Country: Canada
Language: English
Source: Health Canada
METHYLENE BLUE
PHEBRA PTY LTD
V03AB17
METHYLTHIONINIUM CHLORIDE
10MG
SOLUTION
METHYLENE BLUE 10MG
INTRAVENOUS
15G/50G
Ethical
ANTIDOTES
Active ingredient group (AIG) number: 0106816001; AHFS:
APPROVED
2019-04-30
Methylene Blue Injection 1% w/v Page 1 of 4 PRESCRIBING INFORMATION METHYLENE BLUE INJECTION 1% W/V (10 MG/ML) STERILE SOLUTION _British Pharmacopoeia _(B.P.)_ _ Methemoglobinemia / Diagnostic Aid Phebra Pty Ltd 19 Orion Road Lane Cove West Australia, 2066 Canadian Importer: ICON Plc 4 Innovation Drive Dundas, Ontario L9H 7P3 Date of Preparation: April 30, 2019 Submission Control No: 222283 Methylene Blue Injection 1% w/v Page 2 of 4 PRESCRIBING INFORMATION METHYLENE BLUE INJECTION 10 MG/ML METHEMOGLOBINEMIA DIAGNOSTIC AID L.V. PHARMACOLOGY Methylene Blue activates a normally dormant reductase enzyme system which reduces the methylene blue to leucomethylene blue, which in turn is able to reduce methemoglobin to hemoglobin. Methylene Blue is absorbed from the gastrointestinal tract. It is believed to be reduced in the tissue to the Ieuco form which is slowly excreted, mainly in the urine together with some unchanged drug. Methylene Blue imparts a blue colour to urine and faeces. In large doses Methylene Blue can produce methemoglobinemia. INDICATIONS Used in the treatment of methemoglobinemia. Also used as a bacteriological stain, as a dye in diagnostic procedures such as fistula detection, and for the delineation of certain body tissues during surgery. CONTRAINDICATIONS In patients with severe renal impairment or a known hypersensitivity to the drug. PRECAUTIONS Methemoglobin concentration should be closely monitored during treatment as Methylene Blue can produce methemoglobinemia in large doses. Methylene Blue should be used with caution in the treatment of toxic methemoglobinemia; high doses can cause hemolytic anemia and patients with glucose- 6-phosphate dehydrogenase (G6PD) deficiencies are particularly susceptible. A rapid disappearance of cyanosis in response to Methylene Blue would be expected within one hour but might not occur if the patient has erythrocyte G6PD or NADPH- diaphorase deficiency or if methemoglobinemia is due to the ingestion of compounds such as aniline or dapsone. A second dose has been Read the complete document