Recommended Topic Related To:

Lioresal Intrathecal

"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.

Ameridos"...

Lioresal Intrathecal

Lioresal Intrathecal

Lioresal Intrathecal Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lioresal-Intrathecal (baclofen) Injection is a muscle relaxant and antispastic used to treat stiff or rigid muscles (spasticity). This medication is available in generic form. Common side effects include sleepiness, dizziness, nausea, low blood pressure, headache, convulsions, and decreased muscle tone.

Adult and pediatric patients are first given a screening dose of 50 mcg. If a positive effect is observed, the dose will be gradually increased. Lioresal-Intrathecal may interact with morphine. Tell your doctor all medications and supplements you use. During pregnancy, Lioresal-Intrathecal should be taken only if prescribed. Lioresal-Intrathecal passes into breast milk. Effects on a nursing infant are unknown. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Lioresal-Intrathecal (baclofen) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lioresal Intrathecal FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Baclofen has been shown to have general CNS depressant properties, causing sedation, somnolence, and respiratory and cardiovascular depression.

The most commonly reported adverse events with LIORESAL Intrathecal (baclofen injection) in clinical trials were drowsiness, weakness in the lower extremities, dizziness and seizures.

Adverse drug reactions from clinical trials are listed in the table below according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common ( ≥ 1/10); common ( ≥ 1/100, < 1/10); uncommon ( ≥ 1/1,000, < 1/100); rare ( ≥ 1/10,000, < 1/1,000); very rare ( < 1/10,000), including isolated reports.

Adverse events associated with the delivery system (e.g. mass at the tip of the catheter, catheter dislocation with possible complications, pocket infection, meningitis, overdose due to wrong manipulation of the device) have been reported, whereby in some cases a causal relationship with baclofen cannot be excluded (see WARNINGS). These are in addition to those listed below. In a fatal case of a child (causality with baclofen uncertain), inflammatory signs in the posterior horns and signs of arachnoiditis in proximity of the catheter tip were observed. This corresponds to observations in dogs, where chronic inflammatory reactions to the foreign body of the catheter were observed, independently of baclofen concentration.

Incidence of Most Frequent Adverse Events in US Clinical Trials

Adverse Event Number of patients reporting events (%)
Screening
(N= 244)
Titration
(N= 214)
Maintenance
(N=214)
Somnolence 13 (5.3%) 11(5.1%) 18 (8.4%)
Weakness, Lower Extremities 1 (0.4%) 11(5.1%) 15 (7.0%)
Dizziness 6 (2.4%) 5 (2.3%) 12(5.6%)
Convulsion 1 (0.4%) 4 (1.9%) 11 (5.1%)
Headache 0 (0%) 3 (1.4%) 9 (4.2%)
Nausea/Vomiting 3 (1.2%) 5 (2.3%) 3 (1.4%)
Numbness/Itching/Tingling 2 (0.8%) 1 (0.5%) 8 (3.7%)
Hypotension 3 (1.2%) 0 (0%) 5 (2.3%)
Vision Blurred 0 (0%) 2 (0.9%) 5 (2.3%)
Constipation 0 (0%) 2 (0.9%) 5 (2.3%)
Hypotonia 2 (0.8%) 3 (1.4%) 2 (0.9%)
Dysarthria 0 (0%) 1 (0.5%) 6 (2.8%)
Coma (Overdose) 0 (0%) 4 (1.9%) 3 (1.4%)
Lethargy 1 (0.4%) 0 (0%) 4 (1.9%)
Weakness, Upper Extremities 1 (0.4%) 0 (0%) 4 (1.9%)
Hypertension 1 (0.4%) 2 (0.9%) 2 (0.9%)
Dyspnea 1 (0.4%) 2 (0.9%) 1 (0.5%)

In addition to the more common adverse events reported above, the following adverse events were observed during clinical trials elsewhere or reported by clinicians.

Metabolism and nutritional disorders

Uncommon: Dehydration, weight loss, albuminuria and hyperglycemia

Psychiatric disorders

Common: Depression, anxiety, agitation

Uncommon: Suicide ideation and suicide attempt, hallucinations, paranoia, euphoric mood

Nervous system disorders

Common: Confusional state, disorientation, insomnia, sedation, paresthesia, fatigue, lethargy

Uncommon: nystagmus, ataxia, memory impairment.

Eye disorders

Common: Accommodation disorder, diplopia

Cardiac disorders

Uncommon: Bradycardia

Rare: pulmonary embolism.

Vascular disorders

Uncommon: Deep vein thrombosis, flushing, pallor

Gastrointestinal disorders

Common: Dry mouth, diarrhea, decreased appetite, increased salivation

Uncommon: Ileus, hypogeusia, dysphagia

Respiratory, thoracic and mediastinal disorders

Common: Respiratory depression, pneumonia,

Renal and urinary disorders

Common: urinary incontinence, urinary retention.

Reproduction system and breast disorders

Common: Sexual dysfunction

Skin and subcutaneous tissue disorders

Common: Urticaria, pruritus, facial and/or peripheral edema

Uncommon: Alopecia, hyperhidrosis

Musculoskeletal and connective tissue disorders

Common: Hypertonia

General disorders and administration site conditions

Common: Asthenia, pyrexia, chills, pain

Uncommon: Hypothermia

Adverse Drug Reactions From Spontaneous Reports And Literature Cases (frequency not known)

The following adverse drug reactions have been derived from post-marketing experience with LIORESAL Intrathecal via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Nervous system disorders: dysphoria

Respiratory, thoracic and mediastinal disorders: bradypnea

Read the entire FDA prescribing information for Lioresal Intrathecal (Baclofen Injection) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Chronic Pain/Back Pain

Find tips and advances in treatment.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations