Methylene blue injection

Large intravenous doses of Methylene Blue (methylene blue injection) 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 (methylene blue injection) in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

Your doctor or pharmacist can provide more information about methylene blue.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Because you will receive methylene blue in a clinical setting, you are not likely to miss a dose.

WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS

Methylene Blue Injection may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs. Avoid concomitant use of Methylene Blue Injection with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (see WARNINGS and PRECAUTIONS,DRUGINTERACTIONS).

(FOR SLOW INTRAVENOUS ADMINISTRATION)

Rx Only

Methylene Blue Injection is a sterile solution of Phenothiazin-5-ium, 3, 7-bis (dimethylamino)-, chloride, trihydrate. Each mL contains methylene blue, 10 mg in water for injection q.s. pH adjusted with hydrochloric acid and/or sodium hydroxide when necessary.

The structural formual is:

The molecular formula is:

C16H18ClN3S • 3H2O                        MW = 373.90

Drug induced methemoglobinemia.

Applies to methylene blue: intravenous solution

Along with its needed effects, methylene blue 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 while taking methylene blue:

• Agitation
• bluish-colored lips, fingernails, or palms
• 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
• tightness in the chest
• 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 while taking methylene blue:

• Abdominal or stomach pain
• 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
• 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
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Some side effects of methylene blue 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:

• 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
• pain in the arms or legs

• 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

Ifosfamide-induced encephalopathy (unlabeled use): (Treatment may not be necessary; encephalopathy may improve spontaneously)

Prevention: 50 mg every 6 to 8 hours

Treatment: 50 mg as a single dose or every 4 to 8 hours until symptoms resolve

Data not available

Administer undiluted by direct IV injection over 5 to 10 minutes to prevent local high concentration of the compound from producing additional methemoglobin.

For the treatment of ifosfamide-induced encephalopathy, methylene blue may be administered either undiluted as a slow IV push over at least 5 minutes or diluted in 50 mL NS or D5W and infused over at least 5 minutes. Consider concomitant dextrose administration, especially in patients who are hypoglycemic, to ensure efficacy of methylene blue.

Do not exceed recommended dosage. Large intravenous doses of methylene blue produce nausea, abdominal and precordial pain, dizziness, headache, profuse sweating, mental confusion and the formation of methemoglobin.

Intraspinal and subcutaneous injections are contraindicated. Methylene blue should not be given by intrathecal injection.