Active Ingredient: Tegomil fumarate
Tegomil fumarate is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient age in years is ≥ 13
Oral, 174 milligrams tegomil fumarate, 2 times daily, over the duration of 7 days. Afterwards, oral, 348 milligrams tegomil fumarate, 2 times daily.
The starting dose is 174 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 348 mg twice a day.
If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise, the patient should wait until the next scheduled dose.
Temporary dose reduction to 174 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 348 mg twice a day should be resumed.
Tegomil fumarate should be taken with food. For those patients who may experience flushing or gastrointestinal adverse reactions, taking tegomil fumarate with food may improve tolerability.
Clinical studies of tegomil fumarate had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
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