Methylene Blue (AFT)
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
20-12-2010
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Active ingredient:
Methylthioninium chloride trihydrate 10 mg/mL
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Methylthioninium chloride trihydrate 10 mg/mL
Dosage:
50 mg/5mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Methylthioninium chloride trihydrate 10 mg/mL Excipient: Water for injection
Units in package:
Ampoule, glass, 5 x 5mL, 25 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
BDH Chemicals (Australia) Ltd
Product summary:
Package - Contents - Shelf Life: Ampoule, glass, 5 x 5mL - 25 mL - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
1985-10-31
Summary of Product characteristics
METHYLENE BLUE SOLUTION FOR INJECTION
METHYLTHIONINIUM CHLORIDE TRIHYDRATE 10MG/ML
NAME OF DRUG
The active ingredient of Methylene Blue Solution for Injection is
methylene blue
trihydrate (3,7-Bis(dimethylamino)phenazathionium chloride
trihydrate).
PRESENTATION
Methylene Blue Solution for Injection is a clear, blue-coloured
solution containing in
each 5.0 mL glass ampoule, methylene blue trihydrate 50.0 milligrams
and water for
injections. The pH of the solution ranges between 3.0 and 4.5.
USES
_ACTIONS _
In patients with methaemoglobinaemia, therapeutic doses of methylene
blue can
lower the levels of methaemoglobin in red blood cells. It activates a
normally dormant
reductase enzyme system that reduces the methylene blue to
leucomethylene blue,
which in turn is able to reduce methaemoglobin to haemoglobin.
However, in large
doses, methylene blue can itself produce methaemoglobinaemia and the
methaemoglobin concentration should therefore be closely monitored
during
treatment. Methylene blue is not effective for the treatment of
methaemoglobinaemia
in patients with glucose-6-phosphate dehydrogenase deficiency as
these patients
have a diminished capacity to reduce methylene blue to leucomethylene
blue. It is
also potentially harmful as patients with glucose-6-phosphate
dehydrogenase
deficiency are particularly susceptible to the haemolytic anaemias
induced by
methylene blue.
Methylene blue also possesses weak antiseptic and bacteriological
staining
properties and is reported to inhibit amine oxidase in tissues. The
drug appears to
bind irreversibly to viral nucleic acid and cause disruption of the
virus molecule upon
exposure to light.
The use of methylene blue as a diagnostic aid is based on its
ability to stain tissue.
Any skin discolouration can be removed with hypochlorite solution.
_PHARMACOKINETICS _
In tissues, methylene blue is rapidly reduced to leucomethylene blue,
which is
stabilised a
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