Proveblue Dosage/Direction for Use

Proveblue may be administered orally or by intravenous (IV) injection.
In the treatment of acute methaemoglobinaemia, the IV route of administration is usually preferred because it provides a more rapid onset of effect.
Adults and children: In the treatment of methaemoglobinaemia, methylene blue is administered intravenously as the 0.5% solution in doses of 1 to 2 mg per kg bodyweight injected over a period of 5 minutes. A repeat dose may be given after one hour if required. A maximum dose of 7 mg/kg bodyweight is recommended. The use of methylene blue is not recommended in infants under 4 months of age.
A dose of 5 mg/kg diluted in 500 mL of glucose 5% infused over 1 hour has been used successfully to stain and identify the parathyroid glands.
For the treatment of acute methaemoglobinaemia, Proveblue should not be diluted with sodium chloride 0.9% (saline) as precipitation may occur (due to presence of chloride ions which have been shown to reduce the solubility of methylene blue).
A suitable dilution for oral dosing would be 10-20 mL of the 0.5% solution diluted to 100-200 mL with water for injections. The high volume is suggested to reduce the degree of gastrointestinal disturbances and dysuria. The dosage of methylene blue should be calculated on the basis of lean body weight.
Use immediately following dilution.
The Proveblue ampoules should be inspected visually prior to administration. The product should not be used if the solution is discoloured, cloudy, turbid or if a precipitate or particles are present.
Each ampoule is for single use in one patient only. Discard any residue. Proveblue contains no antimicrobial agents
Renal impairment: In infants above 4 months , children and adolescents and in adults, the recommended dosage for the treatment of acquired methaemoglobinemia in patient with moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m2) is a single dose of 1 to 2 mg/kg per body weight with a maximum recommended cumulative dose for the course of treatment of 2 mg/kg.
No dose adjustment is recommended in patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m2).
The safety and efficacy of methylthioninium chloride in patients with end stage renal disease with and without dialysis has not yet been established. No data are available.
Hepatic impairment: The safety and efficacy of methylthioninium chloride in patients with hepatic impairment has not yet been established.
No data are available.
Treatment does not usually exceed one day.
It must not be administered by subcutaneous or intrathecal injection.
For instructions on handling and dilution of the medicinal product before administration, see Special Precautions for Disposal and Other Handling under Cautions For Usage.