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:

Akorn

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
AKORN
_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 INJECTION 1%
(FOR SLOW INTRAVENOUS ADMINISTRATION)
Rx only
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).
DESCRIPTION:
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 formula is:
The molecular formula is:
C
H
ClN S • 3H O MW = 373.90
CLINICAL PHARMACOLOGY:
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 AND USAGE:
16
18
3
2
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 patient becomes pregnant
whi