Methylene Blue

What is Methylene Blue and how is it used?

Methylene Blue is a prescription medicine used to treat the symptoms of Acquired Methemoglobinemia. Methylene Blue may be used alone or with other medications.

Methylene Blue belongs to a class of drugs called Antidotes, Other.

It is not known if Methylene Blue is safe and effective in children.

What are the possible side effects of Methylene Blue?

Methylene Blue may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• difficulty breathing,
• confusion,
• weakness,
• pale or yellowed skin,
• dark colored urine,
• fever,
• agitation,
• hallucinations,
• fever,
• fast heart rate,
• overactive reflexes,
• nausea,
• vomiting,
• diarrhea,
• loss of coordination, and
• fainting

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Methylene Blue include:

• pain in your arms or legs,
• blue or green urine,
• altered sense of taste,
• headache,
• dizziness,
• sweating,
• skin discoloration,
• nausea, and
• feeling hot

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Methylene Blue. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

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

C₁₆H₁₈C_lN₃S                   MW = 319.86

Each mL of solution contains 10 mg of methylene blue (methylene blue injection) .

INDICATIONS

Drug induced methemoglobinemia.

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 (methylene blue injection) intravenously very slowly over a period of several minutes.

HOW SUPPLIED

Methylene Blue (methylene blue injection) Injection, USP, 1% is supplied as follows:

NDC 11098-504-01

1 mL in 2 cc (partially filled) vials in packages of 10.

NDC 11098-504-10

10 mL vials in packages of 10.

NDC 11098-520-01 1 mL ampules in packages of 10.
NDC 11098-520-10 10 mL ampules 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.

Taylor Pharmaceuticals, An Akorn Company, Decatur, Illinois 62522. Rev. 03/06. FDA rev date: n/a

SIDE EFFECTS

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.

DRUG INTERACTIONS

No information provided.

WARNINGS

Methylene Blue (methylene blue injection) should not be given by subcutaneous or intrathecal injection.

PRECAUTIONS

Methylene Blue (methylene blue injection) 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.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Intraspinal injection is contraindicated.

CLINICAL PHARMACOLOGY

Actions

Methylene blue (methylene blue injection) 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.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.