baclofen

Generic Name: baclofen (BAK loe fen)
Brand names: Lioresal, Lioresal Intrathecal

What is baclofen?

Baclofen is a muscle relaxer and an antispastic agent.

Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.

Baclofen may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about baclofen?

Baclofen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of baclofen. Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

What should I discuss with my healthcare provider before taking baclofen?

Do not use this medication if you are allergic to baclofen.

Before taking baclofen, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;
epilepsy or other seizure disorder; or
a history of stroke or blood clots.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether baclofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

Do not give this medication to a child younger than 12 years old.

How should I take baclofen?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

You may take baclofen with or without food.

Call your doctor if your muscle symptoms do not improve after 2 weeks of taking this medication.

Store baclofen at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include muscle weakness, vomiting, drowsiness, dilated or pinpoint pupils, weak or shallow breathing, fainting, or coma.

What should I avoid while taking baclofen?

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by baclofen.

Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

Baclofen side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

seizure (convulsions);
confusion, hallucinations; or
an uneven heartbeat.

Less serious side effects may include:

drowsiness, dizziness, weakness, tired feeling;
headache;
sleep problems (insomnia);
nausea, constipation; or
urinating more often than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Baclofen Dosing Information

Usual Adult Dose for Muscle Spasm:

Oral: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

Usual Adult Dose for Trigeminal Neuralgia:

Usual Adult Dose for Hiccups:

Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Usual Adult Dose for Cerebral Spasticity:

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
If a positive response has occurred following a test dose, an intrathecal infusion device may be surgically implanted.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

What other drugs will affect baclofen?

There may be other drugs that can affect baclofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about baclofen.

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
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