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Indications & Uses
Zoltero is indicated for:
Pharmacology
Zoledronic Acid is a bisphosphonate, and its action is mainly on bone. It slows down bone resorption by blocking the osteoclasts, the cells that break bone down. Bisphosphonates act selectively on bone because they bind strongly to mineralized bone. After Zoledronic Acid is given intravenously, it moves quickly into bone and settles mostly at sites where bone turnover is high. Inside the osteoclast, its main molecular target is the enzyme farnesyl pyrophosphate synthase. Zoledronic Acid also stays active for a relatively long time, and this is because of how tightly it binds to bone mineral.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Treatment of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion once a year, given intravenously over no less than 15 minutes.
Prevention of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion given intravenously once every 2 years, over no less than 15 minutes.
Osteoporosis in Men: The recommended regimen is a 5 mg infusion once a year, given intravenously over no less than 15 minutes.
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: The recommended regimen is a 5 mg infusion once a year, given intravenously over no less than 15 minutes.
Treatment of Paget's Disease of Bone: The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes, and it should run at a constant rate.
Re-treatment of Paget's Disease: Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase. It may also be considered in those who failed to bring their serum alkaline phosphatase back to normal, or in those with symptoms, as medical practice dictates.
Calcium and Vitamin D Supplementation: Instruct patients being treated for Paget's disease of bone on why calcium and vitamin D supplementation matters for keeping serum calcium levels steady, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units of vitamin D daily, particularly in the 2 weeks after Zoledronic Acid is given.
Instruct patients being treated for osteoporosis to take supplemental calcium and vitamin D if their diet doesn't supply enough. An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.
Side Effects
Zoledronic Acid can cause fever, muscle pain, headache, joint pain and pain in the arms or legs, and these were the most common side effects, each seen in more than 10% of people. Other important side effects were flu-like illness, nausea, vomiting, diarrhea and eye inflammation.
Cautions & Contraindications
Warnings & Precautions
Hypocalcemia may get worse during treatment with Zoledronic Acid [For osteoporosis], so patients must be given enough calcium and vitamin D. Renal impairment needs particular care. A single dose should not be more than 5 mg, and the infusion should run for no less than 15 minutes. Kidney toxicity may be greater in patients who already have renal impairment or other risk factors, including advanced age or dehydration. Creatinine clearance should be checked before each dose. Osteonecrosis of the Jaw (ONJ) has been reported. Before treatment starts, the prescriber should do a routine oral exam on every patient. Atypical femur fractures have also been reported. Anyone with thigh or groin pain should be evaluated to rule out a femoral fracture. Severe bone, joint and muscle pain may occur. If severe symptoms appear, hold back future doses of Zoledronic Acid.
Contraindications
Zoledronic Acid must not be used in people with hypocalcemia, in patients with creatinine clearance less than 35 mL/min or evidence of acute renal impairment, or in those with hypersensitivity to any component of Zoledronic Acid.
Pregnancy & Breastfeeding
Zoledronic Acid can harm an unborn baby. Women who could become pregnant should be told about this risk. It should not be given to women who are breastfeeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Zoledronic Acid [For osteoporosis] is not indicated for children.
Geriatric use: Take special care to monitor kidney function in older patients.
Renal impairment: Zoledronic Acid [For osteoporosis] is contraindicated in patients with a creatinine clearance of less than 35 mL/min and in those with evidence of acute renal impairment. So no dose adjustment is needed in patients with a creatinine clearance of 35 mL/min or more.
Hepatic impairment: The liver does not metabolise Zoledronic Acid [For osteoporosis]. No clinical data are available on its use in patients with hepatic impairment.
Overdose
Anyone who has been given more than the recommended dose of Zoledronic Acid [For osteoporosis] should be watched closely. An overdose can cause significant kidney impairment, and low levels of calcium (hypocalcemia), phosphorus (hypophosphatemia) and magnesium (hypomagnesemia). If the serum levels of calcium, phosphorus or magnesium fall to a clinically relevant degree, they should be corrected with intravenous calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively. A single dose of Zoledronic Acid [For osteoporosis] should not go above 5 mg, and the intravenous infusion should run for no less than 15 minutes.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Zoledronic Acid below 30° C until you open it, and protect it from moisture and light. Always keep it out of the reach and sight of children.
Common questions about Zoltero 5 mg/100 ml
What is Zoltero 5 mg/100 ml IV Infusion?
Zoltero 5 mg/100 ml IV Infusion is a medicine that contains Zoledronic Acid [For osteoporosis]. It is made by Beximco Pharmaceuticals Ltd. It belongs to the Bisphosphonate preparations group of medicines.
What is Zoltero used for?
Zoltero is used for: Osteoporosis.
What are the side effects of Zoltero?
Zoledronic Acid can cause fever, muscle pain, headache, joint pain and pain in the arms or legs, and these were the most common side effects, each seen in more than 10% of people. Other important side effects were flu-like illness, nausea, vomiting, diarrhea and eye inflammation.
Can I take Zoltero during pregnancy or while breastfeeding?
Zoledronic Acid can harm an unborn baby. Women who could become pregnant should be told about this risk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Zoltero?
Anyone who has been given more than the recommended dose of Zoledronic Acid [For osteoporosis] should be watched closely. An overdose can cause significant kidney impairment, and low levels of calcium (hypocalcemia), phosphorus (hypophosphatemia) and magnesium (hypomagnesemia). In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Zoltero?
Keep Zoledronic Acid below 30° C until you open it, and protect it from moisture and light. Always keep it out of the reach and sight of children.
Do I need a prescription for Zoltero?
Zoltero is a prescription (Rx) medicine. Take it as your doctor advises.