Details for: LIORESAL INTRATHECAL
Company: NOVARTIS PHARMACEUTICALS CANADA INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02131048 | LIORESAL INTRATHECAL 0.05MG/ML | BACLOFEN | 0.05 MG / ML | SOLUTION | INTRATHECAL |
02131056 | LIORESAL INTRATHECAL 0.5MG/ML | BACLOFEN | 0.5 MG / ML | SOLUTION | INTRATHECAL |
02131064 | LIORESAL INTRATHECAL 2MG/ML | BACLOFEN | 2 MG / ML | SOLUTION | INTRATHECAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
LIORESAL Intrathecal belongs to a group of medicines called muscle relaxants. It is used to reduce and relieve the excessive stiffness and/or spasms occurring in various illnesses such as, for example, multiple sclerosis, diseases or injuries of the spinal cord, and certain brain disorders.
What it does
The solution is injected or infused into the fluid space
around the spinal cord by use of a special pump
which is implanted under the skin of your abdomen.
From the pump a constant amount of the solution is
delivered into the fluid space around the spinal cord
through a tiny tube.
Due to the beneficial effect on muscle contractions
and the consequent relief from pain, LIORESAL
Intrathecal improves your mobility and your ability to
manage your daily activities without aid.
LIORESAL also helps you to benefit more from
physiotherapy.
When it should not be used
You should not be treated with LIORESAL IT if you:
are allergic (hypersensitivity) to LIORESAL
Intrathecal or any of the other ingredients of
LIORESAL Intrathecal listed below.
What the medicinal ingredient is
baclofen
What the non-medicinal ingredients are
LIORESAL IT contains: sodium chloride and water for injection
What dosage form it comes in
LIORESAL Intrathecal (baclofen injection) 0.05
mg/mL: Each 1 mL ampoule contains 0.05 mg
baclofen for intrathecal administration.
LIORESAL Intrathecal (baclofen injection) 0.5
mg/mL: Each 20 mL ampoule contains 10 mg
baclofen for intrathecal administration.
LIORESAL Intrathecal (baclofen injection) 2
mg/mL: Each 5 mL ampoule contains 10 mg
baclofen for intrathecal administration.
Warnings and precautions
LIORESAL Intrathecal is suitable for many, but not
all, patients with muscle spasms.
BEFORE you use LIORESAL IT talk to your
doctor or pharmacist if you:
If any of these apply to you, your doctor may not want to give you this medicine or may want to take special precautions. If you have not told your doctor about any of these things, tell him/her before you start LIORESAL Intrathecal treatment.
If you think you may be allergic, ask your doctor for advice.
Get urgent medical help if you observe that your implanted device is not working and you also notice withdrawal symptoms (see Missed dose).
Tell your doctor immediately if you get any of these symptoms during treatment with LIORESAL Intrathecal:
Driving and using machines: LIORESAL Intrathecal may make you feel sleepy or dizzy. Be careful when driving a car or using a machine or doing things that need careful attention until you are feeling normal again.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
herbal and non- prescription medicines (over the
counter). Some other medicines may interact with
LIORESALIT. Your doctor may change the dosage
or sometimes stop one of the medicines. This is
particularly important for the following medicines:
Always tell your doctor or nurse about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Be careful if you drink alcoholic beverages during treatment with LIORESAL Intrathecal as you may feel more sleepy or dizzy than usual.
Proper use of this medication
Usual dose:
LIORESAL Intrathecal can only be given by
experienced doctors using special medical
equipment. You will need to stay in hospital, at least
at the beginning of treatment.
Your doctor will inject a small amount of
LIORESAL Intrathecal into your spinal cord to see if
it improves your muscle spasms. If it does, then a
special pump will be implanted under your skin. The
pump will give you a small amount of medicine all
the time.
It may take several days to find out the amount of
medicine that suits you best, your doctor will keep a
close watch on you during this time.
After that, your doctor will still want to see you
regularly to check your progress and make sure your
pump is working well.
IT IS OF UTMOST IMPORTANCE THAT
APPOINTMENTS TO REFILL THE PUMP ARE
KEPT, OTHERWISE SPASMS MAY RECUR
BECAUSE YOU ARE NOT GETTING A HIGH
ENOUGH DOSE OF LIORESAL INTRATHECAL.
MUSCLE SPASTICITY MAY NOT IMPROVE OR
MAY WORSEN AS A RESULT.
If muscle spasticity is not improving or if you start
having spasms again, either gradually or suddenly,
contact your doctor immediately.
Please consult the pump manufacturer's literature for
information regarding proper home care of the pump
and the insertion site.
Monitoring during treatment with LIORESAL
Intrathecal
You will be monitored closely in a fully equipped
and staffed environment during the screening phase
and dose-titration period immediately following
pump implant. You will regularly be assessed for
your dosage requirements, for possible side effects or
evidence of infection. The functioning of the delivery
system will also be checked.
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, or
planning to become pregnant as LIORESAL
Intrathecal should not be used during pregnancy, or if
you are breast-feeding. Ask your doctor or
pharmacist for advice before taking any medicine.
Your doctor will discuss with you the potential risk
of taking LIORESAL Intrathecal during pregnancy.
Use of LIORESAL Intrathecal during pregnancy
may result in the newborn experiencing withdrawal
from the drug including, irritability, high-pitched
crying, trembling, increased muscle tone, excessive
sucking, disordered sleep, increase in body
temperature, uneven discolored patches on the skin,
and convulsions and other symptoms related to
sudden stop of treatment sometime after delivery.
Your doctor may need to treat your newborn for
withdrawal reactions. The doctor will decide if you
may receive LIORESAL Intrathecal in these special
situations. Only very small quantities of LIORESAL
pass into the breast milk. Ask your doctor if you want
to breast-feed.
Overdose:
Signs of overdose may appear suddenly or insidiously e.g. by a malfunctioning of the pump. It is very important that you and those caring for you recognize signs of overdosage. If you experience any one or a combination of the following symptoms, tell your doctor without delay as the amount of drug you receive may be too high:
Missed Dose:
Abruptly stopping LIORESAL Intrathecal can result in serious medical problems and in rare cases has been fatal.
Signs that your pump is not functioning properly or that it is not delivering the right amount of medication include an increase or return in spasticity, itching, low blood pressure, lightheadedness, tingling sensation, high fever, altered mental status, muscle rigidity or new muscle weakness or paralysis, persistent erection of the penis (priapism) and infection (sepsis). It is important to tell your doctor immediately if you experience any of the above symptoms. These signs may be followed by more serious side effects (including death) unless you are treated immediately.
Side effects and what to do about them
As with all medicines, patients treated with
LIORESAL Intrathecal, may experience some side
effects, although not everybody gets them. These
occur more often at the start of treatment during your
hospital stay but they may also occur later and should
be checked with your doctor.
Very common: Drowsiness, muscle weakness
Common: Feeling of anxiety, sedation and weariness
(exhaustion), weakness in the legs, stiffness in the
muscles, dizziness/light-headedness, headache,
sleepiness, feeling sick and/or vomiting, tingling in
the hands and feet, insomnia, slurred speech,
pneumonia, weakness, chills, fatigue, pain, dry
mouth, skin rash and/or itching, swelling of the
ankles, feet, or lower legs, puffy face, unusual
nervousness or restlessness, confusion/disorientation,
constipation, diarrhea, decreased appetite, excessive
salivation, fever/shivering, urinary problems, sexual
difficulties.
Uncommon: Mood or mental changes, paranoia,
feeling extreme happiness (euphoria), loss of muscle
coordination (ataxia), abnormally low body
temperature, memory loss, continuous uncontrollable
eye movements, decreased sense of taste, difficulty in
swallowing, abdominal pain, hair loss, excessive
sweating.
Unknown frequency: restlessness (dysphoria),
abnormally slow breathing rate (bradypnea), increase in sideways curvature of the spine (scoliosis),
inability to achieve or maintain an erection (erectile
dysfunction).
Tell your doctor if you notice any other effect.
Some side effects could be associated with the
delivery system
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and immediately seek assistance |
---|---|---|---|
Common | |||
Low Blood Pressure: dizziness, fainting, lightheaded ness | ✔ | ||
Trouble breathing: Shortness of breath or unusually slow or troubled breathing | ✔ | ||
Uncommon | |||
Unusually slow heartbeat | ✔ | ||
Depression : Feeling sad, loss of interest in usual activities, hopelessnes s, insomnia or sleeping too much | ✔ | ||
Suicidal Behavior: thoughts or actions about hurting or killing yourself | ✔ | ||
Hallucinations: seeing or hearing things that are not real | ✔ | ||
Trouble with vision: blurred vision, double vision | ✔ | ||
Unknown | |||
Implanted drug delivery device or infusion system malfunction can lead to withdrawal symptoms including death | ✔ |
How to store
Store LIORESAL IT ampoules between 15-30°C
(protect from heat). Do not freeze. Do not heat
sterilize.
Keep all medicines out of the reach and sight of
children.
This medicine is prescribed for your specific
medical problem and for your own use only. Do
not give to other people.
Do not use outdated medicines. Discard them safely
out of the reach of children or take them to your
pharmacist who will dispose of them for you.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) 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.
More information
This document plus the full product monograph,
prepared for health professionals can be found at:
www.novartis.ca
or by contacting the sponsor, Novartis
Pharmaceuticals Canada Inc, at: 1-800-363-8883
This leaflet was prepared by:
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Last Revised: May 5, 2020
LIORESAL is a registered trademark.