Methylthioninium Chloride Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Methylthioninium chloride 1%{relative} ((as the trihydrate))

Available from:

Max Health Limited

INN (International Name):

Methylthioninium chloride 1% w/v ((as the trihydrate))

Dosage:

1% w/v

Pharmaceutical form:

Solution for injection

Composition:

Active: Methylthioninium chloride 1%{relative} ((as the trihydrate)) Excipient: Water for injection

Units in package:

Ampoule, glass, 10x10ml, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Garuda Chemicals

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10x10ml - 100 mL - 60 months from date of manufacture stored at or below 25°C

Authorization date:

2006-03-03

Summary of Product characteristics

NEW ZEALAND DATA SHEET 

NAME OF THE MEDICINE 
Methylthioninium Chloride Injection USP 1% w/v containing Methylthioninium 
Chloride USP 
1% w/v 

PRESENTATION 
A dark blue liquid. 
Sterile aqueous injection containing Methylthioninium Chloride 1% w/v. 

USES 
_Actions _
_In-vivo, _in low concentration, Methylthioninium Chloride speeds up the conversion of 
methaemoglobin to haemoglobin. 
_Pharmacokinetics _
After i.v. administration Methylthioninium Chloride is rapidly taken up by the tissues. 
It is also well absorbed by the oral route. The majority of the dose is excreted in the 
urine, usually in the form of leuco Methylthioninium Chloride. 
_Indications _
Drug induced methaemoglobinaemia 

DOSAGE AND ADMINISTRATION 
Inject Methylthioninium Chloride very slowly over several minutes. 
Route of administration: Intravenous Injection using a sterile 0.45 micron filter. 
U
Adults and the elderly
U 
0.1 - 0.2 ml/kg body weight. 
_U_
_Children _
Not recommended. 

CONTRA-INDICATIONS 
Methylthionium Chloride injection in contraindicated in the following circumstances: 
Glucose-6-phosphate dehydrogenase deficiency 
Sodium nitrite induced methaemaglobinaemia. 
Severe renal impairment, chlorate poisoning, cyanide poisoning 
Known hypersensitivity to the medicine 

Not to be administered by intra-spinal injection or subcutaneous injection 

WARNING AND PRECAUTIONS 

Methylthioninium Chloride must be injected very slowly over a period of several 
minutes to prevent high local concentrations of the compound from producing 
additional methaemoglobin. Do not exceed the recommended dosage.  
CNS TOXICITY 
The use of methylthioninium chloride for localization in parathyroid surgery is not an 
approved  indication  Adverse  CNS  effects  including  confusion,  disorientation, 
agita