Flexilax 10

Indications of Flexilax 10

Baclofen is prescribed in the following situations:

• 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 of Flexilax 10

Baclofen suppresses monosynaptic and polysynaptic reflexes in the spinal cord by activating GABAB receptors, which block glutamate and aspartate release. It may also cause CNS depression by acting at intraspinal locations. Baclofen has an antinociceptive effect as well.

 

Dosage & Administration

Adults and children over the age of ten years: 5 mg three times a day, ideally with or after food, progressively increased; maximum dose: Every day, take 100 mg.

Children under the age of ten years: Treatment is generally begun with 2.5 mg (2.5 ml) given four times daily, then increased as needed. Maintenance dosage per day-

• 12 month-2 years: 10-20 mg (10-20 ml)
• 2 years-6 years: 20-30 mg (20-30 ml)
• 6 years-10 years: 30-60 mg (30-60 ml)

 

Interaction of Flexilax 10

• Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
• Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
• The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
• In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
• The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
• Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.

 

Contraindications

Baclofen is not recommended for people who are hypersensitive to any of the product's ingredients.

 

Side Effects of Flexilax 10

Transient sleepiness, daytime sedation, dizziness, weakness, and tiredness are the most frequent side effects of Baclofen.

• Headache (ten percent of the time), insomnia (ten percent of the time), and, less commonly, 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, dip.
• Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
• Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
• Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Rashes, pruritus, ankle oedema, excessive sweating, weight gain, nasal congestion, vision abnormalities, hepatic function problems, and paradoxical increase in spasticity are some of the other symptoms. Muscular hypotonia that makes walking or moving difficult might occur, however this is generally alleviated by changing the dose.

 

Pregnancy & Lactation

Baclofen is classified as a pregnancy category B3 because there is no evidence that it is safe to take while pregnant. Baclofen is able to pass through the placental barrier. Baclofen should only be given to pregnant women if the physician believes the potential benefits outweigh the risks. Baclofen is excreted in breast milk, but the amounts are so tiny that no adverse effects on the child are predicted, according to the data thus far.

 

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, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
• Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
• Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
• During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
• Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
• 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.

 

Therapeutic Class

Skeletal Muscle Relaxants with a Central Action.

 

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name of Flexilax 10

Square Pharmaceuticals Ltd

 

Generic of Flexilax 10

Baclofen