METHYLENE BLUE

The mean (CV%) C max and AUC of methylene blue 2,917 ng/mL (39%) and 13,977 ng

• hr/mL (21%) following a 2 mg/kg dose administered as a 5-minute intravenous infusion.

DistributionThe mean± standard deviation steady state volume of distribution of a 2 mg/kg dose of methylene blue injection was 255 L ± 58. The mean plasma protein binding of methylene blue is approximately 94% in vitro . Methylene blue exhibits concentration-dependent partitioning into blood cells in vitro . The blood-to-plasma rati...

14.1 Treatment of Acquired Methemoglobinemia The efficacy of methylene blue injection in the treatment of patients with methemoglobinemia was evaluated in 24 adult patients with acquired methemoglobinemia: in study NCT03542760, a prospective, multicenter, observational registry. Of the 24 subjects enrolled 92% were white, 8% were black, 67% were female, and 33% were male. Hispanic or Latino was 12.5%; non-Hispanic or Latino was 87.5%, and ethnicity data were missing for 0%. The mean age was 46.0 years, and the ages ranged from 19 to 72 years. Each individual received at least 1 intravenous dos...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Serotonin Syndrome with Concomitant Use of Serotonergic Drugs [see Warnings and Precautions (5.1) ] Anaphylaxis [see Warnings and Precautions (5.2) ] Lack of Effectiveness [see Warnings and Precautions (5.3) ] Hemolytic Anemia [see Warnings and Precautions (5.4) ] Interference with In Vivo Monitoring Devices [see Warnings and Precautions (5.5) ] Effects on Ability to Drive and Operate Machinery [se...

Methylene blue injection is contraindicated in the following conditions: Severe hypersensitivity reactions to methylene blue or any other thiazine dye [see Warnings and Precautions (5.2) ] . Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia [see Warnings and Precautions (5.3 , 5.4 )] . Methylene blue injection is contraindicated in the following ...

Hypersensitivity: If severe or life threatening allergic reaction occurs, discontinue methylene blue injection, treat the allergic reaction, and monitor until signs and symptoms resolve. ( 5.2 ) Lack of Effectiveness: Consider alternative treatments if there is no resolution of methemoglobinemia after 2 doses. ( 2.1 , 5.3 ) Hemolytic Anemia: Discontinue methylene blue injection and transfuse. ( 5.4 ) Interference with In Vivo Monitoring Devices: Use methods other than pulse oximetry to assess ox...

7 DRUG INTERACTIONS Clinically significant drug interactions with methylene blue injection are described below: The concomitant use of methylene blue injection with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Although the mechanism is not clearly understood, literature reports suggest methylene blue is a potent reversible inhibitor of monoam...