Methylene Blue Injection, USP 1%
(FOR INTRAVENOUS INJECTION)
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) .
What are the possible side effects of methylene blue (Urolene Blue)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe nausea, vomiting, or stomach pain;
- pain in your chest or behind your breast bone;
- pale or blue skin;
- high fever, fast or pounding heartbeats, trouble breathing; or
- confusion, feeling like you might pass out.
Less serious side effects may include:
- mild bladder...
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.
Methylene Blue (methylene blue injection) Injection, USP, 1% is supplied as follows:
1 mL in 2 cc (partially filled) vials in packages of 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.
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
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.
No information provided.
Methylene Blue (methylene blue injection) should not be given by subcutaneous or intrathecal injection.
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.
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.