Beklo Oral Solution 100ml

Pharmacology:

Baclofen reduces both monosynaptic and polysynaptic reflexes at the spinal level by activating GABAB receptors, which decreases the release of glutamate and aspartate. It may also act within the spinal cord to cause CNS depression and provide an antinociceptive effect.

Use in Pediatrics:

Beklo is suitable for children and adolescents under 18 if prescribed. Not for use in children weighing below 33 kg. Consult a doctor for guidance.

Use in Geriatrics:

Use with caution in elderly patients.

Overdose Effects:

Severe overdose requires gastric lavage. Symptoms include drowsiness, respiratory difficulties, fainting, muscle weakness, confusion, hallucinations, seizures, low blood pressure, slow heartbeat, nausea, vomiting, diarrhea, excessive salivation, and reflex problems.

Dosage & Administration:

• Adults and children over 10 years: Start with 5 mg three times daily, preferably with or after food, gradually increasing as needed; maximum 100 mg per day.
• Children under 10 years: Start with 2.5 mg (2.5 ml) four times daily, increasing as needed. Maintenance doses are:
  • 12 months to 2 years: 10-20 mg (10-20 ml) daily
  • 2 to 6 years: 20-30 mg (20-30 ml) daily
  • 6 to 10 years: 30-60 mg (30-60 ml) daily
  • Consult a physician for proper dosing.

Interactions:

• Increased sedation when taken with CNS depressants, alcohol, or synthetic opiates.
• Risk of respiratory depression.
• Combining with antihypertensives can cause a significant drop in blood pressure; adjust antihypertensive dosages as needed.
• Concomitant use with tricyclic antidepressants can enhance Baclofen's effects, leading to significant muscle hypotonia.
• Reports of mental confusion, hallucinations, headaches, nausea, and agitation in Parkinson's patients using Baclofen with levodopa and carbidopa.
• Caution with MAO inhibitors due to increased CNS depressant effects; adjust dosages accordingly.
• Caution with magnesium sulfate or neuromuscular blocking agents due to potential synergistic effects.

Contraindications:

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

Side Effects:

Common side effects include transient drowsiness, daytime sedation, dizziness, weakness, and fatigue. Less common effects involve:

• CNS: Headache, insomnia, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, coordination disorders, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, seizures, respiratory depression.
• Cardiovascular: Hypotension, dyspnoea, palpitations, chest pain, syncope.
• Gastrointestinal: Nausea, constipation, dry mouth, anorexia, taste disorders, abdominal pain, vomiting, diarrhea, positive occult blood test.
• Genitourinary: Urinary frequency, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
• Others: Rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders, increased spasticity. Severe hypotonia may be alleviated by dose adjustment.

Pregnancy & Lactation:

Pregnancy category B3. Baclofen's safety in pregnancy is unestablished and it crosses the placental barrier. Use only if benefits outweigh risks. Baclofen is excreted in breast milk, but quantities are minimal and likely safe for infants.

Precautions & Warnings:

• Use lower doses (approx. 5 mg/day) for patients with impaired renal function or on chronic hemodialysis.
• Caution in patients with spasticity and psychotic disorders, schizophrenia, depressive or manic disorders, or confusion, as exacerbations may occur.
• Use under supervision in patients with epilepsy and muscle spasticity.
• Caution in patients with a history of peptic ulcers, cerebrovascular diseases, hepatic, renal, or respiratory failure.
• Monitor respiratory and cardiovascular function in patients with cardiopulmonary disease and respiratory muscle weakness.
• May improve neurogenic bladder disturbances but can cause acute urinary retention in patients with preexisting sphincter hypertonia.
• Not significantly beneficial for stroke patients, who may poorly tolerate the medication.
• Periodic laboratory tests for hepatic diseases or diabetes mellitus are recommended to monitor for medication-induced changes.

Storage Conditions:

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