Methylene blue

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Methylene blue
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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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 {{{adverseReactions}}}.

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)

There is limited information regarding Methylene blue FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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.

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 Methylene blue Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Methylene blue Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Safety for use in pregnancy has not been established. Use of Methylene Blue in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
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

There is no FDA guidance on the use of Methylene blue in patients with 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

There is limited information regarding Methylene blue Administration in the drug label.

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

There is limited information regarding Methylene blue Mechanism of Action in the drug label.

Structure

There is limited information regarding Methylene blue Structure in the drug label.

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.