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:

BPI LABS LLC

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   54288-159-05 Five 2 mL Single-Dose Prefilled Syringes packed in a 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 .

Authorization status:

unapproved drug other

Summary of Product characteristics

METHYLENE BLUE- METHYLENE BLUE INJECTION
BPI LABS LLC
_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 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 sodium hydroxide and/or
hydrochloric acid 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 p