- Spasticity resulting from multiple sclerosis
- Flexor Spasm and concomitant pain, clonus and muscular rigidity
- Skeletal muscle spasms resulting from rheumatic disorders
- Spinal cord injuries and other spinal cord diseases
- Cerebrovascular accidents or neoplastic or degenerative brain disease
Composition: Zerolent 10 tablet: Each film coated tablet contains Baclofen USP 10 mg.
Therapeutic Class: Skeletal Muscle Relaxant
Generic Name: Baclofen USP
Pharmacology: Baclofen is an effective muscle relaxant and antispastic agent with a spinal site of action. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAg-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. The drug is rapidly absorbed after oral administration and is widely distributed throughout the body. Biotransformation is low: the drug is predominantly excreted unchanged by the kidneys. The half-life of baclofen is roughly 2–4 hours; it therefore needs to be administered frequently throughout the day to control spasticity appropriately.
Dose & Administration:
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; maximum 100 mg daily.
Contraindication: Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
Warning & Precaution: Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness.
a) Common: The most common side-effects include drowsiness, nausea, dizziness,
lassitude, fatigue, abdominal pain, Headache, muscular pain and weakness.
b) Rare: Rare side effects include hypotension.
Use in Pregnancy & Lactation: 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 judgment 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.
Use in children & adolescents: Usual maintenance dose is 0.75 – 2 mg/ kg daily in divided dose. Safety effectiveness in pediatric patients below age of 12 years have not been established.
a) With medicine: Baclofen should not take with CNS depressants, lithium, tricyclic anti-depressant, Ibuprofen etc. Co-administration with those medicines can decrease the excretion rate of Baclofen.
b) With Food and others: Alcohol can increase the nervous system side effects of baclofen such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment Overdose: Gastric lavage is important in case of sever overdose. Storage: Store below 30°C, protected from light & moisture. Keep away from the reach of the children.
Packing: Zerolent 10 tablets: Each box containing 3 X10’s tablets in Alu-PVC blister pack.