Indications of Fenobac 10 Tablet

Skin infections caused by Staphylococci, Streptococci, Corynebacterium minutissimum, and other Fusidate sensitive organisms are treated with Sodium Fusidate Ointment. Impetigo, boils, abscesses, varicose ulcers, skin grafts, hidradenitis, infected wounds, sycosis barbae, paronychia, folliculitis, carbuncles, and erythrasma are the most common indications.

Pharmacology of Fenobac 10 Tablet

Baclofen inhibits 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 of Fenobac 10 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 Fenobac 10 Tablet

If baclofen is taken with drugs that act on the central nervous system, alcohol, or synthetic opioids, it may increase sedation. It also increases the risk of respiratory depression.

Combination therapy with baclofen and antihypertensive drugs may increase the drop in blood pressure; therefore, the dose of antihypertensive drugs should be adjusted accordingly.

Taking baclofen and tricyclic antidepressants at the same time may enhance the pharmacological effects of baclofen, resulting in significant hypotonia.

In patients with Parkinson’s disease treated with baclofen, levodopa, and carbidopa, there are several reports of confusion, hallucinations, headaches, nausea, and agitation.

Simultaneous use of MAO inhibitors and baclofen may lead to increased CNS inhibition. It is recommended to be cautious, and the dosage of one or two drugs should be adjusted accordingly.

Caution should be exercised when using baclofen and magnesium sulfate or other neuromuscular blockers because in theory there may be a synergistic effect.

Contraindications

Baclofen is contraindicated in patients with hypersensitivity to any component of this product.

Side Effects of Fenobac 10 Tablet

The most common adverse reactions associated with baclofen are brief drowsiness, daytime sedation, dizziness, weakness, and fatigue.

Central nervous system: headache (<10%), insomnia (<10%), rarely euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, coordination disorders, tremor , stiffness, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, dilated pupils, diplopia, dysarthria, seizures, respiratory depression.

Cardiovascular: hypotension (<10%), rare dyspnea, palpitations, chest pain and syncope.

Gastrointestinal tract: Nausea (~ 10%), constipation (<10%), rarely dry mouth, anorexia, dysgeusia, abdominal pain, vomiting, diarrhea, and positive fecal occult blood test.

Urogenital system: frequent urination (<10%), rarely enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Others: abnormally increased rash, itching, ankle swelling, excessive sweating, weight gain, nasal congestion, visual impairment, liver dysfunction, and cramps. The loss of muscle tone may be enough to make walking or exercise difficult, but is usually alleviated by readjusting the dose. For this reason, you can reduce the dose during the day and increase the dose at night.

Pregnancy & Lactation

Pregnancy category B3. 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 judgement 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.

Precautions & Warnings

Patients with kidney failure or undergoing chronic hemodialysis should use a lower dose (approximately 5 mg per day).

Patients with not only seizures, but also mental disorders, schizophrenia, depression, or mania or confusion should be treated with caution and closely monitored because these disorders can worsen.

For patients with epilepsy and muscle spasms, baclofen can be used under proper supervision, provided appropriate anticonvulsant therapy is continued. After stopping baclofen treatment or an overdose, there may be reports of lowered seizure threshold and seizures.

Patients with or with a history of peptic ulcer, cerebrovascular disease, or liver, kidney, or respiratory failure should use baclofen with caution.

Careful monitoring of respiratory and cardiovascular function is essential, especially for patients with cardiopulmonary disease and respiratory muscle weakness.

During treatment with baclofen, neurogenic disorders affecting bladder emptying may improve. However, in patients with pre-existing sphincter hypertonia, acute urinary retention may occur. Baclofen should be used with caution in these situations.

Baclofen has no significant benefit for stroke patients. These patients also have little tolerance for this drug.

Appropriate laboratory tests should be performed on patients with liver disease or diabetes on a regular basis to ensure that drug-induced changes have not occurred under these underlying conditions.

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.

Pharmaceutical Name of Fenobac 10 Tablet

Eskayef Pharmaceuticals Ltd

Generic of Fenobac 10 Tablet

Baclofen