Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methylene Blue Injection, USP 1% is supplied as follows: NDC 54288-147-01 10 mL single dose vial per carton. To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs LLC at 727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .; PRINCIPAL DISPLAY PANEL Vial Label: Methylene Blue Injection, USP 1% NDC 54288-147-01 LI147L-01 R-2503 Carton Label: Methylene Blue Injection, USP 1% NDC 54288-147-01 LI147C-01 R-2401 Vial Label Carton Label
- HOW SUPPLIED Methylene Blue Injection, USP 1% is supplied as follows: NDC 54288-147-01 10 mL single dose vial per carton. To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs LLC at 727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- PRINCIPAL DISPLAY PANEL Vial Label: Methylene Blue Injection, USP 1% NDC 54288-147-01 LI147L-01 R-2503 Carton Label: Methylene Blue Injection, USP 1% NDC 54288-147-01 LI147C-01 R-2401 Vial Label Carton Label
Overview
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 sodium hydroxide and/or hydrochloric acid when necessary. The structural formula is: The molecular formula is: C 16 H 18 ClN 3 S • 3H 2 O MW = 373.90 structure
Indications & Usage
Drug-induced methemoglobinemia
Dosage & 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. 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.
Warnings & Precautions
WARNINGS 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.
Boxed 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, Drug Interactions).
Contraindications
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.
Storage & Handling
STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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