Methylene blue
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Methylene blue is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of Drug induced methemoglobinemia. Common adverse reactions include Hypertension, hypotension, sweating symptom, abdominal pain, diarrhea, nausea, vomiting, dizziness, headache and confusion.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Drug induced methemoglobinemia
Dosage
- 0.1 to 0.2 mL per kilogram of body weight (0.045 to 0.09 mL per pound of body weight). Inject Methylene Blue intravenously very slowly over a period of several minutes.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Methylene blue in adult patients.
Non–Guideline-Supported Use
- There is limited information regarding Off-Label Non–Guideline-Supported Use of Methylene blue in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Methylene blue in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Methylene blue in pediatric patients.
Contraindications
- Intraspinal injection is contraindicated.
Warnings
- Methylene Blue should not be given by subcutaneous or intrathecal injection.
- Methylene blue is a potent monoamine oxidase inhibitor: Methylene blue has been demonstrated to be a potent monoamine oxidase inhibitor (MAOI) and may cause potentially fatal serotonin toxicity (serotonin syndrome) when combined with serotonin reputake inhibitors (SRIs). (4) Serotonin toxicity is characterized by development of neuromuscular hyperactivity (tremor, clonus, myoclonus and hyperreflexia, and, in the advanced stage, pyramidal rigidity); autonomic hyperactivity (diaphoresis, fever, tachycardia, tachypnoea, and mydraisis); and altered mental status (agitation, excitement, and in the advanced stage, confusion). If methylene blue is judged to be indicated, SRIs must be ceased, prior to treatment/procedure/surgery.
Precautions
- Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD): Methylene blue should be avoided in patients with G6PD deficiency due to the risk of paradoxical methemoglobinemia and hemolysis.
Adverse Reactions
Clinical Trials Experience
- Large intravenous doses of Methylene Blue produce nausea, abdominal and precordial pain, dizziness, headache, profuse sweating, mental confusion and the formation of methemoglobin.
Postmarketing Experience
- There is limited information regarding postmarketing experience
Drug Interactions
- Methylene blue may interact with any drug that acts as a serotonin reuptake inhibitor (SRI) including, amongst others, selective serotonin reuptake inhbitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), norepinephrine-dopamine reuptake inhibitors (NDRIs), triptans and ergot alkaloids; such combinations may have the consequence of potentially fatal serotonin toxicity (serotonin syndrome). Methylene blue should not be co-administered with any drug that acts as an SRI.
Use in Specific Populations
Pregnancy
- Epidemiologic evidence exists that Methylene blue is a teratogen. An association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. Methylene blue Injection should not be administered to pregnant women during amniocentesis due to the risk of teratogenicity and other newborn adverse effects
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Methylene blue in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Methylene blue during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Methylene blue in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Methylene blue in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Methylene blue in geriatric settings.
Gender
There is no FDA guidance on the use of Methylene blue with respect to specific gender populations.
Race
There is no FDA guidance on the use of Methylene blue with respect to specific racial populations.
Renal Impairment
- Renal Failure: Methylene blue should be used with caution in patients with severe renal impairment .
Hepatic Impairment
There is no FDA guidance on the use of Methylene blue in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Methylene blue in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Methylene blue in patients who are immunocompromised.
Administration and Monitoring
Administration
- Intravenous.
Monitoring
There is limited information regarding Methylene blue Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Methylene blue and IV administrations.
Overdosage
There is limited information regarding Methylene blue overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Methylene blue Pharmacology in the drug label.
Mechanism of Action
- Methylene blue is Phenothiazin-5-ium, 3,7-bis (dimethylamino)-, chloride, trihydrate. It will produce two opposite actions on hemoglobin. Low concentrations will convert methemoglobin to hemoglobin. High concentrations convert the ferrous iron of reduced hemoglobin to ferric iron which results in the formation of methemoglobin.
Structure
- Methylene Blue Injection, USP is a sterile solution of methylene blue in water for injection suitable for parenteral administration.
- Each mL of solution contains 10 mg of methylene blue and water for injection q.s. pH adjusted with hydrochloric acid and/or sodium hydroxide when necessary.
Pharmacodynamics
There is limited information regarding Methylene blue Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Methylene blue Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Methylene blue Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Methylene blue Clinical Studies in the drug label.
How Supplied
Methylene Blue Injection, USP, 1% is supplied as follows:
NDC 17478-504-01 1 mL in 2 cc (partially filled) vials in packages of 10.
NDC 17478-504-10 10 mL vials in packages of 10.
The vials are packaged with a Flip Tear-Off Seal. The seal can either be flipped normally to reveal the rubber stopper or be totally removed so the rubber stopper can be taken out of the vial. The plastic button is attached to the metal seal, which when pulled, tears the seal at the score line allowing the metal portion to be removed.
Storage
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Methylene blue Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Methylene blue interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Methylene blue Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Methylene blue Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.