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Zoltero5 mg/100 ml
IV Infusion
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Medicine overview
Indications of Zoltero 5 mg/100 ml
Zoledronic Acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hipvertebral and non-vertebral fracturesprevention of clinical fractures after a hip fracturetreatment and prevention of glucocorticoid-induced osteoporosis
Theropeutic Class
Bisphosphonate preparations
Pharmacology
Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone.
Absorption
It is an inhibitor of osteoclast-mediated bone resorption.
Distribution
Intravenously administered Zoledronic acid is rapidly distributed to bone.
Metabolism
Zoledronic acid is not metabolized and is excreted unchanged via the kidney.
Excretion
Zoledronic acid is not metabolized and is excreted unchanged via the kidney.
Dosage of Zoltero 5 mg/100 ml
Treatment of postmenopausal osteoporosis
Dosage:Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year
Notes:Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate
Prevention of clinical fractures after a hip fracture
Dosage:Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year
Notes:In patients with a recent low-trauma hip fracture, it is recommended to give the first Zoledronic Acid solution for infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of Vitamin-D given orally or via intramuscular route prior to the first administration of Zoledronic Acid solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture
Treatment of osteoporosis in men
Dosage:Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year
Notes:Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate. Treatment and prevention of glucocorticoid-induced osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate
Treatment of paget's disease of bone
Dosage:Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid
Notes:Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose. In patients with paget's disease, adequate Vitamin-D intake is recommended in association with Zoledronic Acid administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget's disease for at least 10 days following Zoledronic Acid administration
| Condition | Dosage | Notes |
|---|---|---|
| Treatment of postmenopausal osteoporosis | Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year | Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate |
| Prevention of clinical fractures after a hip fracture | Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year | In patients with a recent low-trauma hip fracture, it is recommended to give the first Zoledronic Acid solution for infusion two or more weeks after hip fracture repairs. It is also recommended to have a loading dose of 50,000 to 125,000 IU of Vitamin-D given orally or via intramuscular route prior to the first administration of Zoledronic Acid solution for infusion. Supplemental Calcium and Vitamin-D intake is recommended for patients treated to prevent clinical fractures after a hip fracture |
| Treatment of osteoporosis in men | Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year | Adequate supplemental Calcium and Vitamin-D intake is important in men with osteoporosis if dietary intake is inadequate. Treatment and prevention of glucocorticoid-induced osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in patients with osteoporosis if dietary intake is inadequate |
| Treatment of paget's disease of bone | Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid | Re-treatment with Zoledronic Acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose. In patients with paget's disease, adequate Vitamin-D intake is recommended in association with Zoledronic Acid administration. In addition, it is strongly advised that adequate supplemental Calcium corresponding to at least 500 mg elemental Calcium twice daily is ensured in patients with paget's disease for at least 10 days following Zoledronic Acid administration |
Administration of Zoltero 5 mg/100 ml
The dose of 5 mg Zoledronic acid must be administered over at least 15 minutes. Zoledronic Acid should be administered intravenously via a infusion line, given at a constant infusion rate. The infusion time must not be less than 15 minutes.
Interaction of Zoltero 5 mg/100 ml
Specific drug-drug interaction studies have not been conducted with Zoledronic acid. Zoledronic acid is eliminated by renal excretion. Caution is indicated when Zoledronic Acid is administered in conjunction with drugs that can significantly impact renal function (e.g. aminoglycosides or diuretics that may cause dehydration).
Contraindications
The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.
Side Effects of Zoltero 5 mg/100 ml
The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoledronic Acid administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoledronic Acid, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoledronic Acid administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoledronic Acid.
Pregnancy & Lactation
Zoledronic Acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.
Precautions & Warnings
Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Pre-existing hypocalcaemia must be treated by adequate intake of Calcium and Vitamin-D before initiating therapy with Zoledronic Acid. Other disturbances of mineral metabolism must also be effectively treated (e.g. diminished parathyroid reserve, thyroid surgery, parathyroid surgery, intestinal Calcium malabsorption). Physicians should consider clinical monitoring for these patients.
Overdose Effects of Zoltero 5 mg/100 ml
Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral Calcium and/or an infusion of Calcium.
Storage Conditions
Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.
Use In Special Populations
Patients with renal impairment: The use of Zoledronic Acid in patients with creatinine clearance <35 mL/min is not recommended due to limited clinical safety data in such patients. No dose adjustment is necessary in patients with creatinine clearance >35 mL/min.Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.Elderly patients: No dose adjustment is required. However, because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.Zoledronic Acid must not be mixed or given intravenously with any other medication and must be given through a separate infusion line at a constant infusion rate. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during the preparation of the infusion. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.After opening, the solution is chemically and physically stable for at least 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. Zoledronic Acid solution for infusion must not be allowed to come into contact with any Calcium or other divalent cation-containing solutions.
Frequently Asked Questions
What is Zoltero 5 mg/100 ml used for?
Zoledronic Acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures; prevention of clinical fractures after a hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; treatment of osteoporosis in men and for the treatment of paget's disease of bone. Treatment should be restricted to three…
What is the dosage of Zoltero 5 mg/100 ml?
Treatment of postmenopausal osteoporosis: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid administered once a year. Adequate supplemental Calcium and Vitamin-D intake is important in women with osteoporosis if dietary intake is inadequate. Prevention of clinical fractures after a hip fracture: Recommended dose is a single intravenous infusion of 5 mg Zoledronic Acid admin…
What are the side effects of Zoltero 5 mg/100 ml?
The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoledronic Acid administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoledronic Acid…
Who should not take Zoltero 5 mg/100 ml?
The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 mL/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation.
What precautions should be taken with Zoltero 5 mg/100 ml?
Patients must be appropriately hydrated prior to administration of Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy. Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. Pre-existing hypocalcaemia must be treated by adequate intake of Calcium and Vitamin-D before initia…
Is Zoltero 5 mg/100 ml safe during pregnancy and breastfeeding?
Zoledronic Acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.