Methylene Blue Injection

DESCRIPTION

Methylene Blue Injection, USP is a sterile solution of Phenothiazin-5-ium,3,7-bis (dimethylamino)-, chloride, trihydrate. Each mL contains 10 mg of Methylene Blue, USP in Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.

The molecular formula is: C₁₆H₁₈ClN₃S • 3H₂O and its molecular weight is 373.90.

CLINICAL PHARMACOLOGY

Methylene Blue 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.

INDICATIONS

Drug-induced methemoglobinemia.

DOSAGE AND ADMINISTRATION

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.

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

Store at controlled room temperature 15°- 30° C (59°- 86° F).

HOW SUPPLIED

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

WARNINGS

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

PRECAUTIONS

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.