Opsonin Pharma Ltd.
Baclofen 10 mg is indicated for the treatment of spasticity, including flexor spasms, associated pain, clonus, muscular rigidity, as well as skeletal muscle spasms resulting from conditions such as multiple sclerosis, rheumatic disorders, spinal cord injuries, other spinal cord diseases, cerebrovascular accidents, neoplastic, or degenerative brain diseases.
Centrally acting Skeletal Muscle Relaxants
Baclofen 10 mg is an effective muscle relaxant and antispastic agent that primarily acts at the spinal level. While its exact mode of action is not fully understood, Baclofen 10 mg works by stimulating GABAB receptors, which inhibits the release of glutamate and aspartate, thereby affecting both monosynaptic and polysynaptic reflexes.
It may also have central nervous system (CNS) depressant effects at intraspinal sites. Notably, Baclofen 10 mg does not impact neuromuscular transmission. Baclofen 10 mg exhibits an antinociceptive (pain-relieving) effect, although its clinical significance remains uncertain.
Baclofen 10 mg should be taken with a small amount of liquid during meals. The dosing regimen for Baclofen 10 mg varies for adults and children.
In adults, it's typically administered in divided doses, preferably three times a day. The aim is to use the lowest effective dose.
For adults, the therapy usually begins with a low dose and is then increased gradually to achieve the best response, typically falling within the range of 30-80 mg daily. Additional increases may be necessary but should generally not exceed a maximum daily dose of 80 mg.
For children, treatment should begin with an extremely low dose, such as 0.3 mg/kg per day, divided into multiple doses. The dose can then be cautiously increased at 1-2 week intervals until it meets the child's specific needs.
The usual maintenance dose for children typically falls within the range of 0.75 to 2 mg/kg of body weight per day.
For children over 10 years of age, a maximum daily dose of 2.5 mg/kg of body weight may be considered.
Increased sedation may occur when Baclofen 10 mg is taken alongside agents that affect the central nervous system, alcohol, or synthetic opiates. This also elevates the risk of respiratory depression. When Baclofen 10 mg is combined with antihypertensives, it's likely to amplify the drop in blood pressure. Adjustments to the antihypertensive medication dosage may be necessary.
Concurrently administering Baclofen 10 mg with tricyclic antidepressants may intensify Baclofen 10 mg's pharmacological effects, leading to pronounced muscular hypotonia. In individuals with Parkinson's disease receiving Baclofen 10 mg along with levodopa and carbidopa, there have been reports of mental confusion, hallucinations, headaches, nausea, and agitation.
When MAO inhibitors and Baclofen 10 mg are used together, it may result in increased CNS depressant effects. Caution is advised, and the dosage of one or both agents should be adjusted accordingly. Care should also be taken when administering Baclofen 10 mg in conjunction with magnesium sulfate or other neuromuscular blocking agents, as there is a theoretical potential for a synergistic effect.
Baclofen 10 mg is contraindicated in patients with hypersensitivity to any component of this product.
The common adverse reactions associated with Baclofen 10 mg include drowsiness, dizziness, weakness, and fatigue.
More serious adverse reactions are less common, but can occur. These include:
Muscular hypotonia, or low muscle tone, can also occur with Baclofen 10 mg. This is usually relieved by adjusting the dosage.
Pregnancy category B3. The safety of using Baclofen 10 mg during pregnancy has not been established, as it can cross the placental barrier. Administration to pregnant women should only occur when the physician concludes that the potential benefits outweigh the possible risks. Baclofen 10 mg is excreted in breast milk, but available evidence suggests that the quantities are so minimal that no adverse effects on the infant are expected.
Lower doses (approximately 5 mg per day) should be considered for patients with impaired renal function or those undergoing chronic hemodialysis. Patients who not only have spasticity but also suffer from psychotic disorders, schizophrenia, depressive or manic disorders, or confusional states should be treated cautiously and closely monitored, as exacerbations of these conditions may occur. In patients with epilepsy and muscle spasticity, Baclofen 10 mg may be used under appropriate supervision, provided that adequate anticonvulsive therapy is continued. It's important to note that lowering the convulsion threshold may occur, and seizures have been reported after the cessation of Baclofen 10 mg therapy or in cases of overdose.
Caution should be exercised in patients with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal, or respiratory failure. Vigilant monitoring of respiratory and cardiovascular function is essential, especially in those with cardiopulmonary disease and respiratory muscle weakness. While Baclofen 10 mg treatment may improve neurogenic disturbances affecting bladder emptying, individuals with preexisting sphincter hypertonia may experience acute retention of urine in these circumstances. It's important to note that Baclofen 10 mg has not significantly benefited patients with stroke, and they have shown poor tolerance to the medication. For individuals with hepatic diseases or diabetes mellitus, appropriate laboratory tests should be conducted periodically to ensure that there are no medication-induced changes in these underlying conditions.
Gastric lavage is important in case of severe overdose.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Centrally acting Skeletal Muscle Relaxants
Baclofen 10 mg inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which in turn inhibits the release of glutamate and aspartate. Additionally, it may act at intraspinal sites, leading to CNS depression. Baclofen 10 mg also demonstrates an antinociceptive effect.
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.