Proveblue

Proveblue

methylthioninium chloride

Manufacturer:

Provepharm

Distributor:

Summit

Marketer:

Pharm-D
Concise Prescribing Info
Contents
Methylthioninium Cl
Indications/Uses
Drug & chemical products-induced methaemoglobinaemia. Dye in diagnostic procedures & for delineation of certain body tissues during surgery.
Dosage/Direction for Use
IV Adult & childn Acute methaemoglobinaemia 1-2 mg/kg over 5 min, may repeat dose after 1 hr if required. Max: 7 mg/kg. Staining & identification of parathyroid glands 5 mg/kg diluted in glucose 5% 500 mL infused over 1 hr. Adult, adolescent, childn & infant >4 mth w/ moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m2) Acquired methaemoglobinemia 1-2 mg/kg as single dose. Max: 2 mg/kg.
Contraindications
Hypersensitivity to methylthioninium Cl or any other thiazine dyes. G6PD & nicotinamide adenine dinucleotide phosphate reductase deficiency; nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning; methaemoglobinaemia due to chlorate poisoning.
Special Precautions
Not to be inj by SC or intrathecally. Aniline-induced methaemoglobinaemia, dapsone-induced haemolytic anaemia; hyperglycaemia or DM; cytochrome b5 reductase & G6PD deficiency or sulfhaemoglobinemia. May cause bispectral index interference in patients receiving dapsone therapy. False estimation of O2 saturation w/ use of pulse oximetry. Monitor ECG & BP levels during & after treatment. Frequently check Hb conc & monitor methaemoglobin level during therapy. May impart blue-green colour to urine, stool & blue colour to skin. Avoid exposure to strong light sources eg, phototherapy, operating theatres or illuminating devices eg, pulse oximeters. Long-term use. Avoid concomitant use w/ SSRIs, SNRIs, MAOIs. May affect ability to drive & use machines. Hepatic & moderate or severe renal impairment; ESRD w/ or w/o dialysis. May affect male & female fertility. Not to be used during pregnancy & lactation. Not recommended in infants <4 mth.
Adverse Reactions
Dizziness, paraesthesia, dysgeusia; nausea; skin discoloration, sweating; chromaturia; pain in extremity. Headache, anxiety; vomiting, abdominal pain; chest & inj site pain.
Drug Interactions
Enhanced serotonergic transmission w/ SSRIs, bupropion, buspirone, clomipramine, mirtazapine, venlafaxine. Transient increased exposure of cimetidine, metformin, acyclovir.
MIMS Class
Antidotes & Detoxifying Agents / Radiographic & Diagnostic Agents
ATC Classification
V03AB17 - methylthioninium chloride ; Belongs to the class of antidotes. Used in the management of prilocaine overdose.
Presentation/Packing
Form
Proveblue soln for inj 5 mg/mL
Packing/Price
10 mL x 5 × 1's
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