Zoledronic acid is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of fractures of the hip, vertebrae and extravertebral; clinical prevention of fractures after hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; Treatment of osteoporosis in men and treatment of extra-osteopathy. Treatment should be limited to three doses per year.

Bisphosphonate preparations

Zoledronic acid belongs to the group of nitrogenous bisphosphonates and acts mainly on the bone. It is an inhibitor of mediated bone resorption. The action of bisphosphonates on bone is based on their great affinity for mineralized bone. Intravenous zoledronic acid is quickly distributed to the bones. The main molecular target of zoledronic acid in osteoclasts is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There is no accumulation of the active substance in plasma after multiple doses every 28 days. Zoledronic acid is not metabolized and is excreted unchanged by the kidneys.

Treatment of postmenopausal osteoporosis: The recommended dose is a single 5 mg intravenous infusion of zoledronic acid once a year. If dietary intake is insufficient, it is important for women with osteoporosis to supplement adequate intake of calcium and vitamin D. Prevention of clinical fracture after hip fracture: The recommended dose is 5 mg of zoledronic acid intravenously once Once a year. For patients with a recent low traumatic hip fracture, it is recommended that the first zoledronic acid solution be infused two weeks or more after hip fracture repair. It is also recommended to administer a 50,000 to 125,000 IU loading dose of vitamin D orally or intramuscularly before the first infusion of the zoledronic acid solution. It is recommended that patients receiving treatment supplement calcium and vitamin D intake to prevent clinical fractures after hip fractures. Treatment of male osteoporosis: The recommended dose is a single 5 mg intravenous infusion of zoledronic acid once a year. If the dietary intake is insufficient, it is important that men with osteoporosis supplement with an adequate amount of calcium and vitamin D. Treatment and prevention of glucocorticoid-induced osteoporosis: The recommended dose is 5 mg of zoledronic acid intravenously one Once a year. If dietary intake is insufficient, it is important to supplement adequate calcium and vitamin D intake for patients with osteoporosis. Treatment of Paget's disease of bone: The recommended dose is a single 5 mg intravenous infusion of zoledronic acid. According to relapsed patients with elevated serum alkaline phosphatase, patients whose serum alkaline phosphatase has not normalized, or symptomatic patients, according to the regulations of medical practice 12 months after initial administration, zoledronic acid can be considered Retreatment. For Paget patients with disease, it is recommended to get enough vitamin D while taking zoledronic acid. Furthermore, it is strongly recommended that Paget's disease patients ensure adequate calcium supplementation for at least 10 days after taking zoledronic acid, which is equivalent to at least 500 mg of elemental calcium twice daily.

The drug is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients or to any of the bisphosphonates, hypocalcemia, renal failure (creatinine clearance> 35 mL / min) , current or recent peach uveitis, or history of associated bisphosphonate uveitis, pregnancy and lactation.

The side effects after administration were fever, myalgia, flu-like symptoms, arthralgia and headache, most of which occurred within the first 3 days after the administration of zoledronic acid. Most of these symptoms are mild to moderate in nature and resolve within 3 days of the event. The incidence of these symptoms occurring within the first 3 days after the administration of zoledronic acid can be reduced by administering paracetamol or ibuprofen shortly after the administration of zoledronic acid. Among patients taking zoledronic acid, there are few reports of severe and occasionally disabling pain in the bones, joints, and/or muscles.

Zoledronic acid is contraindicated during pregnancy and breastfeeding women. It is also not recommended for children and adolescents under 18 years of age.

Patients should be adequately hydrated before taking zoledronic acid. This is especially important in the elderly and in patients on diuretic therapy. Adequate hydration can be achieved by drinking two glasses of water (such as water) before and after the infusion. Pre-existing hypocalcaemia should be treated with adequate calcium and vitamin D supplementation prior to initiation of zoledronic acid therapy. Other disorders of mineral metabolism must also be effectively treated (eg, hypoparathyroidism, thyroid surgery, parathyroid surgery, intestinal calcium malabsorption). Physicians should consider clinical monitoring for these patients.

Store below 30 ° C before opening. Avoid moisture and sunlight. Zoledronic acid should be kept out of the reach of children.