Your browser does not support JavaScript! METHYLENE BLUE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

METHYLENE BLUE injection, solution
[General Injectables & Vaccines, Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

Description

Methylene Blue Injection, USP is a sterile solution of methylene blue in water for injection suitable for parenteral administration.


Formula1

C16H18ClN3S                         MW = 319.86

Each mL of solution contains 10 mg of methylene blue.

Actions

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.

Indications

Drug induced methemoglobinemia.

Contraindications

Intraspinal injection is contraindicated.

Warnings

Methylene Blue should not be given by subcutaneous or intrathecal injection.

Precautions

Methylene Blue must be injected intravenously very slowly over a period of several minutes to prevent local high concentration of the compound from producing additional methemoglobin. Do not exceed recommended dosage.

Adverse Reactions

Large intravenous doses of Methylene Blue produce nausea, abdominal and precordial pain, dizziness, headache, profuse sweating, mental confusion and the formation of methemoglobin.

Use in Pregnancy

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.

Dosage and Administration

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.

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Flip Tear-Off Seal: Directions for Use:
1. With the thumb, flip the plastic button up to reveal the rubber stopper.
2. Pull the button to tear the seal at the score line and twist to remove.

Manufactured by:

Akorn, Inc.
Lake Forest, IL 60045

MB00N

Rev. 08/08

Sample Outer Label

Label

METHYLENE BLUE 
methylene blue injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:52584-504(NDC:17478-504)
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methylene Blue (Methylene Blue) Methylene Blue10 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52584-504-101 in 1 BAG
110 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2010
Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 8/2010
 
General Injectables & Vaccines, Inc

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services