Vidalta Tablets 15 mg (100 tablets)

Vidalta Tablets 15 mg (100 tablets)
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For Treatment of hyperthyroidism and hyperthyroidism-associated clinical signs in cats. Read more
Vidalta Tablets 15 mg (100 tablets)

For Treatment of hyperthyroidism and hyperthyroidism-associated clinical signs in cats.

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Product Description

About Vidalta Tablets 15 mg (100 tablets)

Vidalta Tablets 15 mg (100 tablets)

For Treatment of hyperthyroidism and hyperthyroidism-associated clinical signs in cats.

Please note: images are for illustration purposes only and pack sizes/strengths and new packaging styles may not be reflected in the image shown.

Directions For Use

Directions for Use

For oral use only.

Vidalta tablets should be administered at the same time every day, in particular in relation to timing of feeding. Vidalta may be given with food or on an empty stomach, as long as this is not varied from day to day.

Do not break or crush Vidalta tablets.

The aim of treatment is to maintain total thyroxine concentrations (TT4) in the lower end of the reference range. Accordingly, the following dose recommendations for dosing during adjustment and maintenance phases are suggested. However dosing adjustment should be primarily based upon the clinical assessment of the individual cat. Monitoring of TT4, full haematology and liver and kidney parameters is advised at each recommended follow up visit.

Adjustment phase

The starting dose is a single daily oral administration of one tablet of 15 mg carbimazole per cat. Consideration could be given to a starting dose of Vidalta 10 mg daily where the TT4 concentration is only mildly increased, e.g. between 50 nmol/L and 100 nmol/L.

With the recommended starting dose of one Vidalta 15 mg tablet once daily, total thyroxine concentration (TT4) may decrease to within the euthyroid range (TT4<50 nmol/L) shortly after treatment initiation. A dose adjustment may be required as early as 10 days of treatment.

Dose adjustment should also be performed 3, 5 and 8 weeks after initiation of treatment, depending on both clinical and hormonal responses to treatment.

Maintenance phase

Follow-up visits every 3 to 6 months are recommended. The dose should be adjusted individually based on clinical signs and total thyroxine concentration (TT4). It is advisable to check TT4 10-14 days after dose adjustment.

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 require doses of less than 10 mg carbimazole daily. In these cases, alternative treatment should be used.

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.

Active Ingredient

Vidalta Tablets 15 mg (100 tablets) ingredients

10 mg tablet: Round pink tablet with little spots. Each tablet contains 10 mg carbimazole as active ingredient. Colouring agent: Red ferric oxide (E172): 0.25 mg.

15 mg tablet: Round dark pink tablet with little spots. Each tablet contains 15 mg carbimazole as active ingredient. Colouring agent: Red ferric oxide (E172): 0.75 mg.

Side Effects

Side effects of Vidalta Tablets 15 mg (100 tablets)

Do not use in cats with haematological disorders, such as neutropenia, lymphopenia or thrombocytopenia.

Do not use in pregnant or lactating queens.

Do not use in cats with hypersensitivity to carbimazole.

Doses above 20 mg have only been trialled in a small number of cats. Adverse reactions may occur at this dose, therefore careful monitoring is recommended and the dose should be adjusted according to the risk/benefit assessment for the individual case.

Most frequent common adverse reactions include vomiting, diarrhoea, reduced appetite, as well as dermatological signs (pruritus, moist dermatitis, erythema, alopecia). These clinical signs are usually mild, adequately controlled by symptomatic therapy and do not require treatment discontinuation. Weight loss, dehydration, dyspnoea, lethargy, aggressiveness, disorientation, ataxia or pyrexia have also been reported in rare cases.

Treatment of hyperthyroidism may result in a reduction in the glomerular filtration rate. This can lead to unmasking of pre-existent renal dysfunction. Renal function should therefore be monitored (BUN and creatinine) before and during treatment, preferably at each visit of the dose adjustment and maintenance phases. The dose should be adjusted according to the risk/benefit assessment for the individual case.

Treatment of hyperthyroidism with carbimazole may also induce an elevation of liver enzymes (AP and ALT) or a worsening of pre-existing hepatic disorders. Liver enzymes should therefore be monitored before and during treatment, preferably at each visit of the dose adjustment and maintenance phases. Severe cases may require temporary or permanent treatment discontinuation. Liver enzyme elevations are usually reversible following drug discontinuation, although symptomatic therapy (nutritional and fluid support) may be required.

Transient anaemia, increase or decrease in white blood cell count, neutrophilia, thrombocytopenia, eosinophilia and/or lymphopenia may also occur. Haematology parameters should therefore be monitored on a regular basis before and during treatment, preferably at each visit of the dose adjustment phase and maintenance phase. Treatment discontinuation is not required except in case of persistent and marked disorder. In most cases, the abnormalities will resolve spontaneously within 1 month after treatment discontinuation.

In case of overdosage, adverse effects that may appear include, but are not limited to, weight loss, inappetence, vomiting and lethargy. Coat and skin abnormalities (erythema, hair loss), as well as haematological/biochemical changes (eosinophilia, lymphocytosis, neutropenia, lymphopenia, slight leucopenia, agranulocytosis, thrombocytopenia or haemolytic anaemia) may also appear. In particular, at a daily dose of 45 mg carbimazole, haematological changes (decreased red blood cell count, haemoglobin concentration and haematocrit, and increased mean corpuscular volume) have been reported in healthy cats. Hepatitis and nephritis have also been reported.

Total thyroxine concentrations (TT4) 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 in TT4. Dose adjustment should not be made based on TT4 only.

A small proportion of cats with thyroid adenoma may fail to respond or have a poor response to treatment. Thyroid carcinoma is a rare cause of hyperthyroidism in the cat and medical management alone is not recommended in such cases as it is not curative.

Additional Data

Vidalta Tablets 15 mg (100 tablets) specification

Specification: Detail:
Pack Size: 100 tablets
Brands: Intervet
Product Form: paste
External Link:

http://www.noahcompendium.co.uk/Intervet_Schering-Plough/documents/S6204.html

Strength/Size: 15 mg

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