PMS-Baclofen

Baclofen

Alleviation of signs & symptoms of spasticity resulting from multiple sclerosis. Patients w/ spinal cord injuries & other spinal cord diseases.

Initially 15 mg daily in divided doses. Dosage titration schedule: 5 mg tds then gradually increase to 10 mg tds, 15 mg tds & 20 mg tds at 3-day intervals. Additional increases may be necessary thereafter. Max: 80 mg daily (20 mg qds).

Should be taken with food.

Hypersensitivity.

Avoid abrupt w/drawal of therapy. Patients w/ compromised resp function, resp or neurological disease, renal impairment & elderly are at higher risk of experiencing severe adverse effects. Concomitant use w/ opioids may result in resp depression, profound sedation, syncope & death; medications that may impact renal function. Additive effect w/ alcohol & other CNS depressants. Closely monitor for prompt diagnosis of early signs & symptoms of toxicity (eg, somnolence, lethargy); renal function. Baclofen has not significantly benefited patients w/ stroke. Exercise extreme caution in patients w/ epilepsy or history of convulsive disorders. Close surveillance of patients suffering from psychiatric disorders (eg, psychosis, schizophrenia or confusional states). Risk factors associated w/ an increased risk of suicide including history of suicidal behaviour, depression, alcohol/substance abuse &/or concomitant use of medications known to increase risk of suicide; monitor for clinical worsening, suicidal behaviour/thoughts or unusual behavioural changes. History of substance abuse; monitor for symptoms of misuse, abuse or dependence (eg, dose escalation, drug-seeking behavior, tolerance development). Patients who use spasticity to sustain upright posture & balance in locomotion; or to obtain increased function. Patients w/ or history of peptic ulcer; resp failure; underlying bladder sphincter hypertonia. Perform periodic lab tests in patients w/ liver diseases or DM. Possible elevated SGOT, alkaline phosphatase & glucose levels. Severe hepatic impairment. Renal impairment. Advise patients experiencing adverse effects (eg, dizziness, sedation, somnolence & visual impairment) to refrain from driving or using machines. Women of childbearing potential. Pregnancy & lactation; nursing should not be undertaken while on therapy. Carefully monitor neonates w/ risk of intrauterine exposure to PMS-Baclofen for signs of w/drawal (eg, irritability, high-pitched crying, tremor, hypertonicity, excessive sucking, disordered sleep, hyperthermia, mottling & postnatal convulsions). Childn <12 yr. Elderly ≥65 yr; w/ cerebrovascular disorders.

Transient somnolence, sedation, dizziness, weakness & fatigue. Nausea. Accomodation disorders, visual impairment; decreased cardiac output; hypotension; constipation, GI disorders, retching, vomiting, diarrhea; rash, hyperhidrosis, pruritus; pollakiuria, enuresis, dysuria; ankle edema.

CNS effects may be potentiated by anesth agents. Pharmacological effects may be potentiated by TCAs, resulting in pronounced muscular hypotonia. Concomitant use w/ TCAs may cause sedation & drowsiness. Aggravated hyperkinetic symptoms w/ lithium. Increased CNS-depressant effects w/ MAOIs. Increased fall in BP w/ antihypertensives. Possible mental confusion, hallucinations, headache, nausea & agitation; worsened symptoms of Parkinsonism when used concomitantly w/ levodopa/carbidopa. Possible increased blood glucose conc; adjust dose of antidiabetic agents (oral & insulin) if necessary when used in combination. Synergistic effect w/ Mg sulfate. Excretion may be reduced by drugs that can significantly impact renal function (eg, memantine, NSAIDS). Increased sedation & risk of resp depression w/ other drugs causing CNS depression including other muscle relaxants (eg, tizanidine), synthetic opiates, hypnotics, anxiolytics or alcohol. Hypotension may occur w/ concomitant use of morphine & intrathecal baclofen.

Muscle Relaxants

M03BX01 - baclofen ; Belongs to the class of other centrally-acting muscle relaxants.

POM