly different to the acute bone pain, myalgia or arthralgia which may follow administration and normally improves within several days; symptoms normally stop once therapy is discontinued; do not administer to patients with a history of these reactions associated with bisphosphonate therapy. Monitor creatinine before each dose, especially in those predisposed to renal impairment (withhold dose in patients with bone metastases whose renal function declines).

Other Drug Interactions

Additive hypocalcaemic effect with aminoglycosides; decreased absorption with antacids (containing aluminium, calcium or magnesium), administer at a different time of day; decreased absorption with calcium salts; increases risk of GI adverse/toxic effects (especially GI ulcers) with NSAIDs; may increase hypocalcaemic effect of phosphate supplements.

Other Interactions

Information Not Available

Dosage

Intravenous
Paget's disease of bone
Adult: 30 mg daily (over 4 hr) for 3 consecutive days (total dose: 90 mg), may repeat course when clinically indicated. Alternatively, 30 mg wkly for 6 wk (total dose: 180 mg) or 30 mg in the 1st wk, then 60 mg every other wk for 6 wk (total dose: 210 mg); may repeat course 6 mthly until remission of the disease is achieved, or relapse occurs. Max infusion rate: 60 mg/hr. Max total dose: 360 mg/course.
Elderly: Initiate with lower doses.
Renal impairment: Max infusion rate: 20 mg/hr.
CrCl (ml/min)    Dosage Recommendation
<30                       Avoid.

Intravenous

Hypercalcaemia of malignancy
Adult: 15-90 mg (based on initial plasma calcium caoncentration) by slow infusion as a single dose over 2-24 hr or in divided doses over 2-4 days. Generally, plasma-calcium levels should start declining 24-48 hr after a dose with normalisation within 3-7 days. May repeat treatment if normocalcaemia is not achieved within this time or if hypercalcaemia recurs.
Elderly: Initiate with lower doses.
Renal impairment: Max infusion rate: 20 mg/hr.
CrCl (ml/min)    Dosage Recommendation
<30                      Avoid.

Intravenous
Bone metastases
Adult: 90 mg every 3-4 wk. To be given as a 4-hr infusion.
Elderly: Initiate with lower doses.
Renal impairment: If renal function deteriorates: stop treatment until renal function is within 10% of baseline level. If reinstated, infuse over at least 4 hr.
CrCl (ml/min)    Dosage Recommendation
<30                      Avoid, unless case is life threatening tumour induced hypercalcaemia.
30-60    Max rate: 20 mg/hr


Reconstitution
Add 5 ml of sterile water for inj to a 15 mg of vial of lyophilised drug or 10 ml to vials containing 30 or 90 mg of lyophilised drug. Resulting solutions will contain 3 or 9 mg/ml of pamidronate disodium. Allow contents to completely dissolve before withdrawing a dose. Further dilution: 250-1000 ml of 0.45% or 0.9% sodium chloride or 5% glucose.

Incompatibility
Incompatible with calcium containing solutions such as lactated Ringer's.

Food(before/after)

Information Not Available

List of Contraindications

Pamidronate and Pregnancy

P - Contraindicated in pregnancy.


Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Pamidronate and Lactation

L - Caution when used during lactation

Pamidronate and Children

Safety and effectiveness of Pamidronate disodium in pediatric patients have not been established.

Pamidronate and Geriatic

Of the total number of subjects in clinical studies of Pamidronate disodium, approximately 20% were 65 and over, while approximately 15% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Pamidronate and Other Contraindications

History of allergy to biphosphonates. Pregnancy.

Storage

Intravenous: Powder for reconstitution: Store <30°C. Solution for inj: Store <25°C. After reconstitution: Stable for up to 24 hr when refrigerated at 2-8°C.

Lab interference

Intravenous: Powder for reconstitution: Store <30°C. Solution for inj: Store <25°C. After reconstitution: Stable for up to 24 hr when refrigerated at 2-8°C.

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