Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)
General Injectables & Vaccines, Inc
METHYLENE BLUE
METHYLENE BLUE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 Injection, 1% is supplied as follows: NDC 17478-504-01 1 mL in 2 cc (partially filled) vials in packages of 10. NDC 17478-504-10 10 mL vials 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.
unapproved drug other
METHYLENE BLUE- METHYLENE BLUE INJECTION GENERAL INJECTABLES & VACCINES, INC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- METHYLENE BLUE 10 MG/ML INJECTION, USP 10 ML SINGLE DOSE VIAL DES CRIPTION 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,DRUGINTERACTIONS). (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 formual is: The molecular formula is: C H ClN S • 3H O MW = 373.90 ACTIONS 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) INDICATIONS Drug induced methemoglobinemia. 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 patie Citiți documentul complet