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Methylene blue

Class
Oxidizing agents
Subclass
NADPH-MetHb reductase stimulants
Generic name
Methylene blue, methylthioninium chloride
Brand names
Provayblue®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of methemoglobinemia • Drug-induced
•
0.1-0.2 mL/kg IV once
Other off-label uses
•
Adjunctive treatment for septic shock
Indications for use
Labeled indications
Adults
•
Treatment of methemoglobinemia (drug-induced)
Off-label indications
Adults
•
Adjunctive treatment for septic shock
Safety risks
Contraindications
G6PD deficiency
Severe hypersensitivity reactions to methylene blue or any other thiazine dye
The concomitant use of methylene blue with SSRIs, SNRIs, and MAOIs
Warnings and precautions
Hemolysis
•
Use caution with a history of anemia or other blood cells related disorders.
Specific populations
Renal impairment
eGFR ≥ 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 15-59 mL/min/1.73 m²
•
Maximal dose of 1 mg/kg. Monitor serum concentrations. eGFR 15 to 59 mL/minute/1.73 m2: Single dose of 1 mg/kg IV; if the methemoglobin concentration remains greater than 30% or if the clinical symptoms persist 1 hour after dosing, consider initiating alternative interventions for the treatment of methemoglobinemia.
Renal replacement therapy
Continuous renal replacement
•
Maximal dose of 1 mg/kg. Monitor serum concentrations.
Intermittent hemodialysis
•
Maximal dose of 1 mg/kg. Monitor serum concentrations.
Peritoneal dialysis
•
Maximal dose of 1 mg/kg. Monitor serum concentrations.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Methylene blue is contraindicated in women who are or may become pregnant. Methylene blue may cause fetal harm when administered during pregnancy.
•
Epidemiologic evidence exists that methylene blue is a teratogen. Intra-amniotic injection of pregnant women with methylene blue during the second trimester was associated with neonatal intestinal atresia and fetal death.
•
Methylene blue should not be administered during amniocentesis due to the risk of teratogenicity and other newborn adverse effects. Intra-amniotic injection of methylene blue hours to days prior to birth can result in hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress, and photosensitivity in the neonate.
•
If methylene blue is administered to a pregnant woman at term, monitor the neonate for adverse reactions. If methylene blue is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the woman of the potential risk to the fetus.
Breastfeeding
Little information available on breastfeeding safety.
•
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Common 1-10%
•
↓ serum magnesium, ↓ serum potassium, myoclonus, diarrhea, headache, nausea, seizure
Unknown frequency
•
Allergic reactions, anaphylaxis, angioedema, cardiac arrhythmias, death, hemolysis, hemolytic anemia, hypertension, hypotension, ↑ liver enzymes, ↑ serum TBIL, photosensitivity of skin, blurred vision, dry mouth, dysuria, flatulence, ↑ thirst, injection site reactions, itchy eyes, lower abdominal pain, myalgia, nasal congestion, nasal discharge, palpitations, sneezing, throat pain, tongue pain, serotonin syndrome, skin edema, skin papules, tachycardia, tongue abnormality, urticaria
Interactions
Drug(s)
Check Interactions
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