Label: METHYLENE BLUE - methylene blue injection, solution 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/10

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  • 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.

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  • 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.

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  • Indications

    Drug induced methemoglobinemia.

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  • Contraindications

    Intraspinal injection is contraindicated.

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  • Warnings

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

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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

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  • Sample Outer Label
  • INGREDIENTS AND APPEARANCE
    METHYLENE BLUE 
    methylene blue injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52584-504(NDC:17478-504)
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Methylene Blue (Methylene Blue) Methylene Blue 10 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52584-504-10 1 in 1 BAG
    1 10 mL in 1 VIAL, SINGLE-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/01/2010
    Labeler - General Injectables & Vaccines, Inc (108250663)
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