Buy Rezoclastin FS solution 5 mg/6.25 ml

Zoledronic acid

Brand Nativa

In stock 1966 Items

Available since: 2019-09-19

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Clinical Pharmacology

The drug Resoclastin belongs to a new class of highly effective bisphosphonates, which have a selective effect on bone tissue. Zoledronic acid inhibits the activity of osteoclasts, does not have an undesirable effect on the formation, mineralization and mechanical properties of bone tissue. The selective effect of bisphosphonates on bone tissue is based on a high affinity for mineralized bone tissue, but the exact molecular mechanism that inhibits osteoclast activity is still unexplained. In addition to the inhibitory effect on bone resorption, zoledronic acid has direct antitumor properties that provide efficacy in bone metastases.

In vitro, it has been established that zoledronic acid, by suppressing proliferation and inducing apoptosis of cells, has a direct antitumor effect on myeloma cells and breast cancer, and reduces the risk of their metastasis. Inhibition of osteoclastic resorption of bone tissue leads to a decrease in the growth of tumor cells; antiangiogenic and analgesic activity is noted. Zoledronic acid also inhibits the proliferation of human endothelial cells. With hypercalcemia caused by a tumor, decreases the concentration of calcium in the serum.

When using zoledronic acid in patients with postmenopausal osteoporosis (T-test values for bone density of the femoral neck are less than 2.5), a statistically significant reduction in the risk of vertebral fractures and a decrease in the risk of developing one or more vertebral fractures was noted. When treating zoledronic acid in patients with Paget's disease of the bone, a statistically significant, rapid and prolonged therapeutic response, normalization of the level of bone metabolism and alkaline phosphatase plasma concentration was noted.

The drug is also highly effective in patients who have previously received treatment with oral bisphosphonates. It has been established that in the majority of patients with the use of zoledronic acid, the therapeutic response persists throughout the entire period of treatment (about 2 years).

In patients with postmenopausal osteoporosis and Paget's disease of bone, zoledronic acid does not affect the quality of normal bone, does not interfere with the processes of bone remodeling and mineralization, and contributes to the preservation of normal trabecular bone architectonics.

Indications

Hypercalcemia (serum calcium corrected for albumin> 12 mg / dL or 3 mmol / L) induced by malignant tumors.
Metastatic bone lesions in malignant solid tumors and myeloma (to reduce the risk of pathological fractures, compression of the spinal cord, hypercalcemia caused by the tumor, and reduce the need for radiotherapy).
Postmenopausal primary osteoporosis.
Senile form of primary osteoporosis.
Secondary osteoporosis.
Pedzhet's bone disease.

Composition

1 ml of concentrate contains:

active ingredient: zoledronic acid monohydrate 0.85 mg (corresponding to anhydrous zoledronic acid) 0.80 mg;

excipients: D-Mannitol 44.0 mg; sodium citrate dihydrate 5.5 mg (corresponding to anhydrous sodium citrate) 4.8 mg; water for injection up to 1.0 ml.

1 vial contains 6.25 ml (5 mg zoledronic acid) concentrate.

Zoledronic acid is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Rezoclastin FS	Nativa	Russia	solution
Aclasta	Novartis	Switzerland	solution
Resorb	Farm Synthesis	Russia	solution

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Dosage and Administration

Resorb is administered IV, drip for at least 15 minutes. Dosing regimen set individually. The recommended dose is 4 mg every 3-4 weeks.

Adverse reactions

Undesirable reactions are listed below by organs and systems, indicating the frequency of their occurrence. Frequency criteria: very often ≥1 / 10; often ≥1 / 100 -

From the side of blood-forming organs: often - anemia, sometimes - thrombocytopenia, leukopenia; rarely pancytopenia.

On the part of the nervous system: often - headache; sometimes - dizziness, paresthesia, taste disturbances, hypoesthesia, hyperesthesia, tremor, anxiety, sleep disorders; rarely - confusion.

On the part of the organs of vision: often - conjunctivitis; sometimes - blurry vision; very rarely - uveitis, episcleritis.

From the digestive tract: often - nausea, vomiting, anorexia; sometimes - diarrhea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth.

On the part of the respiratory system: sometimes - shortness of breath, cough.

On the part of the skin and skin appendages: sometimes - itching, rash (including erimatosis and macular), increased sweating.

From the musculoskeletal system: often - bone pain, myalgia, arthralgia, generalized pain; sometimes muscle cramps.

Since the cardiovascular system: sometimes - a pronounced increase or decrease in blood pressure; rarely bradycardia.

On the part of the urinary system: often - renal dysfunction; sometimes acute renal failure, hematuria, proteinuria.

For the immune system: sometimes - hypersensitivity reactions; rarely - angioedema.

Contraindications

hypersensitivity to zoledronic acid, other bisphosphonates, or any other components that make up the preparation;
severe renal failure (Cl creatinine -
pregnancy and lactation period;
children and adolescents (safety and efficacy have not been established).

Drug interactions

Calcium-containing solutions, in particular Ringer's solution, cannot be used as solvents.
With simultaneous use with anticancer drugs, diuretics, antibiotics, analgesics, clinically significant interactions are not observed.
Bisphosphonates and aminoglycosides have a unidirectional effect on the concentration of calcium in the blood serum, therefore, if they are given at the same time, the risk of hypocalcemia and hypomagnemia increases.
Caution is necessary with the simultaneous use of zoledronic acid with drugs that potentially have nephrotoxic effects.
In patients with multiple myeloma, there may be an increased risk of developing renal dysfunction after intravenous administration of bisphosphonates in combination with thalidomide.
The drug should not be mixed with other drugs.

Special instructions

Before infusion, ensure adequate patient hydration. If necessary, the introduction of saline is recommended before, in parallel or after the infusion of zoledronic acid. Overhydration of the patient should be avoided due to the risk of cardiovascular complications. Before infusion, ensure that the patient is adequately hydrated. If necessary, the introduction of saline is recommended before, in parallel or after the infusion of zoledronic acid. Overhydration of the patient should be avoided due to the risk of cardiovascular complications.

Overdosage

In case of an accidental overdose of Resorba, the patient should be under constant surveillance.
In the event of hypocalcemia, accompanied by clinical manifestations, it is shown to infuse calcium gluconate.