OZOBAX

OZOBAX- baclofen solution
Metacel Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

OZOBAX is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Limitations of Use
OZOBAX is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Initiate OZOBAX with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability:

5 mL (5 mg) three times a day for three days

10 mL (10 mg) three times a day for three days

15 mL (15 mg) three times a day for three days

20 mL (20 mg) three times a day for three days

Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four times a day).

2.2 Discontinuation of OZOBAX

When discontinuing OZOBAX, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

Oral Solution: 5 mg/5 mL baclofen as a clear, colorless solution with a grape aroma

4 CONTRAINDICATIONS

OZOBAX is contraindicated in patients with hypersensitivity to baclofen.

5 WARNINGS AND PRECAUTIONS

5.1 Adverse Reactions from Abrupt Withdrawal of OZOBAX

Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, 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. Therefore, reduce the dosage slowly when OZOBAX is discontinued, unless the clinical situation justifies a rapid withdrawal.

5.2 Neonatal Withdrawal Symptoms

Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and OZOBAX is continued during pregnancy, gradually reduce the dosage and discontinue OZOBAX before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal.

5.3 Drowsiness and Sedation

Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in OZOBAX [see Adverse Reactions (6.1)]. Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting OZOBAX or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of OZOBAX may be additive to those of alcohol and other CNS depressants.

5.4 Poor Tolerability in Stroke Patients

OZOBAX should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

5.5 Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States

OZOBAX should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with OZOBAX, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration.

5.6 Exacerbation of Autonomic Dysreflexia

OZOBAX should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of OZOBAX may cause an autonomic dysreflexic episode.

5.7 Exacerbation of Epilepsy

OZOBAX should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen.

5.8 Posture and Balance Effects

OZOBAX should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

5.9 Ovarian Cysts

A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year. In most cases, these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Adverse Reactions from Abrupt Withdrawal of OZOBAX [see Warnings and Precautions (5.1)]
  • Neonatal Withdrawal Symptoms [see Warnings and Precautions (5.2)]
  • Drowsiness and Sedation [see Warnings and Precautions (5.3)]
  • Poor Tolerability in Stroke Patients [see Warnings and Precautions (5.4)]
  • Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions (5.5)]
  • Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions (5.6)]
  • Exacerbation of Epilepsy [see Warnings and Precautions (5.7)]
  • Posture and Balance Effects [see Warnings and Precautions (5.8)]
  • Ovarian Cysts [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of ≥1% are listed in Table 1.

Table 1. Common (≥1%) Adverse Reactions in Patients Treated with Baclofen for Spasticity

ADVERSE REACTION

PERCENT

Drowsiness

10-63%

Dizziness

5-15%

Weakness

5-15%

Nausea

4-12%

Confusion

1-11%

Hypotension

0-9%

Headache

4-8%

Insomnia

2-7%

Constipation

2-6%

Urinary Frequency

2-6%

Fatigue

2-4%

The following adverse reactions not included in Table 1, classified by body system, were also reported:

Neuropsychiatric: euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure

Cardiovascular: dyspnea, palpitation, chest pain, syncope

Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool

Genitourinary: enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria

Other: rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion

The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

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