Reflexen 25 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
- skeletal muscle spasm resulting from rheumatic disorders
- spinal cord injuries and other spinal cord diseases
- cerebrovascular accidents
- 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
- Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement for children under 10 years
Interaction
- Increased sedation may occur if Reflexen is taken with agents acting on the central nervous system
- 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
- In patients with Parkinsons disease receiving treatment with Reflexen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation
- The concurrent use of MAO inhibitors and Reflexen may result in increased CNS depressant effects
- Caution should be exercised when administering Reflexen 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
- Headache
- insomnia
- euphoria
- excitement
- depression
- confusion
- hallucinations
- paraesthesia
- nightmares
- muscle pain
- tinnitus
- slurred speech
- co-ordination disorder
- tremor
- rigidity
- dystonia
- ataxia
- blurred vision
- nystagmus
- strabismus
- miosis
- mydriasis
- diplopia
- dysarthria
- epileptic seizures
- respiratory depression
- Hypotension
- dyspnoea
- palpitation
- chest pain
- syncope
- Nausea
- constipation
- dry mouth
- anorexia
- taste disorder
- abdominal pain
- vomiting
- diarrhoea
- positive test for occult blood in stool
- Urinary frequency
- enuresis
- urinary retention
- dysuria
- impotence
- inability to ejaculate
- nocturia
- haematuria
- rash
- pruritus
- ankle oedema
- excessive perspiration
- weight gain
- nasal congestion
- visual disturbances
- hepatic function disorders
- paradoxical increase in spasticity
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; 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 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, Reflexen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued
- Reflexen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure
- During treatment with Reflexen, neurogenic disturbances affecting emptying of the bladder may improve
- Reflexen has not significantly benefited patients with stroke
- 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.