Baclofen Solution for injection

What is this medicine?

BACLOFEN (BAK loe fen) is a muscle relaxer. It is used to treat severe spasms.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders
• diabetes
• mental illness
• kidney disease
• recent stroke
• seizures
• an unusual or allergic reaction to baclofen, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection into the space around the spinal cord. It can be given by a health care professional in a clinic or hospital setting. Patients can also have a pump implanted into their back for a continuous infusion.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important to keep your appointments to have this medicine administered or to refill your pump. If you cannot make your appointment, contact your health care provider to make other arrangements.

What may interact with this medicine?

• alcohol
• antihistamines
• medicines for depression, anxiety, and other mental conditions
• medicines for pain like codeine, oxycodone, tramadol, and propoxyphene
• medicines for sleep
• other medicines injected in the spine like morphine
• phenobarbital

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor if your symptoms do not get better or if you get worse.

Do not suddenly stop taking your medicine. If you do, you may develop a severe reaction. Contact your health care provider immediately if you notice any problems with your catheter (especially if it becomes disconnected), low volume in the pump, or low battery level. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects. Follow the advice of your doctor.

This medicine can affect blood sugar levels. If you have diabetes, talk with your doctor or health care professional before you take the medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• fast heartbeat
• feeling faint or lightheaded, falls
• hallucinations
• mood or mental changes
• problems with balance, talking, walking
• ringing or buzzing in the ears
• seizure
• trouble passing urine or change in the amount of urine
• unusually nervous, restless

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• confusion
• constipation or diarrhea
• dry mouth
• headache
• muscle weakness
• nausea, vomiting
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.