Methylene Blue Generic Name: methylene blue injection Brand Name: Methylene Blue side effects drug center methylene blue (methylene blue injection) drug Related Drugs Azactam Injection Cyanokit Provayblue Health Resources Urinary Tract Infection (UTI) Related Supplements Cranberry Melatonin PROFESSIONAL CONSUMER SIDE EFFECTS Contents Drug Description Indications & Dosage Side Effects & Drug Interactions Warnings & Precautions Overdosage & Contraindications Clinical Pharmacology Medication Guide Drug Description 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. C16H18ClN3S MW = 319.86 Each mL of solution contains 10 mg of methylene blue (methylene blue injection) . Indications & Dosage 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: With the thumb, flip the plastic button up to reveal the rubber stopper. 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 & Drug Interactions 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 & Precautions 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. Overdosage & Contraindications OVERDOSE No information provided. CONTRAINDICATIONS Intraspinal injection is contraindicated. Clinical Pharmacology 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. Medication Guide PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
