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Methylene blue (injection)

متیلن بلو (تزریقی)

⚠ Unverified

🧪 VariousMethaemoglobinaemia antidote

🤰 Pregnancy:Dangerous / avoid 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications ⚠️ 1 interactions 🇺🇸 FDA approved (NDA) NDA204630 ATC V03AB17

Market / country: 🇺🇸 USA

ProvayBlue (US)

🧮 Dose calculator

Disease / regimen

Methaemoglobinaemia · Regimen source: FDA ProvayBlue · 2.1

• If methaemoglobin stays >30% or symptoms persist, one more 1 mg/kg after 1 h; after 2 doses use other treatment. Moderate–severe renal impairment: single dose only. Dilute in D5W, not saline; never subcutaneous. FDA ProvayBlue · 2.1 FDA ProvayBlue · 2.2 FDA ProvayBlue · 2.3

Formulation

Age *

Weight (kg) *

Enter age and weight.

🛡️ Safety & information

Contraindications

⛔ Severe hypersensitivity to methylene blue or thiazine dyes; G6PD deficiency (haemolysis). FDA ProvayBlue · 4

Warnings

• Boxed warning: serotonin syndrome with SSRIs, SNRIs, MAOIs and opioids — avoid concomitant use. FDA ProvayBlue · Boxed Warning

Important interactions

• SSRIs, SNRIs, MAOIs and opioids: serious or fatal serotonin syndrome. FDA ProvayBlue · Boxed Warning

Formulations

5 mg/mL (10 mg/2 mL; 50 mg/10 mL) — injection 🇺🇸 USA FDA ProvayBlue · 3

👥 Special populations

🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA ProvayBlue · 8.1
“Risk Summary PROVAYBLUE may cause fetal harm when administered to a pregnant woman.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA ProvayBlue · 8.2
“Risk Summary There is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA ProvayBlue · 8.4
“The safety and effectiveness of PROVAYBLUE for the treatment of acquired methemoglobinemia have been established in pediatric patients.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA ProvayBlue · 8.5
“Clinical studies of PROVAYBLUE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA204630
DailyMed (FDA label)FDA ProvayBlue
MedlinePlus (NIH)❌ None
WHO ATC/DDDV03AB17
Darooyab (Iran)Methylene-Blue

🇮🇷 Registered in Iran Darooyab · G-1965/Methylene-Blue

Dosage forms with Iranian generic codes, per Darooyab.

01589 · METHYLENE BLUE 100MG/10ML AMP · آمپول متیلن بلو ۱۰۰ میلی‌گرم / ۱۰ میلی‌لیتر
05979 · METHYLENE BLUE 50MG/5ML AMP · آمپول متیلن بلو ۵۰ میلی‌گرم / ۵ میلی‌لیتر
51920 · METHYLENE BLUE INJECTION PARENTERAL 10 mg/1mL 1 mL · فرآورده تزریقی متیلن بلو ۱۰ میلی‌گرم / ۱ میلی‌لیتر ۱ میلی‌لیتر

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA ProvayBlue · 3 FDA ProvayBlue · 2.1 FDA ProvayBlue · 2.2 FDA ProvayBlue · 2.3 FDA ProvayBlue · 4 FDA ProvayBlue · Boxed Warning FDA ProvayBlue · 8.1 FDA ProvayBlue · 8.2 FDA ProvayBlue · 8.4 FDA ProvayBlue · 8.5 FDA ProvayBlue · SPL approval / marketing category
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-1965/Methylene-Blue
Clinical review⚠ Unverified