Flexifen 10 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Baclofen |
| Company | Incepta pharmaceuticals ltd |
| Also available as |
Indications
- spasticity resulting from multiple sclerosis
- flexor spasms and concomitant pain, clonus and muscular rigidity
- skeletal muscle spasm resulting from rheumatic disorders
- spinal cord injuries and other spinal cord diseases
- cerebrovascular accidents or neoplastic or degenerative brain disease
Pharmacology
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABA receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
Dosage & Administration
- 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily for adults & children over 10 years
- Treatment for children <10 years usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose as per age
Interaction
- Increased sedation may occur if taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
- Combined treatment with antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
- The concomitant administration of Flexifen and tricyclic antidepressants may potentiate the pharmacological effects resulting in pronounced muscular hypotonia.
- In patients with Parkinson's disease receiving treatment with Flexifen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
- The concurrent use of MAO inhibitors and Flexifen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
- Caution should be exercised when administering Flexifen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Contraindications
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
Side Effects
- Transient drowsiness
- Daytime sedation
- Dizziness
- Weakness
- Fatigue
- Various adverse reactions related to Central Nervous System, Cardiovascular, Gastrointestinal, Genitourinary, and others
Pregnancy & Lactation
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Precautions & Warnings
- Lower doses should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
- Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
- In patients with epilepsy and muscle spasticity, Flexifen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued.
- Flexifen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
- Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
- During treatment with Flexifen, neurogenic disturbances affecting emptying of the bladder may improve.
- Flexifen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
- Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
Overdose Effects
Gastric lavage is important in case of severe overdose.
Therapeutic Class
Centrally acting Skeletal Muscle Relaxants
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.