
Flexifen5 mg
Incepta Pharmaceuticals Ltd.
Muscle Spasticity in Multiple Sclerosis Baclofen is established (FDA-approved) for the management of spasticity resulting from multiple sclerosis, particularly for relief of flexor spasms and more.
Baclofen is established (FDA-approved) for the management of spasticity resulting from multiple sclerosis, particularly for relief of flexor spasms, associated pain, clonus, and muscular rigidity.
Baclofen is established for the management of spasticity due to spinal cord injuries or spinal cord disease.
Baclofen may also be used, under medical supervision, for spasticity from other central nervous system causes (such as cerebral palsy) as a guideline-supported or commonly used off-label option, although its efficacy for stroke, cerebral palsy, and Parkinson's disease has not been definitively established in controlled trials.
Baclofen is not indicated for the treatment of skeletal muscle spasm resulting from rheumatic disorders (e.g., simple back strain); other agents are preferred for that purpose.
Baclofen dosing is individualized and started low, then increased gradually to the lowest dose that provides adequate relief of spasticity with tolerable side effects. Regimens differ for adults, children, and patients with renal impairment; see the table below and the Pediatric Uses and Use in Special Populations sections for details.
| Population / Situation | Typical Regimen |
|---|---|
| Adults - initial titration | 5 mg by mouth three times daily for 3 days, then increased by 5 mg per dose every 3 days as needed and tolerated |
| Adults - usual maintenance/maximum | Optimal effect is usually seen at 40-80 mg per day in divided doses; maximum recommended dose is 80 mg per day (20 mg four times daily), though some patients may require higher doses under specialist supervision |
| Children (spasticity, specialist-guided use) | Safety and efficacy of Baclofen in children under 12 years have not been established for the oral tablet; when used, pediatric dosing is individualized and weight/age-based under specialist supervision (see Pediatric Uses) |
| Renal impairment | Use with caution and reduce the dose, since Baclofen is eliminated mainly by the kidneys and can accumulate (see Use in Special Populations) |
| Discontinuation | Reduce the dose gradually over at least 1-2 weeks (or longer) whenever Baclofen is being stopped; never stop abruptly except in a medical emergency (see Precautions and Warnings) |
Baclofen is contraindicated only in patients with known hypersensitivity to Baclofen or any component of the formulation.
Disclaimer
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