Patient Medication Information: uses, side effects, how to take - Dantrium Capsules (Knight Therapeutics)
Serious Warnings and Precautions
Liver problems:
See the Serious side effects and what to do about them table for more information on this and other serious side effects. Cancer: DANTRIUM CAPSULES may increase your risk of cancer. Your healthcare professional will assess your risk and decide if the expected benefits of taking DANTRIUM CAPSULES outweigh the possible risks to your health. |
What is DANTRIUM CAPSULES used for?
DANTRIUM CAPSULES is used in adults and children (5 to 18 years of age):
- to relieve chronic muscle stiffness and cramping (spasms) caused by certain medical problems such as cerebral palsy, multiple sclerosis, stroke, and injuries to the spine.
- before surgery or anesthesia to prevent a medical problem called malignant hyperthermia (MH) in patients at risk. MH is a severe reaction that may occur when susceptible individuals are exposed to certain anesthetic medicines. It can be life-threatening. MH may involve severe muscle contractions, a dangerously high body temperature, a rapid heartbeat, and other symptoms. Your risk of MH increases if you have certain gene mutations.
- as follow-up management after being treated with intravenous dantrolene sodium.
How does DANTRIUM CAPSULES work?
DANTRIUM CAPSULES belongs to a group of medicines called skeletal muscle relaxants. It reduces excessive muscle contractions.
What are the ingredients in DANTRIUM CAPSULES?
Medicinal ingredient: dantrolene sodium
Non-medicinal ingredients: edible black ink, FD&C yellow 6, gelatin, iron oxide red, iron oxide yellow, lactose, magnesium stearate, sodium lauryl sulfate, starch, talc, and titanium dioxide
DANTRIUM CAPSULES comes in the following dosage forms:
Capsules: 25 mg
Do not use DANTRIUM CAPSULES if:
- you are allergic to dantrolene sodium or any other ingredients in DANTRIUM CAPSULES.
- muscle tension allows you to keep an upright posture, to balance during movement, or help you carry out your daily activities.
- you have reduced lung capacity particularly due to an obstructive pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), emphysema, asthma, chronic bronchitis or cystic fibrosis).
- you have active liver problems (e.g., hepatitis, cirrhosis).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DANTRIUM CAPSULES. Talk about any health conditions or problems you may have, including if you:
- have heart problems
- have lung problems
- have a history of liver problems
- are allergic to other medicines of the hydantoin family, including phenytoin, fosphenytoin, nitrofurantoin, or nilutamide
- have an allergy to lactose • have a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- use rehabilitation devices such as wheelchair, crutches, braces, walkers or canes
- are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed
Other warnings you should know about:
Photosensitivity: You may become sensitive to the sun while taking DANTRIUM CAPSULES. You should reduce your exposure to sunlight until you know how you respond. Tell your healthcare professional if you notice any photosensitivity.
Muscle weakness: You may feel very weak while taking DANTRIUM CAPSULES. This usually lasts only for a short time. Tell your healthcare professional if your muscle weakness persists or interferes with the use of rehabilitation devices such as wheelchairs, crutches, braces, walkers, or canes.
Pregnancy: Dantrolene sodium, the active ingredient in DANTRIUM CAPSULES, can cross the placenta. It is not known if it can harm an unborn baby. DANTRIUM CAPSULES 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. Tell your healthcare professional right away if you become pregnant or think you might be pregnant during your treatment with DANTRIUM CAPSULES.
Breastfeeding: Dantrolene sodium, the active ingredient in DANTRIUM CAPSULES, can pass into breast milk. It is not known if it can harm a breastfed baby. Do not breastfeed while taking DANTRIUM CAPSULES. Talk to your healthcare professional about the best way to feed your baby during this time.
Driving and using machines: DANTRIUM CAPSULES can cause dizziness, 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 during the first week of your treatment with DANTRIUM CAPSULES.
Check-ups and testing: You will 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 CAPSULES:
- other muscle relaxants
- anesthetics (used during surgery and other procedures)
- sedatives and tranquilizers (used to treat anxiety, panic and sleep disorders)
- seizure medications (used to prevent and treat seizures)
- pain medications
- antihistamines (used to treat allergies)
- calcium channel blockers (used to lower blood pressure and relieve chest pain)
- alcohol
- estrogen therapies (used for birth control, hormone replacement)
- metoclopramide (used to treat symptoms of slowed stomach emptying seen in patients with gastritis and in those recovering from gastric tests or surgery)
How to take DANTRIUM CAPSULES:
- Before taking DANTRIUM CAPSULES, you and your healthcare professional will decide on a goal you would like to reach during your treatment. This may include regaining or keeping a certain function. This includes an exercise program, the use of braces, certain movements or physical abilities, etc.
- During your treatment with DANTRIUM CAPSULES, your healthcare professional may gradually increase your dose. They will give you the lowest possible dose needed to reach the best outcome.
- Take DANTRIUM CAPSULES exactly as your healthcare professional has told you. If you are taking care of a child for whom DANTRIUM CAPSULES have been prescribed, follow the healthcare professional’s instructions carefully.
- Your treatment may be discontinued if no benefit is seen within the first 45 days. This is to prevent potential liver damage associated with long-term use of DANTRIUM CAPSULES.
- This medicine has been prescribed for you by your healthcare professional. Do not share this medicine with anyone else.
Usual dose:
Your healthcare professional will decide on the dose that is right for you or your child.
For use in chronic muscle stiffness and cramping
- Adults: The initial dose is 25 mg once a day. Your dose may be increased as needed and tolerated to a maximum of 100 mg four time a day.
Children (5 to 18 years of age): Your child’s dose will be determined using their body weight. The usual starting dose is 0.5 mg per each kilogram they weight twice a day. Their dose may be increased as needed and tolerated to a maximum of 3 mg for each kilogram they weight four times a day.
For malignant hyperthermia (MH)
Before surgery:
- For 1 or 2 days before surgery, you will take 4 to 8 mg/kg per day.
- This will be given to you in 3 or 4 divided doses.
- The last dose will be around 3 to 4 hours before the surgery.
After the surgery:
- After a MH crisis, for 1 to 3 days period, you will take 4 to 8 mg/kg per day to stop MH from happening again.
- This will be divided into 4 doses.
Overdose:
Signs of an overdose with DANTRIUM CAPSULES may include:
- muscle weakness
- altered state of consciousness (e.g., lack of energy or coma)
- vomiting
- diarrhea
| If you think you, or a person you are caring for, have taken too much DANTRIUM CAPSULES, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you have forgotten or missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not double the doses.
What are possible side effects from using DANTRIUM CAPSULES?
These are not all the possible side effects you may have when taking DANTRIUM CAPSULES. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- feeling drowsy, weak, dizzy, nervous, ill or fatigued
- diarrhea, constipation, abdominal cramps or pain
- nausea, vomiting
- difficulty swallowing
- headache
- fever, chills
- a heart rate that is faster than normal
- back pain, muscle aches and pain
- difficulty falling or staying asleep
- skin problems such as itchy skin, hives, acne- or eczema-like rashes
- difficulty getting or keeping an erection
- abnormal hair growth
- sweating
- problems with vision
- teary eyes
- changes in speech such as slurring
- changes in tastes
- confusion (feeling disoriented and/or distracted)
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 | |||||
| COMMON | ||||||
| Liver problems: jaundice (yellowing of the skin or whites of eyes), unusual dark urine, light-colored stool, loss of appetite, nausea, vomiting, abdomen pain or swelling, unusual tiredness, mental disorientation or confusion, sleepiness, coma | √ | |||||
| Pleural effusion (fluid around the lungs): chest pain that may get worse when you breathe, cough, sneeze or lie flat, shortness of breath that may get worse if you lie flat, cough, fever. May be accompanied with an abnormal heartbeat, general feeling of weakness or being sick, abdominal or leg swelling, skin rash or itchy skin | √ | |||||
| Seizures (fit): loss of consciousness with uncontrollable shaking | √ | |||||
UNCOMMON
Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or
hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of
√
| Respiratory depression (also known as hypoventilation): slow, shallow or weak breathing, blue lips, fingers, toes, confusion, headaches | √ | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||
| depression, your depression may become worse | ||||||||||
Worsening of heart failure: shortness of breath, feeling weak or tired, rapid weight gain, unusual swelling of the legs, feet, hands or abdomen, cough, reduced ability to do activities or exercises | √ | |||||||||
| UNKNOWN FREQUENCY | ||||||||||
| Changes in blood pressure: dizziness, headache, vision problems, shortness of breath, nausea, vomiting, fainting | √ | |||||||||
| Gastrointestinal bleeding in the stomach or bowels: black, tarry stool, blood in the stool | √ | |||||||||
| Intestinal obstruction (blockage that stops or impairs passage of contents of intestines): cramping pain in abdomen that may begin suddenly, bloating, loss of appetite, pain that comes and goes but will then last, nausea and vomiting, constipation or diarrhea | √ | |||||||||
| Phlebitis (swelling of a vein): pain, tenderness, redness or swelling | √ | |||||||||
| Urinary problems: inability to pass or empty the bladder, painful urination, lack of bladder control, frequent | √ | 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 | urination (including during the night) | ||
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:
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:
- Store DANTRIUM CAPSULES at room temperature (15°C to 30°C).
- Do not use the medication after the expiry date printed on the label.
- Keep out of reach and sight of children.
If you want more information about DANTRIUM CAPSULES:
- 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.