Baclofen Sintetica

Baclofen Sintetica is a muscle relaxant injected directly into the spinal fluid to relieve severe muscle stiffness (spasticity) caused by conditions like brain or spinal cord injuries and multiple sclerosis.

Form
infuusioneste, liuos
Strength
0.5 mg/ml
Active Ingredient
Baclofen
Manufacturer
Sintetica GmbH

How to Use

Dosage

Your doctor will decide your dose based on your condition and how you respond to the medicine. Treatment starts with a small dose, which is slowly increased over several days.

Method

This medicine is given as an injection directly into your spinal fluid (intrathecal injection) by a healthcare professional. For ongoing treatment, an implantable pump delivers the medicine continuously under your skin.

Important

Your doctor will set the maximum daily dose for you to ensure it's safe and effective, and will monitor you during treatment.

Possible Side Effects

COMMON
  • Tiredness, drowsiness, or weakness
  • Decreased muscle tone (muscular hypotonia)
  • Apathy (lack of energy)
  • Headache, dizziness, lightheadedness
  • Pain, fever, or chills
  • Seizures
  • Tingling in hands or feet
  • Vision problems
  • Slurred speech
  • Insomnia
  • Breathing difficulties, 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 excessive salivation
  • Rash and itching, swelling of face or hands and feet
  • Urination problems (incontinence or difficulty)
  • Muscle cramps
  • Sexual problems in men
  • Sedation (feeling calm or sleepy from medicine)
RARE
  • Unusual feeling of cold
  • Memory loss
  • Euphoric mood or hallucinations, suicidal thoughts
  • Difficulty swallowing, loss of taste, dehydration
  • Lack of muscle control or coordination problems (ataxia)
  • Increased blood pressure
  • Slow heart rate
  • Deep vein thrombosis (blood clot in leg)
  • Skin flushing or paleness, excessive sweating
  • Hair loss
  • Suicide attempts
  • Paranoia
  • Involuntary eye movements (nystagmus)
  • Bowel obstruction (ileus)
  • Potentially life-threatening withdrawal symptoms

Important Warnings

  • Do not use if you are allergic to baclofen or any other ingredients in this medicine.
  • Do not use if you have severe epilepsy that is hard to control.
  • Do not stop this treatment suddenly, as it can cause serious withdrawal symptoms. Always attend your pump refill appointments.
  • If you have thoughts of harming yourself or 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.
Show 1 more warnings
  • This medicine can make you sleepy or dizzy, or cause vision problems. Do not drive or operate machinery if you experience these symptoms.

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)