Reflexen 10 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Baclofen |
| Company | Nipro jmi pharma 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 B 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 for adults & children over 10 years
- 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.
Interaction
- Increased sedation may occur if Reflexen is taken with agents acting on the central nervous system, alcohol or synthetic opiates.
- Combined treatment with Reflexen and antihypertensives is likely to increase the fall in blood pressure.
- The concomitant administration of Reflexen and tricyclic antidepressants may potentiate the pharmacological effects of Reflexen resulting in pronounced muscular hypotonia.
Contraindications
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
Side Effects
- transient drowsiness
- daytime sedation
- dizziness
- weakness
- fatigue
- Headache (<10%)
- insomnia (<10%)
- rarely, euphoria
- excitement
- depression
- confusion
- hallucinations
- paraesthesia
- nightmares
- muscle pain
- tinnitus
- slurred speech
- co-ordination disorder
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 (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
- Patients suffering from spasticity and psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously.
- Reflexen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
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.