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LIORESAL (BACLOFEN) INTRATHECAL INJECTION PRESCRIBING INFORMATION

DESCRIPTION

Lioresal Intrathecal (baclofen injection) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid.
Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.
Lioresal Intrathecal is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37 C and compatible with CSF. Each milliliter of Lioresal Intrathecal contains baclofen U.S.P. 50 mcg, 500 mcg or 2000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0-7.0. Each ampule is intended for single use only. Discard any unused portion. Do not autoclave.


CLINICAL PHARMACOLOGY

The precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effects by stimulation of the GABA(B) receptor subtype.

Lioresal Intrathecal when introduced directly into the intrathecal space permits effective CSF concentrations to be achieved with resultant plasma concentrations 100 times less than those occurring with oral administration.

In people, as well as in animals, baclofen has been shown to have general CNS depressant prop- erties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.


INDICATIONS

  • Lioresal injection indications


    CONTRAINDICATIONS

    Hypersensitivity to baclofen. Lioresal Intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.


    WARNINGS

  • Lioresal injection warnings


    WITHDRAWAL

  • Lioresal injection withdrawal


    PRECAUTIONS

    Children should be of sufficient body mass to accommodate the implantable pump for chronic infu- sion. Please consult pump manufacturer's manual for specific recommendations.
    Safety and effectiveness in pediatric patients below the age of 4 have not been established.


    ADVERSE REACTIONS

  • Lioresal injection adverse reactions


    OVERDOSE

    Symptoms of Lioresal Intrathecal Overdose: drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, hypothermia, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hr. duration. In most cases reported, coma was reversible without sequelae after drug was discontinued. Symptoms of Lioresal Intrathecal overdose were reported in a sensitive adult patient after receiving a 25 mcg intrathecal bolus.

    Treatment Suggestions for Overdose:
    There is no specific antidote for treating overdoses of Lioresal Intrathecal (baclofen injection); however, the following steps should ordinarily be undertaken: 1) Residual Lioresal Intrathecal solution should be removed from the pump as soon as possible. 2) Patients with respiratory depression should be intubated if necessary, until the drug is eliminated.

    If lumbar puncture is not contraindicated, consideration should be given to withdrawing 30- 40 ml of CSF to reduce CSF baclofen concentration.


    DOSAGE AND ADMINISTRATION

  • Lioresal injection dosage and administration


    HOW SUPPLIED

    Lioresal Intrathecal (baclofen injection) is available in single use ampules of 10 mg/20 ml (500 mcg/ ml) or 10 mg/ 5 ml (2000 mcg/ml) or 40 mg/20 ml (2000 mcg/ml) packaged in a Refill Kit for intrathecal administration. For screening, Lioresal Intrathecal is available in a single use ampule of 0.05 mg/ 1 ml.


    STORAGE

    Does not require refrigeration.
    Do not store above 86 F (30 C).
    Do not freeze.
    Do not heat sterilize.

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