Methylene blue 5 mg/mL
Methylene Blue · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Methylene blue is a prescription injection given intravenously that is used to treat methemoglobinemia, a serious condition where abnormal hemoglobin prevents blood from carrying oxygen effectively. It works by helping to convert the abnormal hemoglobin back to a form that can carry oxygen throughout your body.
Key Facts
- Brand Name
- Methylene blue
- Generic Name
- Methylene Blue
- NDC Code (Product)
0143-9094- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216959
- Marketing Start
- 06/05/2025
Recall History
Guardian Pharmacy Services
Lack of sterility assurance.
GenoGenix LLC
Lack of Assurance of Sterility
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Vilvet Pharmaceuticals Inc.
cGMP deviations
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Vilvet Pharmaceuticals Inc.
cGMP deviations
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Methylene Blue Injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Methylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer 1 mg/kg intravenously over 5-30 minutes. ( 2.1 ) If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose. ( 2.1 ) Administer a single dose of 1 mg/kg in patients with moderate or severe renal impairment. ( 2.2 ) 2.1 Dosage and Administration Ensure patent venous access prior to administration of methylene blue injection. Do not administer methylene blue injection subcutaneously. Administer methylene blue injection 1 mg/kg intravenously over 5-30 minutes. If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of methylene blue injection 1 mg/kg may be given one hour after the first dose. If methemoglobinemia does not resolve after 2 doses of methylene blue injection, consider initiating alternative interventions for treatment of methemoglobinemia. 2.2 Recommended Dosage for Renal Impairment The recommended dosage of methylene blue injection in patients with moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m 2 ) is a single dose of 1 mg/kg. If the methemoglobin level remains greater than 30% or if t…
Contraindications
4 CONTRAINDICATIONS 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 conditions ( 4 ): Severe hypersensitivity to methylene blue Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
Drug Interactions
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 monoamine oxidase. Avoid concomitant use of methylene blue injection with medicinal products that enhance serotonergic transmission including antidepressants like SSRIs (selective serotonin reuptake inhibitors), SNRIs (serotonin and norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome. If the intravenous use of methylene blue injection cannot be avoided in patients treated with serotonergic medicinal products, choose the lowest possible dose and observe the patient closely for CNS effects for up to 4 hours after administration [see Warning and Precautions (5.1) and Clinical Pharmacology (…
Adverse Reactions
6 ADVERSE REACTIONS 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 [see Warnings and Precautions (5.6) ] Interference with Laboratory Tests [see Warnings and Precautions (5.7) ] The most commonly reported adverse reactions (≥2%) included headache, hypokalemia, diarrhea, hypomagnesemia, myoclonus, nausea, and seizure-like phenomena. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect…
Frequently Asked Questions
What is Methylene blue used for?
Methylene blue is a prescription injection given intravenously that is used to treat methemoglobinemia, a serious condition where abnormal hemoglobin prevents blood from carrying oxygen effectively. It works by helping to convert the abnormal hemoglobin back to a form that can carry oxygen throughout your body.
Is Methylene blue a controlled substance?
Methylene blue is not classified as a controlled substance by the DEA.
What is the generic name for Methylene blue?
The generic name for Methylene blue is Methylene Blue. There are 8 other brand versions of Methylene Blue.
What is the NDC code for Methylene blue 5 mg/mL?
The NDC (National Drug Code) for Methylene blue 5 mg/mL is 0143-9094, listed by Hikma Pharmaceuticals USA Inc..