Baclofen

What is Baclofen?

• Baclofen (Kemstro; Lioresal; Ozobax) is a muscle relaxant and antispastic is used for spasticity in patients with multiple sclerosis, spinal cord injuries, or other diseases.

Baclofen

Baclofen skeletal

Baclofen Enantiomers

What are the uses of this medicine?

• Baclofen (Kemstro; Lioresal; Ozobax) is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis.
• Baclofen may also be used for signs and symptoms of spasticity in patients with spinal cord injuries and other spinal cord diseases.

Limitations of use:

• Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
• The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

How does this medicine work?

• Baclofen (bak' loe fen) is a gamma-amino butyric acid (GABA) derivative that acts as an agonist of the GABA B receptor, thereby activating potassium channels and reducing calcium conductance leading to hypotonia and muscle relaxation.
• Baclofen acts primarily at the level of the spinal cord, inhibiting synaptic reflexes.
• Baclofen reduces the number and severity of muscle spasms and relieves pain, clonus and muscle rigidity due to spasticity.
• Baclofen is indicated primarily for treatment of spasticity from spinal cord injuries and multiple sclerosis.
• It has been used off label as adjunctive therapy to help with alcohol abstinence and withdrawal.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Hypersensitivity to baclofen

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antidepressants, medications for anxiety, medications for mental illness, medications for seizures, sedatives, sleeping pills, or tranquilizers.

Is this medicine FDA approved?

• Baclofen was approved for use in the United States in 1977 and is widely used with several million prescriptions filled yearly.

How should this medicine be used?

Recommended dosage:

• Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).

The following dosage titration schedule is suggested:

• 5 mg t.i.d. for 3 days
• 10 mg t.i.d. for 3 days
• 15 mg t.i.d. for 3 days
• 20 mg t.i.d. for 3 days
• Thereafter additional increases may be necessary but the total dose should not exceed a maximum of 80 mg daily (20 mg q.i.d).

Administration:

• Baclofen comes as a tablet and a solution (liquid) to take by mouth.
• It usually is taken 3 times a day at evenly spaced intervals.
• Use an oral syringe (measuring device) to accurately measure and take your dose of baclofen solution.
• Continue to take baclofen even if you feel well.
• Do not stop taking baclofen without talking to your doctor, especially if you have taken large doses for a long time.
• Abruptly stopping this medication can cause seizures, fever, confusion, muscle stiffness, or hallucinations.
• Your doctor probably will want to decrease your dose gradually.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and a solution (liquid)

This medicine is available in fallowing brand namesː

• Kemstro; Lioresal; Ozobax

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness
• dizziness
• weakness
• fatigue
• Hypotension
• Nausea
• constipation
• Confusion
• headache
• insomnia
• Urinary frequency
• Instances of rash
• pruritis
• ankle edema
• excessive perspiration
• weight gain
• nasal congestion

What special precautions should I follow?

• Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
• Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
• Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
• Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness.
• Ask your doctor about the safe use of alcoholic beverages while you are taking baclofen. Alcohol can make the side effects from baclofen worse.
• Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
• It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
• Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug.
• Baclofen has not been linked to rare instances of mild, self-limited, clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures

Management of overdosage:

• In the alert patient, empty the stomach promptly by induced emesis followed by lavage.
• In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis).
• Maintain adequate respiratory exchange, do not use respiratory stimulants.

Can this medicine be used in pregnancy?

• There are no studies in pregnant women.
• Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safe use of baclofen in children under age 12 has not been established, and it is therefore, not recommended for use in children.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• Baclofen

Inactive Ingredients:

• pregelatinized starch
• colloidal silicon dioxide
• magnesium stearate
• microcrystalline cellulose
• sodium starch glycolate

Who manufactures and distributes this medicine?

Packager:

• CARACO PHARMACEUTICAL LABORATORIES, LTD.

What should I know about storage and disposal of this medication?

• Store at 20 - 25° C (68 - 77° F).

Muscle relaxants

• Baclofen
• Carisoprodol
• Chlorzoxazone
• Cyclobenzaprine
• Dantrolene
• Metaxalone
• Methocarbamol
• Orphenadrine
• Tizanidine

• Dailymed label info on Baclofen
• FDA Baclofen

Muscle relaxants

• Baclofen
• Carisoprodol
• Chlorzoxazone
• Cyclobenzaprine
• Dantrolene
• Metaxalone
• Methocarbamol
• Orphenadrine
• Tizanidine