Concise Prescribing Info
Severe chronic spasticity.
Dosage/Direction for Use
Adult: PO Initial: 15 mg/day preferably in divided doses, may be increased gradually according to individual requirements. Suggested regimen: 5 mg tid for 3 days, increased to 10 mg tid for 3 days, then increased to 15 mg tid for 3 days, until increased to 20 mg tid for 3 days. Re-assess treatment if therapeutic effect is not apparent within 6 weeks of achieving max dosage. Intrathecal Screening: Initial: 25 mcg or 50 mcg via spinal catheter or lumbar puncture over at least 1 minute, increase the dose by 25 mcg increments at intervals of at least 24 hours until response of approx 4-8 hours duration is obtained. Dose-titration: The initial total daily dose via infusion is determined by doubling the test dose which gave a significant response administered over 24 hours. For patients with response lasting >12 hours, the unchanged test dose may be given over 24 hours without any dose increase. After the 1st 24 hours, slowly adjust dosage in increments of 10-30% of the previous daily dose for spasticity of spinal origin, or 5-15% of the previous daily dose for spasticity of cerebral origin once every 24 hours for programmable pumps, or every 48 hours for non-programmable multi-dose reservoir pumps, until the desired clinical effect is achieved. Maintenance dose range: 12-2,003 mcg/day for spasticity of spinal origin; 22-1,400 mcg/day for spasticity of cerebral origin.
Should be taken with food.
Oral: Peptic ulceration. Intrathecal: Not intended for IV, IM, SC or epidural administration.
Special Precautions
Patients with psychotic disorders, schizophrenia, depressive or manic disorders, confusional states, Parkinson's disease, epilepsy or history of seizure disorders, cerebrovascular or respiratory insufficiency, history of peptic ulcers, decreased gastrointestinal motility and/or obstructive disorders, pre-existing sphincter hypertonia, diabetes mellitus, history of autonomic dysreflexia (intrathecal), spasticity of cerebral origin, or spasticity needed to sustain upright posture and balance in locomotion. Not indicated for treatment of spasticity associated with rheumatic disorders. Avoid abrupt withdrawal. Renal impairment including ESRD. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, sedation, somnolence or visual impairment, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal and liver function; EEG regularly in patients with epilepsy.
Adverse Reactions
Significant: Respiratory depression, intrathecal mass formation, acute urinary retention, CNS depression; oral: drug withdrawal syndrome (e.g. hyperactive state with rapid uncontrolled spasms, hyperthermia, autonomic dysreflexia, infection or sepsis, malignant hyperthermia). Rarely, elevated AST and serum alkaline phosphatase, increased blood glucose levels. Cardiac disorders: Bradycardia. Eye disorders: Accommodation disorder, blurred vision, nystagmus, diplopia. Gastrointestinal disorders: Nausea, vomiting, dry mouth, constipation, diarrhoea, increased salivation. General disorders and administration site conditions: Fatigue, ataxia, lethargy, asthenia, pyrexia, pain, chills, facial or peripheral oedema. Investigations: Cardiac output decreased. Metabolism and nutrition disorders: Dehydration, decreased appetite. Musculoskeletal and connective tissue disorders: Muscle weakness, myalgia, hypotonia. Nervous system disorders: Sedation, somnolence, dizziness, headache, tremor, paraesthesia, memory impairment. Psychiatric disorders: Confusional state, insomnia, hallucination, depression, anxiety, agitation, euphoric mood, dysarthria, nightmares. Renal and urinary disorders: Pollakiuria, enuresis, dysuria, urinary incontinence. Reproductive system and breast disorders: Sexual dysfunction (intrathecal). Respiratory, thoracic and mediastinal disorders: Dyspnoea, pneumonia. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis, pruritus. Vascular disorders: Hypotension, flushing, pallor.
Potentially Fatal: Intrathecal: Drug withdrawal syndrome (e.g. altered mental status, exaggerated rebound spasticity, muscle rigidity, rarely rhabdomyolysis, multiple organ-system failure, and death).
Drug Interactions
Increased risk of adverse events (e.g. nausea, mental confusion, hallucination, agitation) of levodopa/carbidopa. Increased sedation and risk of respiratory depression with other muscle relaxants (e.g. tizanidine), synthetic opiates, CNS depressants, analgesics, neuroleptics, barbiturates, benzodiazepines, anxiolytics. Increased risk of hypotension and dyspnoea with morphine. May potentiate effects of TCAs resulting in pronounced muscular hypotonia. Increased risk of cardiac disturbances and seizures with general anaesthetics (e.g. fentanyl, propofol). May aggravate hyperkinetic symptoms with lithium. Increased risk of hypotension with antihypertensives. May increase risk of toxic effects with other drugs that significantly affect renal function.
CIMS Class
ATC Classification
M03BX01 - baclofen ; Belongs to the class of other centrally-acting muscle relaxants.
Disclaimer: This information is independently developed by CIMS based on baclofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by
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