Baclofen Sintetica
This medicine helps relax very stiff muscles (spasticity) by being injected directly into the fluid around your spinal cord.
Form
injektioneste, liuos
Strength
0.05 mg/ml
Active Ingredient
Baclofen
Manufacturer
Sintetica GmbH
How to Use
Dosage
Your doctor will determine the right dose for you by testing your response, starting with a small amount and gradually increasing it over several days.
Method
The medicine is given as an injection directly into the fluid around your spinal cord (intrathecal injection) by a healthcare professional.
Important
The maximum daily dose is adjusted by your doctor over several days to find what works best for you, based on your response.
Possible Side Effects
COMMON
- •Feeling tired, sleepy, or weak
- •Decreased muscle tension (flabby muscles)
- •Lack of energy (apathy)
- •Headache, dizziness, or lightheadedness
- •Pain, fever, or chills
- •Seizures (fits)
- •Tingling or numbness in hands or feet
- •Vision problems
- •Slurred speech
- •Trouble sleeping (insomnia)
- •Difficulty breathing, pneumonia
- •Confusion, anxiety, agitation, or depression
- •Low blood pressure (fainting)
- •Nausea or vomiting, constipation, and diarrhea
- •Loss of appetite or reduced appetite, dry mouth, or too much saliva
- •Rash and itching, swelling of face, hands, or feet
- •Urinary incontinence or problems with urination
- •Sexual problems in men
- •Feeling very calm or sleepy (sedation)
RARE
- •Feeling unusually cold
- •Memory loss
- •Feeling euphoric (very happy) and hallucinations, thoughts of suicide
- •Difficulty swallowing, loss of taste, dehydration
- •Poor muscle control or difficulty coordinating voluntary movements (ataxia)
- •High blood pressure
- •Slow heart rate
- •Deep vein thrombosis (blood clot in the leg)
- •Flushing or pale skin, excessive sweating
- •Hair loss
- •Paranoia (feeling suspicious of others)
- •Involuntary, rapid eye movements (nystagmus)
- •Bowel obstruction (ileus)
- •Potentially life-threatening withdrawal symptoms
- •Restlessness or general discomfort (dysphoria)
- •Abnormally slow breathing
- •Increased sideways curvature of the spine (scoliosis)
- •Impotence
- •Allergic reaction (hypersensitivity)
Important Warnings
- Do not use if you are allergic to baclofen or any other ingredient in this medicine.
- Do not use if you have severe epilepsy that is hard to control.
- Do not use by any other way than direct injection into the spinal fluid.
- Tell your doctor if you are receiving other injections into your spine.
- Tell your doctor if you have an infection.
Show 20 more warnings
- Tell your doctor if you have had a head injury in the last year.
- Tell your doctor if you have had a crisis caused by autonomic dysreflexia (a serious reaction of the nervous system causing very high blood pressure).
- Tell your doctor if you have had a stroke.
- Tell your doctor if you have stomach ulcers or other digestive problems.
- Tell your doctor if you have a mental illness.
- Tell your doctor if you are being treated for high blood pressure.
- Tell your doctor if you have Parkinson's disease.
- Tell your doctor if you have liver, kidney, heart, or breathing problems.
- Tell your doctor if you have diabetes.
- Tell your doctor if you have trouble urinating.
- If you are going to have surgery, make sure your doctor knows you are receiving Baclofen Sintetica treatment.
- Using a PEG tube increases the risk of infections in children.
- If the fluid flow around your brain and spinal cord is blocked due to inflammation or injury, tell your doctor.
- Contact your doctor immediately if you think Baclofen Sintetica is not working as usual. It is important to make sure the pump is working correctly.
- Do not stop Baclofen Sintetica treatment suddenly, as there is a risk of withdrawal symptoms. Make sure you attend all hospital appointments for pump refills.
- Tell your doctor immediately if you experience back, shoulder, neck, or buttock pain during treatment (a spinal deformity called scoliosis).
- If you have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately.
- Avoid alcohol during treatment, as it can make the medicine's effects stronger or unpredictable.
- If you are pregnant, breastfeeding, planning to get pregnant, or think you might be pregnant, ask your doctor or pharmacist for advice before using this medicine.
- This medicine can make you sleepy, dizzy, or cause eye problems. Do not drive or operate machinery until these symptoms have stopped.
Use in Elderly Patients
Category D
Avoid use in older adults. Reduce the dose already in mild renal impairment. Significant adverse effects include sedation, confusion, depression, nightmares, muscular weakness and hypotension. Increases risk of falls. (updated 16.9.2024)