Drug Interaction:
Caution is advised when bisphosphonates are administered with aminoglycosides ,since both agents may have an additive effect resulting in serum calcium levels for longer period than required
Caution is indicated when used with other potentially nephrotoxic drugs
Attention to be paid to the possibility of hypomagnesiumia developing during treatment In multiple myloma patients riskof renaldysfunction may be increased when intravenous bisphosohonatesare used n combination with thalidomide
Laboratory abnormalities-
Hypophospatemia,blood creatinine and blood urea increased,
hypocalcemia uncommon- Hypomagnasemia rare-hyperkalemia , hypokalemia, hypernatremia
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 178
Name of the Drug- Zoledronic acid 5mg/100ml
solution for infusion
(addl.indcn) Pharmacological Classification- Post-menopausal osteoporosis
Date of Approval- 06-12-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Hypercalcemia of malignancy
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Name of Drug Indication Date of Approval
1.Zoledronic Acid Hypercalcemia 05-11-2001
2.Zoledronic Acid 5mg/100ml 06-12-2007
For Infusion
Addl.indcn
Post-Menopausal Osteoporosis
3.Zoledronic Acid Injection 07-01-2009
5mg/100ml
Addl.Indcn
For the treatment of Osteoporosis in Post-menopausal Women and
in Men who are at increased Risk of Fracture, including Those with a
recent low-trauma HIP fracture
4.Zoledronic Acid For Infusion 01-08-2009
Addl Indin
Prevention of Clinical fracture after HIP Fracture in Men and Women
Adverse Reaction:
Commonly reported adverse reactions are- Fever, arthralgia, myalgia, whichare assocated with an acute phase-reaction.
Uncommon- thrombocytopenia, leukopenia, headache, dizziness, paraethesia, taste disturbances,hypoaesthesia tremor, anxiety, sleep disturbances,
Contra-Indications:
Contraindicated in pregnancy, breast feeding women, in patients with significant hypersensitivity to zoledronic acid, other bisphosphonates or any excepients in the formulation.
High risk groups- Pregnancy and lactation- not enough data on safety andefficacy for use in pregnant women.
Pediatric patients- safety and efficacy not established Renal patients- not recommended.
Hepatic insufficiency- limited data, no specific recommendation.
Cardiac care- overhydration to be avoided Effects on ability to drive or use machines- no data available.
Dosages/ Overdosage Etc:
Indication-
Malignancies involving bones
Zoledronic acid must be used by clinicians exoerienced in the administration of intervenous Bisphophates.
Dosages-
The maximum recommended dose of Zoledronic acid is 4mg as a single intervenous infusion administered over no less than 15 minutes.
In patients with multiple myeloma and metastastic bone lesions from solid tumors, Zoledronic Acid should be infused every 3 or 4 weeks.
Pharmacology/ Pharmacokinetics:
Pharmacology
Zoledronic acid belongs to the class of bisphonates and acts primarily on bone. It is an inhibitor of osteoclastic resorption. The selective action of bisphonates on bone is based on their affinity for mineralised bone,but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Pharmacology- The terminal elimination half life of 167 hrs. describes the low conc of zoledronic acid inplasma upto 28 days. About 44% +/- 18% of dose administered was recovered in the urine within 24 hours.
Pregnancy and lactation:
Pregnancy and lactation.
Not enough data on safety and efficacy for use in pregnant, and breast feeding women.
Pediatric patients-
Safety and efficacy not established
Manufacturer Details