Active Ingredient: Methylthioninium chloride
Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1 - 7 mg per kg of body weight
From 1 To 7 mg per kg of body weight once every day
The usual dose is 1 to 2 mg per kg body weight, given over a period of 5 minutes. A repeat dose (1 to 2 mg/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range. Treatment does not usually exceed one day. The maximum recommended cumulative dose for the course of treatment is 7 mg/kg and should not be exceeded, since methylthioninium chloride administered above the maximum dose may cause methaemoglobinaemia in susceptible patients.
In the case of aniline- or dapsone-induced methaemaglobinaemia, the maximum recommended cumulative dose for the course of treatment is 4 mg/kg.
Too limited data are available to support a continuous infusion dose recommendation.
No dose adjustment is necessary.
Infants above 3 months, children and adolescents: Same posology as for adults.
For intravenous use.
Methylthioninium chloride is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
It must be injected very slowly over a period of 5 minutes.
It must not be administered by subcutaneous or intrathecal injection.
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