METHYLENE BLUE- methylene blue injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)

Available from:

General Injectables & Vaccines, Inc

INN (International Name):

METHYLENE BLUE

Composition:

METHYLENE BLUE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

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._
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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