METHYLENE BLUE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHYLENE BLUE

Available from:

HIKMA CANADA LIMITED

ATC code:

V03AB17

INN (International Name):

METHYLTHIONINIUM CHLORIDE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

METHYLENE BLUE 10MG

Administration route:

INTRAVENOUS

Units in package:

250ML

Prescription type:

Ethical

Therapeutic area:

ANTIDOTES

Product summary:

Active ingredient group (AIG) number: 0106816001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-04-03

Summary of Product characteristics

Page 1 of 6
PRODUCT MONOGRAPH
METHYLENE BLUE INJECTION USP
1% w / v (10 mg / mL)
Sterile solution
Intravenous
METHEMOGLOBINEMIA / DIAGNOSTIC AID
Hikma Canada Limited
Date of Preparation:
5995 Avebury Road
April 14, 2022
Suite 804
Mississauga, Ontario
L5R 3P9
Control no. 262703
Page 2 of 6
METHYLENE BLUE INJECTION USP
(Tetramethylthionine Chloride Trihydrate)
THERAPEUTIC CATEGORY: METHEMOGLOBINEMIA/DIAGNOSTIC AID
Recent research has revealed that methylene blue has structural
properties similar to Monoamine
oxidase inhibitors (MAOI), known precipitants of serotonin toxicity
when administered
concomitantly with drugs having serotonin reuptake inhibition
properties (SRIs). Serotonin
toxicity/serotonin syndrome has been reported when methylene blue was
administered
intravenously at concentrations as low as 1 mg/kg, in patients
receiving Selective Serotonine
Reuptake Inhibitors (SSRIs) or other drugs with serotonine reuptake
inhibition properties (e.g.:
duloxetine, venlafaxine and clomipramine). Several of these cases
required admission to
Intensive Care Unit.
If SRIs are being taken, careful consideration needs to be given to
stop them before methylene
blue injectable use to allow a washout period equivalent to at least
4-5 half-lives.
ACTION AND PHARMACOLOGY:
Methylene blue activates a normally dormant reductase enzyme system
which reduces the
methylene blue to leucomethylene blue, which in turns is able to
reduce methemoglobin to
hemoglobin. Methylene blue is absorbed from the gastro-intestinal
tract. It is believed to be
reduced in the tissues to the leuco form which is slowly excreted,
mainly in the urine together
with some unchanged drug. Methylene blue imparts a blue colour to
urine and feces. In large
doses methylene blue can produce methemoglobinemia.
INDICATIONS AND CLINICAL USE:
Methylene Blue Injection USP is used in the treatment of
methemoglobinemia. Methylene Blue
Injection USP is also used as bacteriological stain, as a dye in
diagnostic procedures such as
fistula detection, and for the delineation of