Patient Medication Information: uses, side effects, how to take - Dantrium Capsules (Par Pharmaceutical Companies)
ABOUT THIS MEDICATION
What the medication is used for:
Relief of chronic spasticity (spasms and stiffness) of
skeletal muscle in conditions such as spinal cord injury, cerebral palsy, multiple sclerosis and stroke.
Pre-operative management of surgical patients who
are susceptible to malignant hyperthermia (MH; a genetic muscle condition where sustained muscle contractions and/or life-threatening reactions may occur when susceptible individuals are exposed to specific anaesthetic drugs. In very rare cases, MH reactions may occur without anaesthetic).
Follow-up management of patients treated with
intravenous dantrolene.
What it does:
Dantrium reduces excessive muscle contractions.
When it should not be used:
Dantrium is not suitable for everyone. It should not be used:
If you are allergic to Dantrium (dantrolene sodium)
or any of its ingredients (See What the important nonmedicinal ingredients are)
If muscle tension is needed to maintain function
(e.g., sustaining upright posture and balance)
If you have reduced lung capacity (e.g., obstructive
pulmonary disease)
If you have active liver disease (e.g., hepatitis,
cirrhosis)
Use of Dantrium to relieve muscle spasms from rheumatic disorders is not recommended.
What the medicinal ingredient is:
Dantrolene Sodium
What the important nonmedicinal ingredients are:
edible black ink, gelatin, iron oxide red, iron oxide yellow, lactose, magnesium stearate, starch, talc, titanium dioxide.
What dosage forms it comes in:
- Dantrium 25 mg is an orange and tan-brown capsule coded with 1 black bar and DANTRIUM 25 mg 0149 0030.
- Dantrium 100 mg is an orange and tan-brown capsule coded with 3 black bars and DANTRIUM 100 mg 0149 0033.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- Dantrium has a potential for serious liver disease, sometimes fatal. For symptoms of liver disease see Side Effects And What To Do About Them.
- Populations that may be at greater risk include women, patients over the age of thirty, patients taking other medication(s) or taking other therapies that have the potential to cause liver damage.
Dantrium has been shown to cause cancer in rats.
Thus a potential for Dantrium to cause cancer in humans can not be ruled out. Discuss with your doctor.
BEFORE you use Dantrium talk to your doctor or pharmacist if:
- You have liver disease
- You have heart disease
- You have lung disease
- You are using rehabilitation devices such as wheelchair, crutches, braces, walkers or canes
- You are allergic to drugs that are chemically related to Dantrium
You are pregnant or you may become pregnant
- You are nursing
- The patient is a child under 5 years of age. Dantrium is usually not recommended in this age group.
If you are taking this medication for a long period of time, you will need to go for regular testing of your blood, liver and kidneys.
This medicine may make your skin more sensitive to sunlight. It is important to use a sunscreen when outdoors and avoid the use of sunlamps.
You should not drive, operate machinery or engage in activities that require unimpaired judgement and coordination during the first week of therapy.
INTERACTIONS WITH THIS MEDICATION
If taken with some other medicines, the effects of Dantrium or the effects of other medicines may be affected. Please check with your doctor or pharmacist before taking other medications with Dantrium.
Drugs that may interact with Dantrium include alcohol, some muscle relaxants, tranquilizing agents, antihistamines, sedatives, tranquilizers, pain medication, seizure medication, calcium channel blockers or anaesthetics.
It is important to tell your doctor what other medications you are taking, even if the medicine does not require a prescription (including vitamins and herbal supplements).
PROPER USE OF THIS MEDICATION
Usual dose:
The dosage of Dantrium will be tailored to meet the needs of each patient.
Adults: The initial dose is 25 mg once per day and may be increased, as needed and tolerated, to a maximum of 100 mg four times a day.
Children: The dose is determined using body weight. The usual starting dose is 0.5 mg/kg of body weight twice a day and may be increased as needed and tolerated to a maximum of 3 mg/kg four times daily.
This medicine has been prescribed to you by your doctor. Do not share this medication with anyone else.
Follow the doctor’s instruction about how and when you should take your medication. Your doctor may adjust your dose to get the best effect. Speak with your doctor if you are concerned about the dose.
If you are taking care of a child who has been prescribed Dantrium, follow the doctor’s instructions carefully.
Overdose:
If you take more than the recommended number of capsules, immediately contact your doctor or pharmacist or go to the nearest emergency department.
Missed Dose:
If you miss a dose, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. DO NOT take two doses at once to make up for a missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with any medication, side effects may occur with Dantrium use. The most common side effects include diarrhoea, drowsiness, weakness, dizziness, feeling ill and fatigue.
Other commonly reported side effects include loss of appetite, abdominal pain, nausea, vomiting, skin rash, fever and chills, headache.
Rarely reported side effects include constipation, difficulty swallowing, sweating, increased urinary frequency.
IMPORTANT SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
Only if severe | In all cases | ||||
| Common (more than 1 in 100) | |||||
Symptoms of liver problems including: pale stools, yellow skin or eyes, itching and rash, loss of appetite, nausea and vomiting | √ | ||||
Chest pain, palpitations/fluttering of the heart, difficulty breathing | √ | ||||
| Seizure, speech and visual disturbance | √ | ||||
| Uncommon (less than 1 in 100) | |||||
| Mental depression or confusion | √ | ||||
| Worsening of heart failure | √ | ||||
This is not a complete list of side effects. For any other side effects or health concerns while taking Dantrium, contact your doctor or pharmacist.
HOW TO STORE IT
Dantrium should be stored at room temperature (15 - 30° C).
The expiry date of this medication is printed on the label. Do not use the medication after this date.
This medicine is for you or the child you are taking care of. Only a doctor can prescribe it for you or your child.
Never give it to others. It may harm them.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals is available by contacting the distributor, Methapharm Inc. at:
1-800-287-7686