Ozobax - baclofen oral solution
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Multiple Sclerosis & Spasticity

What is Multiple Sclerosis?1

MS is a chronic illness involving the central nervous system (CNS). The immune system attacks the protective sheath (myelin) that covers nerve fibers. This damages the nerve fibers and surrounding specialized cells which alters or stops the communication process between the brain and the rest of the body. Most people are diagnosed with MS between the ages of 20 and 50 years of age and women are two to three times more likely to be diagnosed than men.

Among the most common symptoms of MS are spasticity, numbness or weakness in limbs, tremors, fatigue, bowel problems, and cognitive changes such as depression.

Spasticity in Multiple Sclerosis Patients2

Flexor and extensor spasticity is very common in MS patients.

Flexor spasticity is the involuntary bending of the hips or knees, primarily involving the hamstring muscles on the back of the upper leg.

Extensor spasticity is the involuntary straightening of the legs.

Spasticity in the arms may also occur, but it is less common in people with MS.

Other types of spasms associated with MS are: clonus, the involuntary flexing and relaxing of muscles; and muscle rigidity or stiffness.

References:

  1. Mayo Clinic MS Symptoms: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269. Accessed Dec. 15, 2019
  2. National Multiple Sclerosis Society: https://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms/Spasticity

Important Safety Information

OZOBAX® is contraindicated in patients with hypersensitivity to baclofen.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when OZOBAX is discontinued.

Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX before delivery.

OZOBAX can cause drowsiness and sedation. Patients should avoid the operation of machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX may be additive to those of alcohol and other CNS depressants.

OZOBAX should be used with caution in patients who have had a stroke.

OZOBAX can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.

The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency and fatigue.

You are encouraged to report adverse reactions to Metacel Pharmaceuticals, LLC at 1-833-469-6229 or to the FDA:  www.fda.gov/medwatch or 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.