Provayblue (Intravenous)

Methylene blue injection is used to treat a condition called methemoglobinemia. This condition happens 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.

Your doctor will closely monitor your progress while you are receiving this medicine. This will help your doctor determine if the medicine is working as it should. Blood tests may be necessary to check for any unwanted effects.

Using this medicine during pregnancy can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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

This medicine may lead to a condition known as serotonin syndrome when taken with certain other medicines (e.g., SSRIs, TCAs, MAOIs). Contact your doctor immediately if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or if you see or hear things that aren’t there.

Before undergoing any medical tests, inform the doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

This medicine may cause dizziness, confusion, or difficulties with clear vision. Be aware of how you respond to this medicine before driving, operating machinery, or performing tasks that require alertness or good vision.

This medicine may increase your skin's sensitivity to sunlight. Use sunscreen when outdoors. Avoid sunlamps and tanning beds.

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

In deciding to use a medicine, you and your doctor will need to consider the risks of taking it versus the benefits it may provide. Here are some important points to think about:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research has not shown any problems specific to children that would limit the use of methylene blue injection in young patients. Its safety and effectiveness have been confirmed.

Geriatric

Research has not indicated any problems specific to the elderly that would limit the use of methylene blue injection in older patients. However, elderly patients are more likely to have kidney issues, which may require careful monitoring and a possible dose adjustment for those receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction could happen. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may alter 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
• Doxepin
• Doxylamine
• Duloxetine
• Entacapone
• Escitalopram
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Gepirone
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levodopa
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Meperidine
• Methamphetamine
• Methylphenidate
• Milnacipran
• Mirtazapine
• Nortriptyline
• Ozanimod
• Paroxetine
• Phenelzine
• Phentermine
• Protriptyline
• Pseudoephedrine
• Rizatriptan
• Safinamide
• Selegiline
• Serdexmethylphenidate
• Sertraline
• Solriamfetol
• Sumatriptan
• Tapentadol
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Viloxazine
• Vortioxetine
• Zolmitriptan

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

• Albuterol
• Alfentanil
• Almotriptan
• Alprazolam
• Amineptine
• Amitriptylinoxide
• Atropine
• Benzhydrocodone
• Bromazepam
• Brompheniramine
• Buprenorphine
• Buspirone
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Cetirizine
• Chlorpheniramine
• Clobazam
• Clonazepam
• Cocaine
• Daridorexant
• Dexmedetomidine
• Dextromethorphan
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Eletriptan
• Epinephrine
• Esketamine
• Fentanyl
• Flibanserin
• Formoterol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Granisetron
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Ketamine
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levorphanol
• Lithium
• Lofepramine
• Lofexidine
• Lorcaserin
• Loxapine
• Magnesium Oxybate
• Melitracen
• Metaxalone
• Methadone
• Metoclopramide
• Midodrine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Norepinephrine
• Olanzapine
• Ondansetron
• Opipramol
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Procarbazine
• Rasagiline
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Tianeptine
• Topiramate
• Valbenazine
• Vilanterol
• Ziprasidone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary condition that affects red blood cells)—This medicine should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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 right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have 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.

In the U.S.

• Provayblue

Available Dosage Forms:

• Solution

Therapeutic Class: Antidote

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.

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