Vidalta 15mg (30 Tablets)
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|Drug Name and Strength||Carbimazole 15mg|
|Indication||Treatment of hyperthyroidism and hyperthyroidism associated clinical signs in cats.|
|Contraindications||Do not use in cats with haematological disorders such as anaemia, neutropenia, lymphopenia, thrombocytopenia or coagulopathies; concurrent systemic diseases such as severe primary liver disease or diabetes mellitus; signs of autoimmune disease; hypersensitivity to mercaptoimidazoles (carbimazole or methimazole).|
|Actions||Pharmacology Carbimazole is the prodrug of thiamazole (methimazole). Although carbimazole has inherent antithyroid activity, it is almost totally converted to thiamazole soon after oral administration to humans and cats. Thiamazole results in dose dependent inhibition of the thyroid peroxidase catalysed reactions involved in thyroid hormone synthesis, including oxidation of iodide and iodination of tyrosyl residues in thyroglobulin, thereby inhibiting neosynthesis of thyroid hormones. Thiamazole also interferes with the coupling of iodotyrosines to iodothyronines via inhibition of thyroid peroxidase or by binding and altering the structure of thyroglobulin. This reaction is more sensitive to inhibition than the formation of iodotyrosines. The inhibitory action of thiamazole is reversible. Thiamazole does not inhibit the action of thyroid hormones already formed and present in the thyroid glands or bloodstream, or interfere with the effectiveness of administered exogenous thyroid hormone (iatrogenic hyperthyroidism). This explains why the length of the latency period until normalisation of serum concentrations of thyroxine and triiodothyronine, and thus to clinical improvement, differs between individuals.|
|Precautions||Not to be used in pregnant or lactating queens. Concomitant treatment with benzimidazole anthelminthics (fenbendazole or mebendazole) has been shown to reduce the hepatic oxidation of this therapeutic class and may lead to increases in circulating levels. Carbimazole may display immunomodulating properties and this should be taken into account when considering vaccination programs. Concomitant treatment with phenobarbitone may reduce the clinical efficacy of carbimazole. Administration of glucocortoicoids, dephenylhydantoin, phenobarbital and sulphonamide may decrease serum T4 concentrations. Therefore, concomitant treatment with carbimazole should be considered with caution.Do not break or crush tablets.Warning. Carbimazole may cause birth defects. Women of child bearing age are advised to wear protective gloves to prevent direct contact with the product, vomitus, faeces and urine of treated cats and/or when cleaning up broken or moistened tablets. Children and pregnant women should not come into contact with this drug. Keep children and pregnant women away from vomitus, faeces and urine of treated cats. Do not handle this product if you are allergic to hyperthyroidism inhibitors. Vidalta should be kept out of the reach and sight of children. Wash hands with soap and water after handling litter used by treated animals. Do not eat, drink or smoke while handling the tablet or used litter.First Aid If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126. In the case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.Disposal Dispose of empty packaging by wrapping with paper and putting in garbage.|
|Dosage and Administration||For oral use only. Vidalta tablets should be administered at the same time every day, in particular with relation to feeding. Do not break or crush the tablets as this will affect the sustained release property. The aim of treatment is to maintain the TT4 at the lower end of the reference range, and following dose recommendations for dosing during adjustment and maintenance phases are suggested. However dosing adjustment should be primarily based on the clinical assessment of the individual cat. Monitoring of TT4, full haematology and liver and kidney parameters is advised at each recommended followup visit.Adjustment phase. Starting dose. Give a single daily oral administration of 1 tablet of carbimazole 15 mg per cat. Consideration could be given to a starting dose of Vidalta 10 mg daily when the TT4 concentration is only mildly increased, e.g. between 50 nanomol/L and 100 nanomol/L. With the recommended starting dose of 1 Vidalta 15 mg tablet once daily, the TT4 may decrease to within the euthyroid range (TT4 < 50 nanomol/L) shortly after treatment initiation. Dose adjustment. A dose adjustment may be needed as early as day 10 of treatment. Dose adjustment should be also performed three, five and eight weeks after initiation of treatment, depending on both clinical and hormonal responses to treatment.Maintenance phase. Follow-up visits every three to six months are recommended. The dose should be adjusted individually, based on clinical signs and TT4. It is advisable to check TT4 10 to 14 days after dose adjustment. Treatment of hyperthyroidism may also induce an elevation of liver enzymes or a worsening of pre-existing hepatic disorders. Renal and liver function should therefore be monitored before and during treatment. Due to the risk of leukopenia or haemolytic anaemia, haematological parameters should be monitored regularly before and during treatment, preferably at each consultation in the dose adjustment and maintenance phases. Any animal that suddenly appears unwell during therapy, particularly if they are febrile, should have a blood sample taken for routine haematological and biochemical tests. The therapeutic dose of Vidalta ranges between 10 mg (one 10 mg tablet) and 25 mg (one 10 mg tablet and one 15 mg tablet) once daily. Some cats need doses of less than 10 mg carbimazole daily. Every other day dosing with carbimazole 10 mg or 15 mg of may be sufficient to control the disease. Dose increases should not be made in increments of greater than 5 mg. Doses above 20 mg have only been trialled in a small number of cats and should be used with caution. Safety data indicate that the margin of safety of the formulation in cats is narrow. TT4s below the lower limit of the reference range may be observed during treatment although this is rarely linked to overt clinical signs. Decreasing the dose will lead to an increase of the TT4. Dose adjustment should not be made based on TT4 only.|
|Storage||Store below 25°C (air conditioning). The tablets should be dispensed in their original packs. Protect from humidity and light. Keep the plastic container tightly closed to protect from moisture. Do not remove the desiccant.|
|MSDS (external link)||Vidalta MSDS|
|Label (external link)||Vidalta Label|
|Manufacturer||MSD Animal Health|