Spakem 10 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Baclofen |
| Company | Unimed unihealth 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 GABAB 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
- Treatment for children under 10 years usually starts with 2.5 mg given 4 times daily, then raised according to requirement.
Interaction
- Increased sedation may occur if taken with agents acting on the central nervous system, alcohol or synthetic opiates
- Combined treatment with antihypertensives is likely to increase the fall in blood pressure
- Concomitant administration with tricyclic antidepressants may potentiate the pharmacological effects
- In patients with Parkinson's disease receiving treatment with levodopa and carbidopa, there have been reports of mental confusion, hallucinations, headaches, and agitation
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
- Depression
- Nausea
- Constipation
- Dry mouth
- Rash
- Pruritus
- Visual disturbances
Pregnancy & Lactation
Pregnancy category B3. Safe use during pregnancy has not been established. It crosses the placental barrier. Should only be administered when the potential benefits outweigh the possible hazards. 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
- Treatment for patients suffering from not only spasticity but also psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be closely monitored
- Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of therapy or with overdose
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.