Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Methylthionine (methylene blue)

Generic name
Methylthionine (methylene blue)
Brand name
ATC Code
V03AB17

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Aniline or dapsone-induced methaemoglobinaemia
  • Intravenous
    • 3 months up to 18 years
      • 1 - 2 mg/kg/dose, bolus in 5 min. Maximum cumulative dose: 4 mg/kg.
      • Repeat after 1 hour if needed. 

    • Term neonate
      • 0.3 - 0.5 mg/kg/dose, bolus in 5 min.
      • Repeat after 1 hour if needed. 

    • 1 month up to 3 months
      • 0.3 - 0.5 mg/kg/dose, bolus in 5 min.
      • Repeat after 1 hour if needed. 

    • 3 months up to 18 years
      [2]
      • 1 - 2 mg/kg/dose, bolus in 5 min. Maximum cumulative dose: 4 mg/kg.
      • Repeat after 1 hour if needed. 

    • Term neonate
      [2]
      • 0.3 - 0.5 mg/kg/dose, bolus in 5 min.
      • Repeat after 1 hour if needed. 

    • 1 month up to 3 months
      • 0.3 - 0.5 mg/kg/dose, bolus in 5 min.
      • Repeat after 1 hour if needed. 

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Renal impaiment in children > 3 months

  • eGFR 60-89 ml/min/1.73m2: dose adjustment not required
  • eGFR 30-59 ml/min/1.73m2: 1-2 mg/kg/dose. Repeat if necessary. Maximum cumulative dose: 2 mg/kg/day
  • eGFR 15-29 ml/min/1.73m2: single dose of 1 mg/kg/dose. Maximum cumulative dose: 1 mg/kg/day


Infants < 3 months: 

  • eGFR 15-59 ml/min/1.73m2: use with caution, as no data are available and methylthioninium chloride is excreted primarily renally. Lower maximum cumulative doses (< 0.5 mg/kg body weight) may be considered.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effects in children are similar to those in adults. Hyperbilirubinaemia is reported in infants. 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Can cause haemolysis. Children younger than 3 months have lower levels of NADPH-methaemoglobin reductase, making them more susceptible to methaemoglobinaemia caused by high doses of methylthionine.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Antidotes
V03AB27
V03AB16
V03AB24
V03AB25
V03AB33
V03AB15
V03AB13
V03AB19
V03AB14
V03AB06
V03AB35
Iron chelating agents
V03AC03
V03AC02
V03AC01
Drugs for treatment of hyperkalemia and hyperphosphatemia
V03AE07
V03AE01
V03AE02
V03AE01
Detoxifying agents for antineoplastic treatment
V03AF03
V03AF01
V03AF07
Drugs for treatment of hypoglycemia
V03AH01
Other therapeutic products
V03AX03
DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
V03AF03
V03AF01
V03AF07
OTHER THERAPEUTIC PRODUCTS
V03AX03

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References

  1. Driscoll W, et al, Effect of methylene blue on refractory neonatal hypotension, J Pediatr, 1996, Dec;129(6), 904-8
  2. PROVEPHARM SAS, SmPC Methylthionine Proveblue (EU/1/11/682) REV 25; 15-12-2022, https://www.ema.europa.eu

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Changes

Changes