Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Carbimazole is an anti-thyroid agent. It is indicated in adults and children in all conditions where reduction of thyroid function is required.
Such conditions are:
Carbimazole should only be administered if hyperthyroidism has been confirmed by laboratory tests.
No special dosage regimen is required, but care should be taken to observe the contraindications and warnings as it has been reported that the risk of a fatal outcome to neutrophil dyscrasia may be greater in the elderly (aged 65 or over).
The usual initial daily dose is 15 mg per day adjusted according to response.
Safety and efficacy of carbimazole in children below 2 years of age have not been evaluated systematically. Use of carbimazole in children below 2 years of age is therefore not recommended.
The initial dose is in the range 20 mg to 60 mg, taken as two to three divided doses. The dose should be titrated against thyroid function until the patient is euthyroid in order to reduce the risk of over-treatment and resultant hypothyroidism.
Subsequent therapy may then be administered in one of two ways.
Maintenance regimen:
Final dosage is usually in the range 5 mg to 15 mg per day, which may be taken as a single daily dose. Therapy should be continued for at least six months and up to 18 months. Serial thyroid function monitoring is recommended, together with appropriate dosage modification in order to maintain a euthyroid state.
Blocking-replacement regimen:
Dosage is maintained at the initial level, i.e. 20 mg to 60 mg per day, and supplemental L-thyroxine, 50 mcg to 150 mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should be continued for at least six months and up to 18 months. Where a single dosage of less than 20 mg is recommended, it is intended that carbimazole 5 mg tablets should be taken.
Oral.
No symptoms are likely from a single large dose.
No specific treatment is indicated.
3 years.
Do not store above 25°C. Store the blisters in the original package.
The tablets are supplied in white, opaque 250 micron thermoformed PVC blister packs sealed with 20 micron lacquered aluminium foil containing 28, 56, 100 or 112 tablets.
Not all pack sizes may be marketed.
The heatseal coating lacquer of the aluminium foil consists of a PVC/PVAC co-polymer and polymethacrylate, with the outer side being a heat resistant lacquer based on polyester.
No special requirements.
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