You are here: Home > Prescription(RX) Drugs > M > Methylene Blue (General Injectables & Vaccines, Inc.)

Name:Methylene Blue
Manufacturer:General Injectables & Vaccines, Inc.
Category:Prescription Marketed Drugs


METHYLENE BLUE 10MG/ML

METHYLENE BLUE   - methylene blue injection, solution 
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 10MG/ML

DESCRIPTION

Methylene Blue Injection, USP is a sterile solution of Phenothiazin_5_ium, 3, 7-bis (dimethylamino)- chloride, trihydrate. Each mL contains Methylene Blue, USP, 10 mg in Water for Injection q.s.  pH adjusted with Hydrochloric Acid and /or Sodium Hydroxide when necessary.

The structural formula is:

Formula1                                                                                                                                                                                                                                              

CLINICAL PHARMACOLOGY

Methylene Blue is Phenothiazin-5ium, 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.

INDICATIONS AND USAGE

Drug-induced methemoglobinemia.

CONTRAINDICATION

Intraspinal injection is contraindicated.

WARNINGS

Methylene Blue should not be given by subcutaneous or intrathecal injection.

PRECAUTIONS

Methylene Blue 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.

ADVERSE REACTIONS

Large intravenous doses of Methylene Blue 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 in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

DOSAGE AND ADMINISTRATION

0.1 to 0.2 mL per kg body weight (0.045 to 0.09 mL per pound body weight). Inject Methylene Blue intravenously very slowly over a period of several minutes.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Store at 20 degrees-25 degrees C (68 degress-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) (See USP Controlled Room Temperature).

NDC 0517-0301-10
10 mg/ml
1ml Single Dose Vial packed in a box of 10
NDC 0517-0310-10
10mg/ml
10ml Single Dose Vial packed in a box of 10
NDC 0517-0372-71
10mg/ml
1ml Ampule packed in a box of 25
NDC 0517-0373-70
10mg/ml
10ml Ampule packed ina box of 25

Sample label

Label1

METHYLENE BLUE  
methylene blue injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-310(NDC:0517-0310)
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylene Blue (Methylene Blue) Methylene Blue 10 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-310-10 1 VIAL, SINGLE-DOSE ( VIAL) in 1 BAG contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-310-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/17/2010

Labeler - General Injectables & Vaccines, Inc. (108250663)

Revised: 01/2011 General Injectables & Vaccines, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback