Zoldriya

Soldria is a solution of monohydrate zoledronic acid combined with additional elements.

Indications Soldria

It is used for hypercalcemia, which develops against a neoplasm that has a malignant character.

It is also prescribed to prevent the development of negative signs in the area of bone tissue in people with malignant tumors or lesions affecting the bones (vertebral compression, fractures of a pathological type, and complications after radiotherapy or surgical procedures).

Release form

The substance is released in the form of a powder for infusion fluid, in flacons with a capacity of 4 mg. In the box - 1 bottle.

Pharmacodynamics

Zoledronic acid is a bisphosphonate, which demonstrates a powerful slowing effect on osteoclastic bone resorption.

The selective effect of bisphosphonates on bone tissue is associated with their strong affinity for mineralized bone tissues. The use of the drug leads to the development of active influence on their structure and improves their mineralization.

In addition to slowing down the processes of resorption, zoledronic acid has a direct antitumor effect on cultured myeloma cells, as well as breast carcinoma. This effect is developed due to a delay in cell proliferation and apoptosis induction processes - the drug has an anti-metastatic effect.

Pharmacokinetics

Information on the pharmacokinetic parameters of drugs with metastases in the bone region was obtained after the administration of 5 and 15-minute infusions (1-time or repeated) with a dosage of 2, 4, and 8 and 16 mg of the substance to 64 patients. It should be taken into account that the pharmacokinetics of drugs from the size of its dosage does not depend.

Since the start of the infusion procedure, the plasma values of the plasma are rapidly increasing. The peak value is noted at the end of the procedure, after which a rapid decrease in the concentration to 10% of Cmax after 4 hours is recorded, and <1% of Cmax after 24 hours with a further prolonged interval of low values not exceeding 0.1% of Cmax to the 2nd infusion produced on the 28th day.

The intravenously injected drug is excreted via the kidneys into 3 phases: first, a rapid 2-stage excretion takes place from the systemic blood flow with a half-life-α of 0.24 hours, and a half-life of β equal to 1.87 hours, and then a prolonged stage with a finite half-life-γ of 146 hours. Cumulation of the drug within the blood plasma with repeated infusions with intervals of 28 days is not documented.

Zolendronic acid does not participate in metabolic processes and is excreted through the kidneys in the unmodified state. During the first 24 hours inside the urine, 39 ± 16% of the portion of the drug is noted. The remainder of the substance is synthesized with bone tissue, after which the back release is performed, followed by renal excretion.

The total clearance level is 5.04 ± 2.5 l / h, regardless of the dosage of Soldria, as well as the age, sex, race and weight of the patient. The extension of the infusion time from 5 to 15 minutes by 30% reduces the level of the active substance at the end of the procedure, but does not affect the plasma values of the AUC.

Dosing and administration

The use of osteoporosis, which develops during postmenopause, male osteoporosis, and also for the therapy and prevention of osteoporosis caused by GCS, and prevention of recurrence of fractures in the femur: 1 infusion of 5 mg of substance produced intravenously.

With Paget's disease appoint a one-time intravenous infusion of a dosage of 5 mg of the drug. The duration of the infusion is at least 15 minutes. People with this disease need to ensure adequate intake of calcium and calciferol in daytime portions for 10 days after the application of Soldria.

Use Soldria during pregnancy

Because the experience of using Zoldria in pregnant women is absent, it should not be used in this period.

Also, there is no evidence of whether the drug is excreted with human milk, which is why it is forbidden to prescribe it and breastfeeding women.

Contraindications

The main contraindications:

• severe intolerance to the active element of the drug and any additional components contained in its composition, or other bisphosphonates;
• severe form of renal failure;
• hypocalcemia.

Side effects Soldria

The use of medication can trigger the following side effects:

• disorders affecting the hematopoietic system: leukemia or thrombocytopenia, as well as anemia. Occasionally there is pancytopenia;
• disorders of the digestive function: vomiting, anorexia, dry mouth mucosa, nausea, constipation, stomatitis, diarrhea or abdominal pain;
• problems with the operation of the central nervous system and PNS: gustatory disorders, anxiety, headaches, tremors, hyperesthesia or hypesisusia, as well as sleep disturbance and dizziness. Occasionally a sense of confusion develops;
• symptoms arising from the ODA: myalgia, pain in the bones and arthralgia. Sometimes there are cramps in the muscles;
• violations of respiratory activity: sometimes there is a cough or dyspnea;
• problems on the part of the CAS: sometimes decreases or increases the level of blood pressure. Occasionally, a bradycardia occurs;
• disorders affecting the urinary function: sometimes there is hematuria, an acute form of kidney failure or proteinuria;
• lesions of the subcutaneous layers and epidermis: rashes (among them macular or erythematous), itching and hyperhidrosis;
• manifestations on the part of the visual organs: weakening of visual acuity or conjunctivitis. Occasionally epicleritis or uveitis develops;
• signs of allergy: symptoms of hypersensitivity. Occasionally Quincke's edema develops;
• local manifestations: irritation, pain and swelling in the area of drug use;
• laboratory test data: an increase in the blood levels of urea with creatinine, the development of hypocalcemia, hypophosphatemia, or hypomagnesemia. Occasionally there is hypernatremia or -kalemia;
• other: the appearance of chills, feelings of malaise or severe fatigue, febrile condition, tides of blood to the skin of the face, and in addition, the development of influenza-like condition, asthenia, pain in the sternum and peripheral edemas, and weight gain.

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Overdose

In case of intoxication causing clinically noticeable hypocalcemia, you can compensate for the condition of the patient with the help of additional intake of calcium or infusion of calcium gluconate.

Interactions with other drugs

It is necessary to combine with great care bisphosphonates with aminoglycosides, because they are capable of leading to the development of additive effects, as a result of which the serum calcium values remain lowered for a longer period than necessary.

Also, you need to carefully combine the drug with diuretic drugs of the loop type, because because of their additive effect, hypocalcemia can develop.

With precautions, Soldria is also combined with other potentially nephrotoxic drugs. It is also necessary to consider the likelihood of hypomagnesemia in the course of therapy.

The appearance of mandibular osteonecrosis was reported with a combination of medication with drugs that have anti-angiogenic activity.

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Storage conditions

Soldria should be kept out of the reach of small children. The temperature is not higher than 25 ° C.

Dissolved in 5 ml of injection water the drug is further diluted with sterile saline solution or 5% glucose - this substance has a shelf life of 24 hours (with a temperature content of 2-8 ° C).

Shelf life

Soldria can be used within 36 hours of the release of the therapeutic drug.

Application for children

Do not use the drug in pediatrics.

Analogues

Analogues of the medication are drugs Aklasta, Zometa, Deztrone with Zolendronic acid-Vista, as well as Metakos and Zolendronic acid-Pharmex.