- Stock: In Stock
- Brand: Square Pharmaceuticals
- Product ID: Baclofen
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| Generic Name | Baclofen |
|---|---|
| Strength | 5 mg |
| Dosage Form | Tablet |
| Manufacturer | Square Pharmaceuticals PLC |
| Therapeutic Class | Centrally acting Skeletal Muscle Relaxants |
| Pack Size | 3 × 10 tablets |
Overview
Flexilax 5mg Tablet contains Baclofen, a centrally acting skeletal muscle relaxant. Baclofen inhibits monosynaptic and polysynaptic reflexes at the spinal level by stimulating GABA-B receptors, which inhibit the release of excitatory neurotransmitters glutamate and aspartate. The 5mg formulation is particularly suitable for initiating therapy and for patients requiring lower doses, such as those with renal impairment. It is indicated for the relief of spasticity resulting from multiple sclerosis, spinal cord injuries, rheumatic disorders, cerebrovascular accidents, and other spinal cord or brain diseases.
Dosage and Administration
Adults and children over 10 years: Start with 5 mg three times daily with or after food, gradually increased according to response. Maintenance dose: 10–25 mg three times daily. Maximum dose: 100 mg daily. Children under 10 years: Start with 2.5 mg four times daily and adjust to requirement. Daily maintenance doses: 12 months–2 years: 10–20 mg; 2–6 years: 20–30 mg; 6–10 years: 30–60 mg. A lower dose should be used in patients with renal impairment.
Interaction
Baclofen may interact with: CNS depressants and alcohol (increased sedation and risk of respiratory depression); antihypertensives (increased hypotensive effect); tricyclic antidepressants (increased muscular hypotonia); MAO inhibitors (increased CNS depressant effects); levodopa and carbidopa (may cause mental confusion, hallucinations, and agitation); magnesium sulphate and other neuromuscular blocking agents (potential synergistic effect).
Contraindications
Flexilax is contraindicated in patients with known hypersensitivity to Baclofen or any component of the formulation.
Side Effects
Most common: transient drowsiness, daytime sedation, dizziness, weakness, and fatigue. CNS: headache, insomnia, confusion, hallucinations, tremor, and ataxia. Cardiovascular: hypotension, palpitation. Gastrointestinal: nausea, constipation, dry mouth. Genitourinary: urinary frequency or retention. Other: rash, ankle oedema, and excessive perspiration. Muscular hypotonia sufficient to impair walking may occur and is usually managed by dosage adjustment.
Pregnancy and Lactation
Pregnancy Category B3. Safe use during pregnancy has not been established. Baclofen crosses the placental barrier and should only be used in pregnancy if the potential benefit outweighs possible risks. Baclofen is excreted in breast milk in small quantities generally considered unlikely to harm the infant. Use with caution in nursing mothers.
Precautions and Warnings
The 5mg formulation is preferred for patients with renal impairment who require lower doses. Use with caution in patients with epilepsy, psychotic disorders, peptic ulcers, or cardiorespiratory disease. Avoid abrupt withdrawal as it may precipitate seizures.
Storage Conditions
Store below 30°C, away from light and moisture. Keep out of reach of children.
Frequently Asked Questions
Q: Why is the 5mg formulation preferred for starting Baclofen therapy?
A: The 5mg tablet allows gradual dose titration from the recommended starting dose, minimizing the risk of side effects such as drowsiness and weakness while establishing the effective maintenance dose.
Q: Is Flexilax 5mg safe for patients with kidney problems?
A: Patients with renal impairment should use lower doses of Baclofen. The 5mg formulation provides the flexibility needed for appropriate dosing in these patients. Always consult a physician.
