Patient Medication Information: uses, side effects, how to take - Dantrium Intravenous
What is DANTRIUM INTRAVENOUS used for?
DANTRIUM INTRAVENOUS is used in adults and children to manage malignant hyperthermia (MH).
MH is a severe reaction to certain anesthetic medicines and can be life-threatening. Symptoms include severe muscle contractions, dangerously high body temperature, and a rapid heartbeat, among others. You are at a higher risk of MH if you have certain gene mutations.
How does DANTRIUM INTRAVENOUS work?
DANTRIUM INTRAVENOUS belongs to a group of medicines called skeletal muscle relaxants. It helps to reduce excessive muscle contractions.
What are the ingredients in DANTRIUM INTRAVENOUS?
Medicinal ingredient: dantrolene sodium.
Non-medicinal ingredients: mannitol and sodium hydroxide.
DANTRIUM INTRAVENOUS comes in the following dosage forms:
Powder for solution: 20 mg / vial of dantrolene sodium.
Do not use DANTRIUM INTRAVENOUS if:
- you are allergic to dantrolene sodium or any of the other ingredients in DANTRIUM INTRAVENOUS.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DANTRIUM INTRAVENOUS. Talk about any health conditions or problems you may have, including if you:
- have a history of liver problems.
- are allergic to other medicines of the hydantoin family, including phenytoin, fosphenytoin, nitrofurantoin, or nilutamide.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Muscle weakness: Dantrolene sodium, the active ingredient in DANTRIUM INTRAVENOUS, can induce a decrease in the grip strength and weakness of leg muscles, especially walking downstairs. Caution is also indicated at meals on the day of administration because difficulty swallowing and choking have been reported.
Pregnancy: Dantrolene sodium, the active ingredient in DANTRIUM INTRAVENOUS, can cross the placenta. It is not known if it can harm an unborn baby. DANTRIUM INTRAVENOUS should not be taken during pregnancy unless your healthcare professional has determined the expected benefits outweigh the possible risks to your health and that of your baby.
Breastfeeding: Dantrolene sodium, the active ingredient in DANTRIUM INTRAVENOUS, can pass into breast milk. It is not known if it can harm a breastfed baby. Talk to your healthcare professional about the best way to feed your baby during this time.
Driving and using machines: DANTRIUM INTRAVENOUS can cause dizziness, lightheadedness, drowsiness, and weakness. Alcohol and medicines that affect the central nervous system (CNS) may increase this effect. You should not drive or do tasks that require special attention for 48 hours after administration.
Check-ups and testing: You may have regular visits with your healthcare professional, before and during your treatment. They may do tests to monitor the health of your kidneys and liver, and the profile of your blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DANTRIUM INTRAVENOUS:
- other muscle relaxants used to treat muscle spasms and back pain (such as vecuronium).
- tranquilizing agents used to treat anxiety, panic and sleep disorders.
- anesthetic agents used during surgery and other procedure.
- alcohol.
- calcium channel blockers used to lower blood pressure and relieve chest pain (such as verapamil).
- anticoagulant agents used to treat and prevent blood clots (such as warfarin).
- lipid-lowering agents used for controlling the high cholesterol and triacylglyceride level in the blood (such as clofibrate).
- medicines use to help reduce blood sugar level (such as tolbutamide).
- estrogen-containing therapies used for birth control and hormone replacement.
How to take DANTRIUM INTRAVENOUS:
- Your healthcare professional will prepare and give you or your child DANTRIUM INTRAVENOUS in a hospital or medical setting.
- You or your child will receive DANTRIUM INTRAVENOUS through your veins (i.e., “intravenously” or “IV”).
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Your healthcare professional will decide on the right dose for you or your child. This may depend on you or your child’s current health, weight, if other medicines are taken, and the reaction to DANTRIUM INTRAVENOUS.
Overdose:
Signs of an overdose with DANTRIUM INTRAVENOUS may include:
- muscle weakness,
- drowsiness,
- altered state of consciousness (e.g., lack of energy or coma),
- vomiting,
- diarrhea,
- crystals in urine (crystalluria).
If you think you, or a person you are caring for, have taken too much DANTRIUM INTRAVENOUS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using DANTRIUM INTRAVENOUS?
These are not all the possible side effects you may have when taking DANTRIUM INTRAVENOUS. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- choking,
- difficulty swallowing,
- loss of grip strength,
- muscle weakness,
- injection site reactions,
- redness of the skin,
- hives,
- lightheadedness.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| RARE | |||
| Pulmonary edema (excess fluid in the lungs): Coughing up blood or bloody froth, trouble breathing, shortness of breath, | √ | ||
| wheezing, noisy breathing, or quick, shallow breathing. | |||
| UNKNOWN FREQUENCY | |||
| Liver problems: Jaundice (yellowing of the skin or whites of eyes), unusual dark urine, light-colored stool, loss of appetite, nausea, vomiting, abdomen pain, abdomen swelling, unusual tiredness, mental disorientation, confusion, sleepiness, coma, or itchiness. | √ | ||
| Thrombophlebitis (inflamed or swollen vein from a blood clot): Swelling in the part of the body affected, pain in the part of the body affected, or skin redness, warmth and tenderness over the vein. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Your healthcare professional will store DANTRIUM INTRAVENOUS for you. The unreconstituted vials of DANTRIUM INTRAVENOUS will be stored between 20°C to 25°C and the reconstituted solution will be stored between 15°C to 30°C, protected from light.
- Keep out of reach and sight of children.
If you want more information about DANTRIUM INTRAVENOUS:
- Talk to your healthcare professional;
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com or by calling 1-844-483-5636.