Bamifen Thận trọng

Psychiatric and nervous system disorders: Porphyria, history of alcoholism, hypertension, psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson's disease may be exacerbated by treatment with baclofen. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Suicide and suicide-related events have been reported in patients treated with baclofen. In most cases, the patients had additional risk factors associated with an increased risk of suicide including alcohol use disorder, depression and/or a history of previous suicide attempts. Close supervision of patients with additional risk factors for suicide should accompany drug therapy. Patients (and caregivers of patients) should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Cases of misuse, abuse and dependence have been reported with baclofen. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of baclofen misuse, abuse or dependence e.g. dose escalation, drug-seeking behaviour, development of tolerance.
Epilepsy: Baclofen may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.
Others: Baclofen should be used with extreme care in patients already receiving antihypertensive therapy.
Baclofen should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment.
Since unwanted effects are more likely to occur, a cautious dosage schedule should be adopted in elderly and patients with spasticity of cerebral origin.
Renal impairment: Signs of overdose have been observed in patients with renal impairment taking baclofen at doses of more than 5 mg per day. Baclofen should be used with caution in patients with renal insufficiency and should only be administered to patients with end-stage renal failure (GFR <15 ml/min) only if the expected benefit outweighs the potential risk. Neurological signs and symptoms of overdose including clinical manifestations of toxic encephalopathy (e.g. confusion, disorientation, somnolence and depressed level of consciousness) have been observed in patients with renal impairment taking oral baclofen at doses of more than 5 mg per day and at doses of 5 mg per day in patients with end-stage renal failure being treated with chronic haemodialysis. Patients with impaired renal function should be closely monitored for prompt diagnosis of early symptoms of toxicity.
Cases of baclofen toxicity have been reported in patients with acute renal failure.
Particular caution is required when combining baclofen with drugs or medicinal products that can significantly affect renal function. Renal function should be closely monitored and baclofen daily dosage adjusted accordingly to prevent baclofen toxicity.
Besides discontinuing treatment, unscheduled haemodialysis might be considered as a treatment alternative in patients with severe baclofen toxicity. Haemodialysis effectively removes baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients.
Urinary disorders: Under treatment with baclofen, neurogenic disturbances affecting emptying of the bladder may show an improvement. In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such patients.
Laboratory tests: In rare instances, elevated aspartate aminotransferase, alkaline phosphatase and glucose levels in serum have been recorded. Appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred.
Abrupt withdrawal: Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks. Anxiety and confusional state, delirium, hallucination, psychotic disorder, mania or paranoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity as a rebound phenomenon have been reported with abrupt withdrawal of baclofen, especially after long term medication.
Neonatal convulsions have been reported after intrauterine exposure to oral baclofen.
Treatment should always (unless serious adverse effects occur) therefore be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.
Posture and balance: Baclofen should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion.
Effects on Ability to Drive and Use Machines: Baclofen may be associated with adverse effects such as dizziness, sedation, somnolence and visual impairment which may impair the patient's reaction. Patients experiencing these adverse reactions should be advised to refrain from driving or operating machinery.
Use in Children: There is very limited clinical data on the use of baclofen in children under the age of one year. Use in this patient population should be based on the physician's consideration of individual benefit and risk of therapy.