Zometa

Зомета Drug photo

The description is actual on 11.06.2015

  • Latin name: Zometa
  • ATH code: M05BA08
  • Active ingredient: Zoledronovy acid *
  • Producer: Novartis Pharma Stein AG (Switzerland)

Structure

In 1 bottle of 5 ml — monohydrate of zoledronovy acid of 4,264 mg.

Release form

Ready solution for infusions in a bottle of 4 mg / 100 ml.

Concentrate for preparation of solution for intravenous infusions of 4 mg / 5 ml.

Pharmacological action

Inhibits a bone resorption. Adjusts a metabolism of a bone tissue.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Zoledronovy acid — highly effective bisfosfonat, slowing down a bone resorption, influencing osteoclasts which destroy a bone tissue.

The selection action on a bone tissue is explained by high affinity to it. Bisfosfonata are absorbed by osteoclasts only in places of change of a bone. Then osteoclasts slow down the action on a bone tissue, and process of its destruction stops. However, some details of the mechanism of effect of drug are not found out up to the end.

Zoledronovy acid has high antirezorbtsionny activity. At use for persons with postmenopauzny osteoporosis reliable decrease in risk of fractures of vertebras and repeated fractures of vertebras was noted. At treatment of patients with Pedzhet's illness the authentic, long medical answer, normalization of concentration of ShchF and level of a bone exchange is observed. At patients with these diseases drug does not influence a condition of a normal bone, promotes preservation of its very tectonics and does not break processes of a mineralization.

Besides, drug, suppressing proliferation of cells, has antineoplastic effect at a myeloma and a tumor of a mammary gland. Possesses anti-metastatic properties that allows to apply in the presence of bone metastasises and to their prevention. The inhibition of a resorption of a bone leads to considerable reduction of pain.

At an oncopathology with metastatic damage of bones drug prevents development of changes and squeezing of a spinal cord, reduces a tumoral hypercalcemia and removal of calcium with urine. In bigger quantity of cases the need for radiation therapy decreases.

Pharmacokinetics

Biphosphonates are badly soaked up in a gastrointestinal tract therefore it is more reasonable to apply solutions to intravenous administration. After infusion serumal concentration increase, and reach peak by the end of infusion. In 4 h there is a reduction of concentration by 10%, and after 24 h for 1%. Linkng with proteins of plasma makes 50%.

Zoledronovy acid is removed by kidneys in several stages and final T1/2 makes 146 h. At repeated introductions (in 28 days) cumulation is not noted. In the first days in urine 40±16% of a dose are found. The rest of drug is postponed in a bone tissue and slowly released in a system blood stream. Is not exposed to a metabolism and in not changed look it is removed by kidneys, with a stake — less than 3%.

Indications to use

Zometa is applied at:

  • secondary pathology a bone tissue (metastasises) at widespread tumors (cancer milk and a prostate);
  • to multiple myeloma;
  • hypercalcemias of tumoral genesis and at a hyperparathyreosis;
  • to prevention of pathological changes;
  • to prevention of a compression of a rachis;
  • surgical interventions on a bone;
  • to prevention of osteoporosis against treatment of an oncopathology of a mammary gland aromatase inhibitors.

Contraindications

  • hypersensitivity to bisfosfonata and zoledronovy acid;
  • pregnancy;
  • lactation;
  • the expressed renal failure (at clearance of creatinine of ≤30 ml/min.);
  • children's age.

With care appoint at a renal failure and a liver failure, aspirinovy bronchial asthma.

Side effects

Often met undesirable reactions:

  • fever and grippopodobny syndrome;
  • headache;
  • conjunctivitis;
  • anemia;
  • nausea, vomiting, lack of appetite;
  • ostealgia and joints;
  • renal failures;
  • hypophosphatemia, hypocalcemia, increase of concentration of creatinine and urea.

Seldom met reactions:

  • dizziness, confusion of consciousness, feeling of alarm, tremor, frustration of a dream;
  • leukopenia, pancytopenia;
  • sight illegibility, uveitis;
  • diarrhea, lock, abdominal pains, stomatitis, dryness in a mouth;
  • short wind, cough;
  • itch, rash;
  • muscular spasms;
  • increase or decrease in the ABP, bradycardia;
  • hamaturia, proteinuria, OPN;
  • adynamy, hypostases, increase in weight;
  • hypomagnesiemia, hypopotassemia, hypernatremia.

Development of drowsiness, fibrillation of auricles, bronchospasm, acute anaphylaxis and the small tortoiseshell was seldom or never observed.

The instruction on Zometa (A way and a dosage)

The drug concentrate (4 mg / 5 ml) is parted in 100 ml of solution of sodium of chloride or solution of a dextrose and used right after preparation. Infusion is carried out within 15 minutes. The prepared solution is allowed to be stored at a temperature of 2-8 °C within a day. Solution cannot be mixed with other HP and it is necessary to enter, using separate system for infusions.

At metastasises in a bone of widespread tumors and a multiple myeloma the dose of 4 mg of times is appointed 3–4 weeks.

For prevention of osteoporosis and pathological changes at an oncopathology of a mammary gland during treatment by aromatase inhibitors in a postmenopause — 4 mg of 1 times in 6 months.

The application instruction of Zometa contains the warning that during treatment it is necessary to carry out a constant control of minerals, creatinine and urea to blood. Level of creatinine is controlled before each injection.

Overdose

Acute overdose of drug is shown by a renal failure (even development of OPN), change of electrolytic composition of blood (magnesium, calcium, phosphates).

At clinically significant hypocalcemia infusions of a gluconate of calcium are shown.

Interaction

Co-administration of aminoglycosides and zoledronovy acid increases risk of development of a hypocalcemia.

It is not necessary to appoint drug with the HP possessing nephrotoxic action.

 The risk of emergence of renal failures and OPN at patients with a multiple myeloma increases in a combination with a thalidomide.

Chemical incompatibility of solution of Zometa and Ringer's solution is noted.

Terms of sale

According to the recipe.

Storage conditions

At a temperature up to 30 °C.

Period of validity

3 years.

Zometa's analogs

Coincidence on the ATH code of the 4th level:

Zometa and her analogs (structural) have one active ingredient - it is Rezoskan, Zolendronik-Rus 4, Aklasta, Blaztera, Zoledronovaya acid, Zoleriks, Zoledreks, Zoledronat-Teva, Rezoklastin FS, Rezorba, Veroklast,

What Zometa or Rezorba is better?

If to compare these drugs, then they have one active ingredient in an identical dosage. On action and efficiency are identical. Drugs differ only in the producer: The Rezorba — generic which is issued in Russia (CJSC F-Sintez) therefore the price is slightly lower. Cost of 1 bottle of 6139-8139 rub. If you give preference to original drugs, then it is worth making a choice for Zomet.

Rezoklastin or Zometa: what it is better?

Too most it is possible to tell if to compare Zometa and Rezoklastin (the producer of CJSC F-Sintez, Russia). There is no basic difference. Is issued in the form of a concentrate of two dosages — 4 mg and 5 mg of zoledronovy acid. The estimated cost of one bottle of 4300 rub, however, at the moment drug is absent in pharmacy chain.

It should be noted that all these drugs belong to aminobisfosfonata and "simple" bisfosfonata possess more expressed action, than (Clodronate, Etidronat, Didronel). They are not acquired by osteoclasts and therefore have the additional effect which is expressed in bigger antirezorbtsionny effect.

About Zometa

Zoledronovy acid at the moment is the most powerful bisfosfonat. It is quite often used at osteoporosis in the post-menopausal period. Increase in density of vertebrae of lumbar department and a neck of a hip at Zometa's use within a year was noted — drug on 4 mg once, on 2 mg 2 times a year or on 1 mg 4 times a year was used. This drug treat as well the secondary osteoporosis caused by metastatic process.

At clinical tests drug showed the best efficiency in treatment of a number of oncological diseases, and is recommended for use in oncology. It is suggested that blocking of a resorption of a bone tissue can affect positively a cancer progression in general, extension of remission of a breast cancer after surgical or beam treatment.

Meet About Zometa, connected with existence of side reactions more often. Intravenously used bisfosfonata after the first introduction caused temperature increase, muscular pains, a febricula and grippopodobny symptoms which did not repeat at the subsequent introductions.

"Put a dropper with Zometoy-temperature rose, the state was as at flu! Transferred the subsequent droppers normally, after them felt much better — pains decreased, calcium is normal"

In isolated cases the jaw osteonecrosis after a recent odontectomy at patients who received high doses of infusional bisfosfonat was noted.

Zdravzona

  • Zometa a concentrate for No. 1 solution 4mg/5ml preparation flakonnovartis Farm
  • Zometa a concentrate for No. 1 solution 4mg/100ml preparation flakonnovartis Farm

Drugstore of IFC

  • Zometa of konts-t for preparation of solution for inf. 4mg/5ml No. 1, Novartis Pharmashveytsariya
to show still

Apteka24

  • Zometanovartis Pharma Stein (Switzerland)
Section: For joints Antineoplastic
in more detail

Education: Graduated from Sverdlovsk medical school (1968 - 1971) as "Paramedic". Graduated from the Donetsk medical institute (1975 - 1981) as "An epidemiologist, a hygienist". Passed postgraduate study in the Central scientific research institute of epidemiology Moscow (1986 - 1989). An academic degree – the candidate of medical sciences (degree is awarded in 1989, protection – the Central scientific research institute of epidemiology Moscow). Numerous advanced training courses are studied in epidemiology and infectious diseases.

Experience: Work as the manager of department of disinfection and sterilization of 1981 - 1992. Work as the manager of department of especially dangerous infections of 1992 - 2010. Teaching activity at Medical institute 2010 - 2013.

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