Felo 5 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Baclofen |
| Company | Albion laboratories limited |
| 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
- Adult & children over 10 years: 5 mg 3 times daily, gradually increased; max. 100 mg daily
- Children <10 years: Treatment is usually started with 2.5 mg 4 times daily, raised according to requirement. Daily maintenance dose-12 month-2 years: 10-20 mg, 2 years-6 years: 20-30 mg, 6 years-10 years: 30-60 mg
Interaction
- Increased sedation may occur if Felo is taken with agents acting on the central nervous system, alcohol or synthetic opiates.
- Combined treatment with Felo and antihypertensives is likely to increase the fall in blood pressure.
- The concomitant administration of Felo and tricyclic antidepressants may potentiate the pharmacological effects of Felo.
- In patients with Parkinsons disease receiving treatment with Felo and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
- The concurrent use of MAO inhibitors and Felo may result in increased CNS depressant effects.
- Caution should be exercised when administering Felo and magnesium sulphate or other neuromuscular blocking agents.
Contraindications
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
Side Effects
- Central Nervous System:
- Headache (<10%)
- Insomnia (<10%)
- Rarely euphoria, excitement, depression, confusion, hallucinations
- Cardiovascular: Hypotension (<10%)
- Gastrointestinal: Nausea (approximately 10%), constipation (<10%)
- Genitourinary: Urinary frequency (<10%)
- Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain
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 should be treated cautiously and closely monitored.
- Felo should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
- 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.