Kemstro

Baclofen is a prescription medication used to relieve spasms and increased muscle tone caused by multiple sclerosis or spinal injury. This medication belongs to a group of drugs called muscle relaxants. Although the way it works is not fully understood, baclofen may decrease the number and severity of muscle spasms by inhibiting nerve signals.

This medication comes in tablet form and are usually taken 3 or 4 times daily, with or without food.

This medication also comes as an injectable liquid to be given directly into the spinal fluid by a healthcare professional.

Common side effects include weakness, drowsiness, and dizziness. Do not drive or operate machinery until you know how this medication affects you.

​Oral/Injectable:

Baclofen is a prescription medication used to alleviate signs and symptoms of muscle spasms caused by multiple sclerosis or spinal cord injuries and other spinal cord diseases.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Schwarz Pharma Inc.

​Oral/Injectable:

Serious side effects have been reported. See "Baclofen Precautions" section.

Common side effects include:

• drowsiness
• dizziness
• weakness
• fatigue
• headache
• insomnia
• nausea

Less common side effects include:

• confusion
• low blood pressure (hypotension)
• constipation
• frequent urination

This is not a complete list of baclofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• benzodiazepines (drugs used to treat anxiety, panic attacks and other conditions) such as alprazolam (Xanax), chlordiazepoxide (Librium), clobazam (Onfi), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), temazepam (Restoril) and others
• opioids (narcotic pain medicines) such as hydrocodone (in Lortab, in Vicodin), morphine (Avinza, Kadian, MS Contin, others), oxycodone (Oxycontin)
• tricyclic antidepressants such as amitriptyline, amoxapine, desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• sleep medicines such as eszopiclone (Lunesta), ramelteon (Rozerem), zaleplon (Sonata), zolpidem (Ambien)
• muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Amrix, Flexeril), dantrolene (Dantrium) or metaxalone (Skelaxin)
• other medicines that cause sedation

This is not a complete list of baclofen drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Serious side effects have been reported including:

• hallucinations and seizures after stopping medication too quickly. Withdrawal symptoms can occur if baclofen is stopped too quickly. Talk to your doctor before stopping this medication, especially if you have been taking it for a long time. For intrathecal baclofen, see "Baclofen FDA Warning" section.
• increased risk of seizures. Baclofen can increase risk of seizures, especially in those with seizure disorders (epilepsy).
• worsening mental illness. Talk to your doctor about mental illness.

Dose reduction may be necessary in patients with kidney disease. This medication is excreted by the kidneys. If you have kidney disease, your doctor may recommend a lower dose.

People who have suffered a stroke may be less able to tolerate baclofen and may not benefit from taking it.

Do not take baclofen if you are allergic to any of its ingredients.

Baclofen can cause drowsiness. Do not drive or operate machinery until you know how it affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of baclofen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking baclofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in baclofen
• have kidney disease
• have epilepsy or seizures
• have cerebral palsy
• have Parkinson's disease
• have a psychiatric condition
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Baclofen falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Baclofen, when taken orally, has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from baclofen, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take baclofen exactly as prescribed.

Oral:

• Baclofen comes in tablet form. It is usually taken 3 or 4 times daily, with or without food. 
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of baclofen at the same time.

Injectable:

• Baclofen is also available in an injectable form to be used in more severe cases. It is given through a pump into the spinal fluid.

Take baclofen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The baclofen dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Oral:

Your doctor will likely start you off on a low dosage and gradually increase your dose as necessary. The recommended dosage schedule is:

• 5 mg three times daily for 3 days
• 10 mg three times daily for 3 days
• 15 mg three times daily for 3 days
• 20 mg three times daily for 3 days

The maximum daily oral (by mouth) dose is 80 mg (20 mg four times daily).

Injectable:

A doctor will surgically place the pump that will deliver the dose of the medication. The dose of intrathecal baclofen will be different for different patients and will depend on the type of muscle tightness that you have.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature.
• Keep this and all medications out of the reach of children.

Injectable:

Abrupt discontinuation of intrathecal (into the spine) baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.  

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.  Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information.