Flexifen 10

Indications

Flexifen is prescribed for:

• Spasticity due to multiple sclerosis
• Flexor spasms accompanied by pain, clonus, and muscular rigidity
• Skeletal muscle spasms from rheumatic conditions
• Spinal cord injuries and related diseases
• Effects of cerebrovascular accidents or degenerative brain diseases

Consult a registered healthcare professional before use.

Pharmacology

Baclofen, the active ingredient in Flexifen, inhibits both monosynaptic and polysynaptic reflexes at the spinal level by activating GABAB receptors, which in turn suppresses glutamate and aspartate release. It may also produce central nervous system (CNS) depression at intraspinal sites and offers an antinociceptive effect.

Dosage & Administration

• Adults and children over 10 years: Start with 5 mg three times daily, preferably with or after food, gradually increasing as needed, up to a maximum of 100 mg per day.
• Children under 10 years: Initiate treatment with 2.5 mg (2.5 ml) four times daily, adjusting based on age and weight:
  • 12 months – 2 years: 10-20 mg (10-20 ml)
  • 2 – 6 years: 20-30 mg (20-30 ml)
  • 6 – 10 years: 30-60 mg (30-60 ml)

Consult a registered healthcare professional before use.

Interactions

• CNS Depressants: Increased sedation may occur when taken with other CNS agents, alcohol, or synthetic opiates, raising the risk of respiratory depression.
• Antihypertensives: Concomitant use may enhance blood pressure-lowering effects, necessitating dosage adjustments.
• Antidepressants: Can potentiate effects, leading to increased muscular hypotonia.
• Parkinson’s Treatment: Careful monitoring is required when used with levodopa and carbidopa, as mental confusion and agitation have been reported.
• MAO Inhibitors: May increase CNS depressant effects; dosage adjustments may be needed.
• Neuromuscular Agents: Exercise caution with magnesium sulfate and similar agents due to potential synergistic effects.

Contraindications

Baclofen is contraindicated in individuals with hypersensitivity to any of its components.

Side Effects

Flexifen is generally well tolerated, but common side effects include:

• Drowsiness
• Dizziness
• Weakness
• Fatigue

Other potential side effects may involve various systems, including gastrointestinal discomfort, central nervous system effects, and rare cardiovascular issues.

Pregnancy & Lactation

Pregnancy Category B3: The safety of Baclofen during pregnancy has not been firmly established. It crosses the placental barrier and should only be used if benefits outweigh risks. Baclofen is excreted in breast milk, but the quantities are minimal, likely posing no risk to nursing infants.

Precautions & Warnings

• Use lower doses in patients with renal impairment or those undergoing dialysis.
• Monitor patients with psychiatric disorders closely, as Flexifen may exacerbate symptoms.
• Caution in epilepsy patients as Flexifen may lower the seizure threshold.
• Monitor respiratory and cardiovascular function in those with cardiopulmonary conditions.
• Caution is advised in patients with a history of peptic ulcers or respiratory failure.

Overdose Effects

In cases of severe overdose, gastric lavage is crucial.

Therapeutic Class

Centrally Acting Skeletal Muscle Relaxants

Storage Conditions

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