Patient Medication Information: uses, side effects, how to take - Dantrolene Sodium for Injection, USP
What is DANTROLENE SODIUM FOR INJECTION, USP used for?
DANTROLENE SODIUM FOR INJECTION, USP 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 DANTROLENE SODIUM FOR INJECTION, USP work?
DANTROLENE SODIUM FOR INJECTION, USP belongs to a group of medicines called skeletal muscle relaxants. It helps to reduce excessive muscle contractions.
What are the ingredients in DANTROLENE SODIUM FOR INJECTION, USP?
Medicinal ingredient: dantrolene sodium.
Non-medicinal ingredients: mannitol and sodium hydroxide.
DANTROLENE SODIUM FOR INJECTION, USP comes in the following dosage forms:
Powder for solution: 20 mg / vial of dantrolene sodium.
Do not use DANTROLENE SODIUM FOR INJECTION, USP if:
- you are allergic to dantrolene sodium or any of the other ingredients in DANTROLENE SODIUM FOR INJECTION, USP.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DANTROLENE SODIUM FOR INJECTION, USP. 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 DANTROLENE SODIUM FOR INJECTION, USP, can induce a decrease in the grip strength and weakness of leg muscles, especially walking down stairs. 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 DANTROLENE SODIUM FOR INJECTION, USP, can cross the placenta. It is not known if it can harm an unborn baby. DANTROLENE SODIUM FOR INJECTION, USP 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 DANTROLENE SODIUM FOR INJECTION, USP, 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: DANTROLENE SODIUM FOR INJECTION, USP 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 DANTROLENE SODIUM FOR INJECTION, USP:
- 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 DANTROLENE SODIUM FOR INJECTION, USP:
- Your healthcare professional will prepare and give you or child DANTROLENE SODIUM FOR INJECTION, USP in a hospital or medical setting.
- You or your child will receive DANTROLENE SODIUM FOR INJECTION, USP 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 child’s current health, weight, if other medicines are taken, and the reaction to DANTROLENE SODIUM FOR INJECTION, USP.
Overdose:
Signs of an overdose with DANTROLENE SODIUM FOR INJECTION, USP may include:
- muscle weakness,
- drowsiness,
- altered state of consciousness (e.g., lack of energy or coma),
- vomiting
- diarrhea
- crystals in urine (crystalluria).
What are possible side effects from using DANTROLENE SODIUM FOR INJECTION, USP?
These are not all the possible side effects you may have when taking DANTROLENE SODIUM FOR INJECTION, USP. 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
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| 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, | ||
| √ | ||
If you think you, or a person you are caring for, have taken too much DANTROLENE SODIUM FOR INJECTION, USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669)immediately, even if there are no signs or symptoms.
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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.
Storage:
- Your healthcare professional will store DANTROLENE SODIUM FOR INJECTION, USP for you. The unreconstituted vials of DANTROLENE SODIUM FOR INJECTION, USP will be stored between 15°C to 30°C and the reconstituted solution will be stored between 15°C to 30°C, protected from light.
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.
- Keep out of reach and sight of children.
If you want more information about DANTROLENE SODIUM FOR INJECTION, USP:
- Talk to your healthcare professional;
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.hikma.com/, or by calling 1-888-656-0793.