Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland
NeoMercazole 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:
NeoMercazole should only be administered if hyperthyroidism has been confirmed by laboratory tests.
The initial dose is in the range 20-60 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 5-15 mg per day, which may be taken as a single daily dose. Therapy should be continued for at least six, and up to eighteen months.
Serial thyroid function is recommended, together with appropriate dosage modification in order to maintain aeuthyroid state.
Blocking-replacement regimen: Dosage is maintained at the initial level, i.e. 20–60 mg per day, and supplemental l-thyroxine, 50–150 mcg per day, is administered concomitantly, in order to prevent hypothyroidism. Therapy should be continued for at least six months, and up to eighteen months.
Where a single dosage of less than 20 mg is recommended, it is intended that NeoMercazole 5 mg Tablets should be taken.
No special dosage regimen is required, but care should be taken to observe the contra-indications 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 and over).
Initial dosage for the treatment of children and adolescents above 3 years of age should be adjusted to the body weight of the patients. Usually treatment is initiated at a daily dose of 0.5 mg/kg, divided into two or three equal doses. For maintenance therapy, the daily dose can be reduced depending on the response of the patient to the treatment. Additional treatment with levothyroxine may be required to avoid hypothyroidism. A total daily dose of 40 mg carbimazole should not be exceeded.
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.
Oral.
No symptoms are likely from a single large dose.
No specific treatment is indicated.
3 years.
Do not store above 25°C. Store in the original container.
NeoMercazole 5 mg tablets are available in HDPE bottles with polypropylene tamper-evident screw cap with integrated desiccant. Each bottle contains 100 tablets.
No special requirements.
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