Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
METHYLENE BLUE
HIKMA CANADA LIMITED
V03AB17
METHYLTHIONINIUM CHLORIDE
10MG
SOLUTION
METHYLENE BLUE 10MG
INTRAVENOUS
250ML
Ethical
ANTIDOTES
Active ingredient group (AIG) number: 0106816001; AHFS:
APPROVED
2020-04-03
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 Đọc toàn bộ tài liệu