Spakem 5 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 GABA and 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 usually started with 2.5 mg given 4 times daily then raised according to requirement.
Interaction
- Increased sedation may occur if Spakem is taken with agents acting on the central nervous system, alcohol or synthetic opiates
- The risk of respiratory depression is also increased with combined treatment with antihypertensives
- The concomitant administration of Spakem and tricyclic antidepressants may potentiate the pharmacological effects of Spakem resulting in pronounced muscular hypotonia
- In patients with Parkinsons disease receiving treatment with Spakem and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation
- The concurrent use of MAO inhibitors and Spakem may result in increased CNS depressant effects
- Caution should be exercised when administering Spakem and magnesium sulfate 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
- Nausea
- Constipation
- Dry mouth
- Anorexia
- Taste disorder
- Abdominal pain
- Vomiting
- Diarrhea
- Genitourinary
- Urinary frequency
Pregnancy & Lactation
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established.
Precautions & Warnings
- Lower doses should be used for patients with impaired renal function or those undergoing chronic hemodialysis
- Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously
- Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Spakem therapy or with overdose
- Spakem 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 Spakem, neurogenic disturbances affecting emptying of the bladder may improve
- Spakem 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.