Methylene blue (intravenous route)


    Brand Name

    US Brand Name

    Provayblue


    Description

    Methylene blue injection is used to treat a condition called methemoglobinemia. This condition occurs when the blood cannot deliver oxygen where it is needed in the body.

    This medicine is to be given only by or under the supervision of a doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylene blue injection in children. Safety and efficacy have been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methylene blue injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Amitriptyline
    • Amoxapine
    • Amphetamine
    • Atomoxetine
    • Benzphetamine
    • Bupropion
    • Carbamazepine
    • Carbidopa
    • Carbinoxamine
    • Citalopram
    • Clomipramine
    • Codeine
    • Cyclobenzaprine
    • Desipramine
    • Desvenlafaxine
    • Deutetrabenazine
    • Dexmethylphenidate
    • Dextroamphetamine
    • Dihydrocodeine
    • Doxepin
    • Doxylamine
    • Duloxetine
    • Entacapone
    • Escitalopram
    • Fenfluramine
    • Fluoxetine
    • Fluvoxamine
    • Gepirone
    • Hydroxytryptophan
    • Imipramine
    • Isocarboxazid
    • Levodopa
    • Levomilnacipran
    • Linezolid
    • Lisdexamfetamine
    • Maprotiline
    • Meperidine
    • Methamphetamine
    • Methylphenidate
    • Milnacipran

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Albuterol
    • Alfentanil
    • Almotriptan
    • Alprazolam
    • Amineptine
    • Amitriptylinoxide
    • Anileridine
    • Atropine
    • Benzhydrocodone
    • Bromazepam
    • Brompheniramine
    • Buprenorphine
    • Buspirone
    • Butalbital
    • Butorphanol
    • Calcium Oxybate
    • Cannabidiol
    • Cannabis
    • Cetirizine
    • Chlorpheniramine
    • Clobazam
    • Clonazepam
    • Cocaine
    • Daridorexant
    • Dexmedetomidine
    • Dextromethorphan
    • Diacetylmorphine
    • Diazepam
    • Dibenzepin
    • Difenoxin
    • Diphenoxylate
    • Dolasetron
    • Eletriptan
    • Epinephrine
    • Esketamine
    • Ethylmorphine
    • Fentanyl
    • Flibanserin
    • Formoterol
    • Frovatriptan

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acarbose
    • Chlorpropamide
    • Glimepiride
    • Glipizide
    • Glyburide
    • Insulin
    • Insulin Aspart, Recombinant
    • Insulin Bovine
    • Insulin Degludec
    • Insulin Detemir
    • Insulin Glargine, Recombinant
    • Insulin Glulisine
    • Insulin Lispro, Recombinant
    • Metformin
    • Nateglinide
    • Repaglinide
    • Tolazamide
    • Tolbutamide

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—Should not be used in patients with this condition.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 5 to 30 minutes.


    Precautions

    Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening require immediate medical attention. Check with your doctor right away if you have cough, difficulty swallowing, dizziness, fast heartbeat, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

    This medicine may cause a condition called serotonin syndrome when used together with some medicines (eg, SSRIs, TCAs, MAOIs). Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.

    Before you have any medical tests, tell the doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

    This medicine may cause dizziness, confusion, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert or able to see well.

    This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Agitation
    • bluish-colored lips, fingernails, or palms
    • chest tightness
    • confusion
    • cough
    • dark urine
    • diarrhea
    • difficulty breathing
    • difficulty swallowing
    • dizziness or lightheadedness
    • fast heartbeat
    • fever
    • headache
    • hives or welts, itching, or skin rash
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • overactive reflexes
    • pale skin
    • poor coordination
    • rapid heart rate
    • redness of the skin
    • restlessness
    • shivering
    • sore throat
    • sweating
    • talking or acting with excitement you cannot control
    • trembling or shaking
    • twitching
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Bigger, dilated, or enlarged pupils (black part of the eye)
    • blue staining of the urine, skin, and mucous membranes
    • bluish-colored lips, fingernails, or palms
    • blurred vision
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • chest tightness
    • confusion
    • dark urine
    • difficulty breathing
    • dizziness or lightheadedness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fear
    • fever
    • headache
    • increased sensitivity of the eyes to light
    • nausea
    • pale skin
    • rapid heart rate
    • rapid shallow breathing
    • shakiness in the legs, arms, hands, or feet
    • sore throat
    • stomach pain
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Arm or leg pain
    • change in taste
    • changes in skin color
    • feeling hot or cold
    • increased sweating
    • loss of taste
    • muscle or joint pain
    • pain at the infusion site

    Less common

    • Back pain
    • bruising
    • chills
    • general feeling of discomfort or illness
    • large, flat, blue or purplish patches in the skin
    • loss of appetite
    • muscle aches and pains
    • muscle spasm
    • runny nose
    • trouble sleeping

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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