Baclofen is indicated for the management of spasticity associated with:

• Multiple sclerosis
• Flexor spasms, accompanied by pain, clonus, and muscle rigidity
• Skeletal muscle spasm due to rheumatic disorders
• Spinal cord injuries and other spinal cord diseases
• Cerebrovascular disorders, as well as neoplastic or degenerative diseases of the brain

Baclofen acts by inhibiting both monosynaptic and polysynaptic reflexes at the spinal cord level through stimulation of GABA receptors. This action reduces the release of excitatory neurotransmitters such as glutamate and aspartate. It may also exert effects within the central nervous system, leading to CNS depression. Additionally, baclofen has analgesic (antinociceptive) properties.

Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

• Co-administration of baclofen with central nervous system (CNS) depressants, alcohol, or opioids may enhance sedative effects and increase the risk of respiratory depression.
• Concurrent use with antihypertensive agents may lead to an excessive drop in blood pressure; therefore, adjustment of antihypertensive dosage may be required.
• Use with tricyclic antidepressants may intensify the effects of baclofen, resulting in marked muscle hypotonia.
• In patients with Parkinson’s disease receiving levodopa and carbidopa, baclofen has been associated with mental confusion, hallucinations, headache, nausea, and agitation.
• Simultaneous use with monoamine oxidase (MAO) inhibitors may increase CNS depressant effects; dose adjustment and caution are advised.
• Caution is also required when baclofen is used with magnesium sulfate or other neuromuscular blocking agents due to potential additive effects.

Baclofen is contraindicated in patients with known hypersensitivity to baclofen or any of its components.

The most commonly reported adverse effects include transient drowsiness, daytime sedation, dizziness, weakness, and fatigue.

Central Nervous System: Headache and insomnia may occur; rarely, euphoria, depression, confusion, hallucinations, paraesthesia, nightmares, tremor, rigidity, ataxia, blurred vision, nystagmus, diplopia, dysarthria, seizures, and respiratory depression may be observed.

Cardiovascular: Hypotension is relatively common; rare effects include dyspnoea, palpitations, chest pain, and syncope.

Gastrointestinal: Nausea and constipation are common; less frequently, dry mouth, anorexia, taste disturbances, abdominal pain, vomiting, diarrhea, and occult blood in stool may occur.

Genitourinary: Urinary frequency may occur; rarely, urinary retention, enuresis, dysuria, impotence, ejaculatory dysfunction, nocturia, and hematuria may be seen.

Other: Rash, itching, ankle swelling, excessive sweating, weight gain, nasal congestion, visual disturbances, liver function abnormalities, and paradoxical increase in spasticity may occur. Severe muscle hypotonia may impair movement but usually improves after dose adjustment.

Baclofen is classified as Pregnancy Category B3. Its safety during pregnancy has not been fully established. It crosses the placenta and should be used only if the potential benefits outweigh the risks. Baclofen is excreted into breast milk in small amounts. Available data suggest that these levels are unlikely to cause harmful effects in the infant.

• Lower doses (around 5 mg daily) are recommended in patients with impaired renal function or those undergoing long-term hemodialysis.
• Patients with underlying psychiatric conditions such as psychosis, schizophrenia, depression, mania, or confusion should be treated cautiously and closely monitored, as symptoms may worsen.
• In patients with epilepsy, baclofen may be used under strict supervision while maintaining adequate anticonvulsant therapy. Baclofen may lower the seizure threshold, and seizures have been reported after abrupt discontinuation or overdose.
• Use baclofen cautiously in patients with a history of peptic ulcer disease, cerebrovascular disorders, or hepatic, renal, or respiratory impairment.
• Close monitoring of respiratory and cardiovascular function is necessary, particularly in patients with cardiopulmonary disease or respiratory muscle weakness.
• Baclofen may improve neurogenic bladder dysfunction; however, in patients with pre-existing sphincter hypertonia, acute urinary retention may occur. Caution is advised in such cases.
• Patients with a history of stroke may have limited benefit and reduced tolerance to baclofen.
• Regular laboratory monitoring is recommended in patients with liver disease or diabetes mellitus to detect any drug-related changes.

In cases of severe overdose, gastric lavage may be required as part of emergency management.

Centrally acting skeletal muscle relaxants.

Store below 30°C, protected from light and moisture. Keep out of reach of children.