Vinblatine 10 mg - Lyophiliced Vial
Chemotherapy drug to canine and feline with cancer.
Use in veterinary medicine
Made in Argentina
Description: Chemotherapy for dogs and cats. Composition: Vinblastine 10 mg Excipients authorized. c.s.
Action: Chemotherapy. The basic idea behind drugs of cancer chemotherapy is for them to reach areas of the body that are inaccessible to surgery and to kill only the cancer cells and leave alone the normal cells of the body.
Vinblastine Sulfate for Injection USP is vincaleukoblastine, sulfate (1:1) (salt). It is the salt of an alkaloid extracted from Vinca Rosea Linn., a common fl owering herb known as the periwinkle (more properly known as Catharanthus roseus G. Don). Previously, the generic name was vincaleukoblastine, abbreviated VLB. It is a stathmokinetic oncolytic agent. When treated
in vitro with this preparation, growing cells are arrested in metaphase.
Microtubule-disruptive drugs like vinblastine have been reported to act by two mechanisms. At very low concentrations they suppress microtubule dynamics and at higher concentrations they reduce microtubule polymer mass. Recent findings indicate that they also produce microtubule fragments by stimulating microtubule minus-end detachment from their organizing centers. Dose-response studies further indicate that enhanced microtubule detachment from spindle poles correlate best with cytotoxicity.
Dosage: The exact doses should be indicated and calculated by a diplomate veterinary oncology. General rule is Dogs: 2 mg/mt2.
Indicarions and usage: Vinblastine sulfate is indicated in the palliative treatment of the following:
Venereal Transmissible Tumor.
Mast cell tumor.
Convinated with other chemoteraphy drug in carcinoma protocol.
Convinated with other chemoteraphy drug in sarcoma protocol.
Administration: Vinblastine is a cytotoxic drug that is administered to cancer patients by the intravenous and, whenever appropriate, intravesical and intra-arterial routes. Intravenous (IV) Administration: Dosage is usually calculated on the basis of body surface area (mg/m2). The vinblatine dose-schedule to be delivered may differ depending on the therapeutic indication (e.g. solid tumours or acute leukaemias) as well as on its use within a specific regimen (e.g. as a single agent or in combination with other cytotoxics or as a part of multidisciplinary approaches which include combination with surgery and/or radiotherapy). Intravenous administration of vinblastine should be performed with caution. It is recommended to administer vinblastine into the tubing of a freely flowing IV infusion (isotonic sodium chloride or 5% glucose solution) over a period of 15 minutes.
Therapeutic regimen: The interval and numbers of cycles should be indicated by a diplomate veterinary oncology. General rule is between 21 days.
Pharmacokinetics: Pharmacokinetic studies in animals with cancer have shown a triphasic serum decay pattern following rapid intravenous injection. The initial, middle, and terminal half-lives are 3.7 minutes, 1.6 hours, and 24.8 hours, respectively. The volume of the central compartment is 70% of body weight, probably reflecting very rapid tissue binding to formed elements of the blood. Extensive reversible tissue binding occurs. Low body stores are present at 48 and 72 hours after injection. Since the major route of excretion may be through the biliary system, toxicity from this drug may be increased when there is hepatic excretory insufficiency. The metabolism of vinca alkaloids has been shown to be mediated by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily. This metabolic pathway may be impaired in animals with hepatic dysfunction or who are taking concomitant potent inhibitors of these isoenzymes such as erythromycin. Enhanced toxicity has been reported in patients receiving concomitant erythromycin. (See PRECAUTIONS). Following injection of tritiated vinblastine in human cancer patient, 10% of the radioactivity was found in the feces and 14% in the urine; the remaining activity was not accounted for.
Similar studies in dogs demonstrated that, over 9 days, 30% to 36% of radioactivity was found in the bile and 12% to 17% in the urine.
A similar study in the rat demonstrated that the highest concentrations of radioactivity were found in the lung, liver, spleen, and kidney 2 hours after injection.
Side effects: Hematologic Effects: Clinically, leukopenia is an expected effect of vinblastine sulfate, and the level of the leukocyte count is an important guide to therapy with this drug. In general, the larger the dose employed, the more profound and longer lasting the leukopenia will be. The fact that the white-blood-cell count returns to normal levels after drug-induced leukopenia is an indication that the white-cell-producing mechanism is not permanently depressed. Usually, the white count has completely returned to normal after the virtual disappearance of white cells from the peripheral blood.
Following therapy with vinblastine sulfate, the nadir in white-blood-cell count may be expected to occur 5 to 10 days after the last day of drug administration. Recovery of the white blood count is fairly rapid thereafter and is usually complete within another 7 to 14 days. With the smaller doses employed for maintenance therapy, leukopenia may not be a problem.
Although the thrombocyte count ordinarily is not significantly lowered by therapy with vinblastine sulfate, animals whose bone marrow has been recently impaired by prior therapy with radiation or with other oncolytic drugs may show thrombocytopenia (less than 200,000 platelets/mm3).
When other chemotherapy or radiation has not been employed previously, thrombocyte reduction below the level 200,000/mm3 is rarely encountered, even when vinblastine sulfate may be causing significant leukopenia. Rapid recovery from thrombocytopenia within a few days is the rule.
The effect of vinblastine sulfate upon the red-cell count and hemoglobin is usually insignificant when other therapy does not complicate the picture. It should be remembered, however, that patients with malignant disease may exhibit anemia even in the absence of any therapy.
Concerns and Cautions: As with all chemotherapy agents, vinblastine should not be used in pregnancy, lactation, or in animals to be used for breeding. Live vaccinations should not be given while the patient is on vinblastine. Vinblastine should be given IV; they are severe vesicants if administered perivascularly and may cause a severe, delayed phlebitis. Administration of a free radical inhibitor, dexrazoxane, may limit the extent of tissue damage seen with extravasation of this drug.
Contraindications: Hypersensitivity to vinblastine . Vinblastine therapy is also contraindicated in pregnancy and lactation.
Protective measures: The following protective recommendations are given due to the toxic nature of this substance. Personnel should be trained in good technique and handling; pregnant staff should be excluded from working with this drug; personnel handling doxorubicin should wear protective clothing: goggles, gowns and disposable gloves and masks; A designated area should be defined for reconstitution (preferably under a laminar flow system). The work surface should be protected by disposable, plastic-backed, absorbent paper. All items used for, administration or cleaning, including gloves, should be placed in high-risk waste-disposal bags for high-temperature incineration. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All cleaning materials should be disposed of as indicated previously. In case of skin contact thoroughly wash the affected area with soap and water or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with copious amounts of water for at least 15 minutes. Then seek medical evaluation by a physician. Always wash hands after removing gloves.
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