Backtone 10 gm

Indications of Backtone Tablet

Baclofen is prescribed in :

• Multiple sclerosis-related spasticity
• flexor spasms and discomfort, clonus, and muscle stiffness
• skeletal muscle spasm caused by rheumatic diseases
• spinal cord injuries and various illnesses of the spinal cord
• Cerebrovascular events, as well as neoplastic or degenerative brain illness

 

Pharmacology of Backtone Tablet

Baclofen suppresses both monosynaptic and polysynaptic reflexes in the spinal cord by activating GABAB receptors, which decrease glutamate and aspartate release. It may also have an effect at intraspinal locations, causing CNS depression. Baclofen also has antinociceptive properties.

 

Dosage & Administration of Backtone Tablet

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 is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-

• 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 Backtone Tablet

• Baclofen may cause increased sedation if used with central nervous system depressants, alcohol, or synthetic opiates. There is also an increased risk of respiratory depression.
• Combining Baclofen with antihypertensives is likely to exacerbate blood pressure drop; thus, antihypertensive drug dose should be adjusted correspondingly.
• Baclofen and tricyclic antidepressants used together may increase the pharmacological effects of Baclofen, resulting in severe muscular hypotonia.
• There have been many instances of mental disorientation, hallucinations, headaches, nausea, and agitation in Parkinson's disease patients undergoing therapy with Baclofen, levodopa, and carbidopa.
• The combination of MAO inhibitors with Baclofen at the same time may result in enhanced CNS depressive effects. Caution is advised, and one or both drugs' dosages should be modified accordingly.
• When giving Baclofen with magnesium sulphate or other neuromuscular blocking medications, use caution since a synergistic effect may develop.

 

Contraindications

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

 

Side Effects of Backtone Tablet

Transient sleepiness, daytime sedation, dizziness, weakness, and exhaustion are the most prevalent 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%), dyspnoea, palpitation, chest discomfort, and syncope are all unusual occurrences.

Cardiovascular: Hypotension (10%), dyspnoea, palpitation, chest discomfort, and syncope are all unusual occurrences. Nausea (about 10%), constipation (around 10%), and, less commonly, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea, and a positive test for occult blood in stool.

Urine: Enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, and haematuria are all common genitourinary problems.

Urine: Enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, and haematuria are all common genitourinary problems. Rashes, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, vision disturbances, hepatic function disorders, and paradoxical increase in spasticity are some of the other symptoms. Muscular hypotonia that makes walking or moving difficult can occur, however this is usually alleviated by modifying the dosage. The daytime dosage may be reduced and the evening dosage raised for this purpose.

 

Pregnancy & Lactation

Baclofen is not safe to use during pregnancy, according to pregnancy category B3. Baclofen passes across the placental barrier. Baclofen should only be given to pregnant women if the physician believes that the potential benefits exceed the potential risks. Baclofen is excreted in breast milk, however the research thus far shows that the amounts are so tiny that no adverse effects on the child are predicted.

 

Precautions & Warnings

• Patients with poor renal function or those undergoing chronic haemodialysis should get lower dosages (about 5 mg per day).
• Patients suffering from spasticity, as well as psychotic disorders, schizophrenia, depressive or manic disorders, or confusional states, should be treated with caution and constantly watched, since exacerbations of these diseases are possible.
• Baclofen may be administered in individuals with epilepsy and muscular spasticity under appropriate monitoring and as long as effective anticonvulsive treatment is continued. Seizures have been observed following the discontinuation of Baclofen treatment or in the event of an overdose.
• Baclofen should be used with caution in patients who have peptic ulcers, cerebrovascular disorders, or hepatic, renal, or respiratory failure, or who have a history of these conditions.
• It is critical to carefully evaluate respiratory and cardiovascular function, especially in individuals with cardiopulmonary illness and respiratory muscle weakness.
• Neurogenic abnormalities influencing bladder emptying may improve when using Baclofen. Acute urinary retention may develop in people with preexisting sphincter hypertonia. In these cases, Baclofen should be taken with caution.
• Baclofen has not been shown to assist stroke victims significantly. These individuals have also demonstrated low tolerance to the medication.
• Appropriate laboratory tests should be conducted on a regular basis in patients with hepatic disorders or diabetes mellitus to ensure that no changes in these underlying conditions have been caused by the medication.

 

Therapeutic Class

Centrally acting Skeletal Muscle Relaxants

 

Storage Conditions

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

 

Pharmaceutical Name of Backtone Tablet

Pharmacil Limited

 

Generic of Backtone Tablet

Baclofen