Gablofen 40,000 mcg/20 mL (2,000 mcg/mL) intrathecal syringe

Generic name:
Baclofen - injection

Pronunciation
(BAK-loe-fen)

Brand name(s)
Lioresal

Do not stop using this medication without consulting your doctor. Serious (rarely fatal) withdrawal problems may occur if this medication is suddenly stopped. Get medical help right away if you have any signs of a withdrawal reaction, including: itching, numb/tingling skin, high fever, mental/mood changes (such as confusion), seizures, worsening muscle tightness/stiffness, signs of kidney problems (such as change in the amount of urine). Tell your doctor if you ever had a withdrawal reaction from baclofen.

Keep all appointments for refilling the pump to avoid any serious withdrawal problems. Your doctor or another health care professional will check that the pump is programmed and working properly during these appointments. If you must miss a refill appointment, contact your doctor right away to reschedule the appointment before you run out of medication. Also, learn what your pump alarm sounds like. If you hear the alarm, contact your doctor right away.

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles.

Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.

This medication is given by injection into the area around the spinal cord (intrathecal). It is usually given using a drug pump implanted under your skin. A health care professional will fill and refill the pump with medication.

The dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Do not stop treatment with this drug without consulting your doctor. If you suddenly stop using this medication, you may have serious withdrawal symptoms. See also Warning section. To prevent withdrawal, your doctor may lower your dose slowly. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not get better or if it gets worse, or if you have any signs of infection (such as fever, chills, redness/swelling/pain/warmth at the pump site).

Drowsiness, dizziness, weakness, headache, constipation, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, depression, hallucinations)
• numb/tingling skin
• vision changes
• difficulty urinating

Get medical help right away if you have any very serious side effects, including:

• seizures
• trouble breathing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• recent/current infection
• seizures
• mental/mood disorders (such as schizophrenia)
• kidney disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, seizures, severe muscle weakness, loss of consciousness.

Keep all medical and lab appointments.

Keep all of your appointments to refill the medication. If you plan to travel, talk with your doctor ahead of time about your refill schedule so you do not run out of medication while you are away from home.

This drug is to be given continuously as an infusion. If your infusion is interrupted, contact your doctor or pharmacist right away. If you miss an appointment to refill the medication, contact your doctor right away to reschedule before the pump runs out of drug.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.