(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 formula is:

The molecular formula is:

C16H18ClN3S ∙ 3H2O       MW = 373.90

Methylene blue 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.

Methylene blue is metabolized in the body to leukomethylene blue which is excreted primarily in the urine. Some unchanged drug is also excreted in the urine. (1)

Drug-induced methemoglobinemia.

Methylene blue can cause fetal harm when administered to a pregnant woman. An association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions, and other adverse effects in the neonate. (2, 3) Methylene blue is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Intraspinal and subcutaneous injections are contraindicated.

Methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

Methylene blue is a potent monoamine oxidase inhibitor: Methylene blue has been demonstrated to be a potent monoamine oxidase inhibitor (MAOI) and may cause potentially fatal serotonin toxicity (serotonin syndrome) when combined with serotonin reuptake inhibitors (SRIs). (4) (See Drug Interactions.) Serotonin toxicity is characterized by development of neuromuscular hyperactivity (tremor, clonus, myoclonus and hyperreflexia, and, in the advanced stage, pyramidal rigidity); autonomic hyperactivity (diaphoresis, fever, tachycardia, tachypnoea, and mydriasis); and altered mental status (agitation, excitement, and in the advanced stage, confusion). If methylene blue is judged to be indicated, SRIs must be ceased, prior to treatment/procedure/surgery.

0.1 to 0.2 mL per kg body weight (0.045 to 0.09 mL per pound body weight). Inject methylene blue intravenously very slowly over a period of several minutes.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

To report SUSPECTED ADVERSE REACTIONS, contact: Cameron Pharmaceuticals, LLC at 1-888-296-9383 (or FDA 1-800-FDA-1088) or through email at www.fda.gov/medwatch.

Methylene Blue Injection, 1%, USP is supplied as follows:

NDC 42494-419-05

10 mL vials in packages of 5.

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.

Manufactured for: Cameron Pharmaceuticals, LLC.

Rev. 05/23

NDC 42494-419-05

Methylene Blue 1%
Injection, USP

1% (10mg/mL)
For slow Intravenous administration
Rx only

5 x 10ml Single Dose Vials

Each mL contains:
Methylene Blue 10 mg and Water
for Injection q.s. pH adjusted with
Hydrochloric Acid and/or Sodium
Hydroxide when necessary.

Usual Dosage:
See package insert
for dosage information

Manufactured for:
Cameron Pharmaceuticals, LLC

EXP: 07/2023
LOT: 21VMBI024