Restobac 10 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Baclofen |
| Company | General pharmaceuticals ltd |
| Also available as |
Indications
- Spasticity resulting from multiple sclerosis
- Flexor spasms and concomitant pain
- 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, preferably with or after food, gradually increased; max. 100 mg daily
- Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose for different age groups
Interaction
- Increased sedation may occur if Restobac is taken with agents acting on the central nervous system, alcohol or synthetic opiates
- Combined treatment with Restobac and antihypertensives is likely to increase the fall in blood pressure
- The concomitant administration of Restobac and tricyclic antidepressants may potentiate the pharmacological effects of Restobac
- In patients with Parkinsons disease receiving treatment with Restobac and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation
- The concurrent use of MAO inhibitors and Restobac may result in increased CNS depressant effects
- Caution should be exercised when administering Restobac 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 and fatigue
- Other side effects including CNS, cardiovascular, gastrointestinal, genitourinary, and other effects
Pregnancy & Lactation
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. 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, Restobac may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued
- Restobac 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
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