Zometa
Zometa (Zoledronic Acid)Pharmacological action
Zoledronic Acid , suppressing a proliferation and inducing an apoptosis, has immediate antitumoral an effect concerning cells of a myeloma of the person and a cancer tumour of a mammary gland, and also reduces penetration of cells of a cancer tumour of a mammary gland through an extracellular matrix that testifies to presence at it antimetastatic properties. Besides, Zoledronic acid inhibits a proliferation of cells of an endothelium of the person and in animals causes antiangiogenic action.
At patients with a hypercalcemia caused by a tumour, it has been shown, that action of Zoledronic acids is characterised by depression of concentration of calcium in Serum and reduction of its deducing with urine.
Indications
- The osteolytic, osteoblastic and admixed osteal metastasises of solid tumours and the osteolytic centres at a plural myeloma, as a part of the combined therapy;
- A hypercalcemia caused by a malignant tumour.
Dosage regimen
Zometa enter i.v. driply within 15 minutes.
At osteal metastasises and the osteolytic centres at a plural myeloma as a part of the combined therapy by the adult and to patients of advanced age the recommended dose of a preparation makes 4 mg. Frequency rate of appointment - each 3-4 weeks.
At a hypercalcemia caused by a malignant tumour (concentration of calcium with correction on albumin level> =12.0 mg/dl or 3.0 mmol/l), to adults and patients of advanced age the recommended dose of a preparation makes 4 mg. For maintenance of adequate hydration of the patient normal saline solution introduction before, in parallel or after Zometa infusion is recommended.
Repeated Zometa introduction spend in case of offensive of deterioration after distinct clinical effect (i.e. achievements of value of concentration of calcium in Serum of 2.7 mmol/l and more low). The interval between first and repeated Zometa introduction should be not less than one week as this period of time is necessary for development of full clinical effect. Repeatedly Zometa enter in a dose of 8 mg within 15 minutes.
Usually reached effect of depression of calcium in blood remains within 30 days after introduction of 4 mg Zometa and within 40 days - after introduction of 8 mg.
At application of a preparation for patients with disturbance of function of kidneys it is necessary to mean, that is not required to correction of a regimen of dosage from patients with weakly or moderately expressed disturbances of function of kidneys (level of a serumal creatinine less than 400 mkmol/l or less 4.5 mg/dl. In need of repeated Zometa application it is necessary to define concentration of a serumal creatinine before each infusion.
Rules of preparation and solution use
It is necessary to prepare a solution in aseptic conditions. Each 4 mg Zometa dissolve in 5 ml of water for injections which is applied in ampoules on a vial with a preparation. That the powder was dissolved completely, it is necessary to shake a vial cautiously. If it is necessary to prepare the infusional solution containing 8 mg Zometa , follows above described way to dissolve contents of 2 vials, using 2 ampoules on 5 ml of water for injections. The received solution with a necessary dose (4 mg or 8 mg) plant 100 ml of 0.9 % of a solution of sodium of Sodium chloridum or 5 % of a solution of a glucose. It is impossible to use the solutions containing ions of calcium!
Side effect
The by-effects, registered to a thicket, than individual observations, are listed more low on organs and systems with the indicating of frequency of their occurrence.
Following criteria of an estimation of frequency of occurrence of the undesirable phenomena were used: the concept is "very frequent" (> =10 %); "often" (from> =1 % to <10 %), "sometimes" (from> =0.1 % to <1 %); "seldom" (from> =0.01 % to <0.1 %); extremely seldom (at less than 0.01 %).
From hemopoiesis organs: sometimes - a thrombocytopenia, an anaemia, a leukopenia; seldom - a pancytopenia.
From the central and peripheric nervous system: often - a headache; sometimes - delicacy, paresthesias, disturbance of gustatory sensations, a hypesthesia, a hyperesthesia, a tremor.
From mentality: sometimes - alarm, dream disorders; seldom - the confused consciousness.
From a sight organ: often - a conjunctivitis; sometimes - sight misting.
From the alimentary system: often - a nausea, vomiting, an anorexia; sometimes - a diarrhoeia, a constipation, abdominal pains, a dyspepsia, a stomatitis, dryness in a mouth.
From cardiovascular system: seldom - a bradycardia.
From kidneys: often - disturbance of function of kidneys; sometimes - acute renal insufficiency, a hematuria, a proteinuria.
From immune system: sometimes - hypersensitivity reactions; seldom - a Quincke's disease.
From an organism as a whole: often - fever, a fever, ostealgias and-or muscles; sometimes - an asthenia, peripheric edemas, a pain in a thorax, augmentation of mass of a body.
Local reactions: sometimes - a pain, a boring, a tumescence and infiltrate formation in an injection place.
From laboratory indicators: very often - a hypophosphatemia; often - rising of level of a creatinine and urea in blood serum, a hypocalcemia; sometimes - a hypomagnesiemia; seldom - a hyperpotassemia, a hypopotassemia, a hypernatremia.
Contraindications
- Pregnancy;
- A lactemia (thoracal feeding);
Special indicatings
At all patients whom Zometa is prescribed repeatedly, before each introduction it is necessary to define concentration of a creatinine in blood serum. If the obtained data testify to deterioration of function of kidneys, it is necessary to estimate a condition of the patient and to draw a conclusion on, whether the potential advantage of preparation introduction over possible risk prevails.
Considering possibility of rising of concentration of a creatinine in blood serum at Zometa application, and also absence of data on application for patients with serious disturbances of function of kidneys (concentration of a creatinine in blood serum> =400 mkmol/l or> =4.5 mg/dl), preparation appointment is not recommended to this contingent of patients, unless the expected advantage prevails over potential risk.
Before infusion it is necessary to exclude presence of a dehydration at the patient. For maintenance of adequate hydration of the patient normal saline solution introduction before, in parallel or after Zometa infusion is recommended. It is necessary to avoid an overhydratation of the patient because of risk of occurrence of complications from cardiovascular system.
After Zometa introduction the constant control over concentration of calcium, phosphorus, magnesium and a creatinine in blood serum is necessary.
If the hypocalcemia, a hypophosphatemia or a hypomagnesiemia develops, the short-term maintenance therapy is necessary.
Previous renal insufficiency and long application of a preparation concern risk factors of occurrence of similar complications in high doses (8 mg), reduction of time of infusion.
Use in pediatrics
Overdosage
Cases of acute Zometa overdosage it was not observed. The patient who has received a preparation in a dose, exceeding recommended, should be under constant observation.
Treatment: in case of occurrence of a hypocalcemia with clinically significant implications carrying out of infusion of calcium of gluconat is shown.
Medicinal interaction
At simultaneous appointment with Zometa other often applied medical products (antitumoral agents, diuretics, antibiotics, analgetics) any clinically significant interactions it is noted.
It is recommended to be careful at simultaneous application aminoglycosides as both preparations can make additive impact on concentration of calcium in blood serum therefore calcium level in Serum can remain lowered is longer, than it is required.
Care is necessary at appointment with the preparations potentially possessing nephrotoxic action.
It is necessary to mean probability of development of a hypomagnesiemia.
Pharmaceutical interaction
Conditions and periods of storage
The preparation should be stored in a place inaccessible to children at temperature not above 30 C. The Period of validity - 3 years. The prepared solution can be stored in a refrigeration cabinet at temperature from 2 to 8 C no more than 24 h.
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