The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20011/0034.
Dantrium IV 20mg
Dantrium® IV 20 mg
Powder for Solution for Injection
1. What Dantrium IV is and what it is used for
2. What you need to know before you are given Dantrium IV
3. How Dantrium IV is given
4. Possible side effects
5. How to store Dantrium IV
6. Contents of the pack and other information
Dantrium IV belongs to the pharmacotherapeutic group of direct-acting muscle relaxants. It is used for the treatment of malignant hyperthermia. The ATC code is M03CA01.
Dantrium IV is a medicine which will be administered to you by a doctor or nurse.
If you are allergic (hypersensitive) to dantrolene sodium or any of the other ingredients of Dantrium IV (see section 6).
Take special care with Dantrium IV. You will probably have been given Dantrium IV before you read this leaflet. The urgent need for treatment will have been more important than anything else at the time. Before you are given this injection, your doctor will try to find out if you have had a serious reaction to dantrolene sodium or any of the other ingredients of Dantrium IV in the past.
Tell your doctor if you are taking, or have recently taken, or might use any other medicine.
The following medicines affect the way Dantrium IV works:
Tell your doctor if you are pregnant or breastfeeding. Dantrium IV should not be given unless considered essential.
For a period of up to 48 hours after you have been given Dantrium IV, your hand and leg muscles may be weak and you may also have a feeling of “light headedness”. If you are affected in this way, do not drive or operate machinery during this time.
This medicine contains less than 1mmol sodium (23mg) per vial that is to say essentially “sodium free”.
This injection is given to you by a doctor, into a vein. The dose of Dantrium IV is based on body weight; in most cases, a total dose of up to 10mg may be given for each kilogram of your body weight. However, a total dose of up to 40mg for each kilogram of your body weight may be required in rare cases
Malignant hyperthermia is an emergency situation where rapid infusion of a high Dantrium IV dose is necessary. There are no known specific symptoms of dantrolene sodium overdose. Caution is required if there are any signs of hyperkalaemia.
If it should appear necessary to discontinue Dantrium IV therapy, intensive care and supportive therapeutic measures which have been initiated should be continued on an individual basis.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects were observed:
Unknown (Frequency cannot be estimated from the available data):
muscle weakness, tiredness, dizziness, headache, gastrointestinal complaints such as nausea, vomiting, diarrhoea, anaphylaxis, allergic reactions, mostly of the skin, as well as thrombophlebitis or reactions at the application site, somnolence, convulsion, speech disorder, bradycardia (slowed heartbeat), tachycardia (accelerated heartbeat), pleural effusion (fluid collection in the chest), respiratory failure, abdominal pain, gastrointestinal bleeding, jaundice, hepatitis, hyperhidrosis (increased sweat secretion), crystalluria (accumulation of crystals in urine sediment), heart failure.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children. Do not store Dantrium IV above 25°C.
The solution for injection should be stored between 15 and 25°C, not be refrigerated or frozen, protected from direct light and used within 6 hours of being made up.
Do not use Dantrium IV after the expiry “EXP” date which is stated on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The product is a pale orange-yellow powder for solution for injection, supplied to hospitals in packs of 12 and 36 glass vials. Not all pack sizes may be marketed. Each vial is provided with a single use filtration device.
If you need the information on this leaflet in an alternative format such as large print, please ring from the UK 0800 198 5000.
This leaflet was last revised in April 2022.