Indications

Flexilax (Baclofen) is a centrally acting skeletal muscle relaxant used to treat spasticity and muscle spasms resulting from various conditions:

• Multiple sclerosis.
• Spinal cord injuries and other spinal cord diseases.
• Cerebrovascular accidents or degenerative brain diseases.
• Rheumatic disorders. It helps to alleviate flexor spasms, clonus, and muscular rigidity, as well as the concomitant pain.

Pharmacology

Baclofen acts at the spinal level by stimulating GABAB receptors. This action inhibits the release of excitatory neurotransmitters like glutamate and aspartate, thereby suppressing both monosynaptic and polysynaptic reflexes. It also has a central nervous system (CNS) depressant effect and provides pain relief.

Dosage & Administration

• Adults and Children over 10 years: Start with 5 mg three times daily, preferably with or after food. The dose is gradually increased, with a maximum daily dose of 100 mg.
• Children under 10 years: Treatment starts with 2.5 mg four times daily, with the dose adjusted as needed. Daily maintenance doses range from 10-20 mg for children 1-2 years old to 30-60 mg for children 6-10 years old.

Interaction

• CNS Depressants (e.g., alcohol, synthetic opiates): Concomitant use can lead to increased sedation and a higher risk of respiratory depression.
• Antihypertensives: The combination may cause an increased fall in blood pressure, requiring dosage adjustment of the antihypertensive medication.
• Tricyclic Antidepressants: May potentiate the effects of Flexilax, leading to pronounced muscular hypotonia.
• Levodopa and Carbidopa (for Parkinson's disease): Concurrent use may cause mental confusion, hallucinations, and other side effects.
• MAO Inhibitors: May increase CNS depressant effects.

Contraindications

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

Side Effects

Common side effects include drowsiness, dizziness, weakness, and fatigue. Other reported side effects include headache, insomnia, nausea, constipation, urinary frequency, and hypotension. In rare cases, more serious side effects like epileptic seizures and respiratory depression can occur.

Pregnancy & Lactation

Flexilax is classified as Pregnancy Category B3. It should only be used during pregnancy if the potential benefits outweigh the possible risks. It is excreted in breast milk in small amounts, which are generally not expected to cause adverse effects in the infant.

Precautions & Warnings

• Use with caution in patients with impaired renal function, psychotic disorders, schizophrenia, epilepsy, or a history of peptic ulcers.
• Monitor respiratory and cardiovascular function, especially in patients with cardiopulmonary disease.
• May cause acute urinary retention in patients with pre-existing sphincter hypertonia.
• Periodically perform laboratory tests for patients with hepatic disease or diabetes.

Overdose Effects

In the case of a severe overdose, gastric lavage is an important management measure.

Therapeutic Class

Flexilax belongs to the class of Centrally acting Skeletal Muscle Relaxants.

Storage Conditions

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