Baclofen


Generic Medicine Info
Administration
Should be taken with food.
Contraindications
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
Muscle Relaxants
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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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