Frisium 20

FRISIUM 20 (Clobazam 20 mg) by SANOFI INDIA LTD

FRISIUM 20 is a prescription medicine used primarily for its anxiolytic (anxiety-reducing) and anticonvulsant properties. It belongs to a class of medications called benzodiazepines.

• Name:

  • Brand Name: Frisium 20 mg Tablet
  • Common Name: Clobazam

• Composition:

  • Active Ingredient: Clobazam 20 mg

• Uses: FRISIUM 20 is prescribed for the management of various medical conditions:

  • Epilepsy (Seizures): Used to control seizures, including those associated with Lennox-Gastaut syndrome. It stabilizes the electrical activity of nerve cells in the brain.
  • Severe Anxiety: For short-term management of severe anxiety.
  • Schizophrenia: Used in combination with other medicines to treat schizophrenia (a mental illness).
  • Muscle Relaxation: Provides muscle relaxation, useful for treating muscle spasms and discomfort.
  • Sleep Disturbances: Short-term relief of sleep disturbances associated with anxiety.
  • Alcohol Withdrawal Syndrome: To relieve short-term symptoms of alcohol withdrawal.

• Dosage and Administration:

  • Swallow the tablet whole with a glass of water; do not crush, chew, or break it.
  • It can be taken with or without food, but it is advisable to take it at the same time each day to maintain consistent medicine levels.
  • Adults: Typical initial dose is 20-30 mg daily, taken in divided doses or as a single dose at night. The dose may be increased up to a maximum of 60 mg per day as advised by a doctor.
  • Children (over 6 years): The usual dose is 5 mg daily, which may be gradually increased. For children aged 3-12 years, the dose may start at 125 mcg/kg twice daily, increasing every 5 days, with a usual maintenance dose of 250 mcg/kg twice daily, up to a maximum of 500 mcg/kg twice daily.
  • Elderly Patients: A lower dose of 10-20 mg daily is generally recommended.
  • Dosage adjustments may be necessary for patients with impaired liver or kidney function.
  • It is crucial not to stop this medicine abruptly, as sudden discontinuation can lead to withdrawal symptoms, including an increase in seizure frequency. The dose should be tapered off gradually under medical supervision.

• Side Effects:

  • Common Side Effects: Drowsiness, sleepiness, fatigue, tiredness, dizziness, restlessness, irritability, aggressive behavior, headache, dry mouth, constipation, decreased appetite, nausea, upper respiratory infections, difficulty speaking, tremor, unsteadiness, muscle weakness, blurred vision, weight gain, and a "hangover" feeling in the morning.
  • Serious Side Effects: Can include severe skin reactions (like Stevens-Johnson syndrome), suicidal thoughts or behavior, hallucinations, delusions, severe sleep disturbances, dependence, severe blistering, and breathing difficulties (respiratory depression). Overdose symptoms may involve confusion, extreme drowsiness or weakness, loss of consciousness, and slowed breathing.

• Precautions:

  • Allergies: Contraindicated in individuals with a known allergy to Clobazam or other benzodiazepines.
  • Pregnancy: Not recommended during pregnancy due to potential risks to the fetus, including cleft lip and palate or "floppy infant syndrome."
  • Breastfeeding: Avoid during breastfeeding as Clobazam can pass into breast milk and cause adverse effects like drowsiness and feeding difficulties in the infant.
  • Alcohol Consumption: Alcohol should be strictly avoided as it can significantly increase side effects such as drowsiness, sedation, and respiratory depression.
  • Driving and Operating Machinery: Due to the potential for dizziness, drowsiness, and impaired alertness, patients should avoid driving or operating heavy machinery until they understand how the medicine affects them.
  • Liver and Kidney Impairment: Use with caution in patients with liver or kidney problems; regular monitoring of liver and kidney function is necessary, and dose adjustments may be required. Not recommended for severe liver disorders.
  • Elderly Patients: Elderly patients may be more sensitive to adverse reactions such as dizziness, muscle weakness, and drowsiness, necessitating lower initial doses.
  • Respiratory Conditions: Use with caution or avoid in patients with breathing disorders, sleep apnea, or other respiratory problems, as it can suppress breathing.
  • Myasthenia Gravis: Contraindicated in patients with myasthenia gravis due to the increased risk of muscle weakness.
  • Depression and Psychiatric Disorders: Use with caution in patients with depression or other psychiatric disorders, and monitor closely for changes in behavior, mood, or suicidal thoughts.
  • Dependence and Withdrawal: FRISIUM 20 has a high potential for dependence. Long-term use can lead to physical and psychological dependence. Abrupt discontinuation can result in severe withdrawal symptoms.
  • Drug Interactions: Inform your doctor about all other medications being taken, especially other epilepsy medicines (e.g., phenytoin, carbamazepine), antidepressants, antipsychotics, and opioids, as concomitant use can lead to increased sedation, respiratory depression, coma, or death.
  • Pediatric Use: Not generally recommended for children under 6 years for anxiety, but can be used in children over 2 years for certain seizure types under strict medical assessment.

• Storage:

  • Store in a cool and dry place, away from direct sunlight.
  • Keep out of sight and reach of children.
  • Store below 30°C.

Frequently Asked Questions about FRISIUM 20

What is FRISIUM 20 used for?

FRISIUM 20 (Clobazam) is a benzodiazepine medicine primarily used to control seizures in adults and children over 2 years of age, often as an adjunctive therapy for epilepsy. It is also prescribed for the short-term management of severe anxiety and can be used in combination with other medications to treat schizophrenia. Additionally, it may be used for short-term relief of sleep disturbances associated with anxiety and to provide muscle relaxation for muscle spasms, as well as to relieve short-term symptoms of alcohol withdrawal syndrome.

How does FRISIUM 20 work?

FRISIUM 20, containing the active ingredient Clobazam, works by enhancing the action of gamma-aminobutyric acid (GABA), a natural chemical messenger in the brain. GABA is an inhibitory neurotransmitter that helps calm nerve cells. By increasing GABA's effects, FRISIUM 20 suppresses abnormal and excessive electrical activity in the brain, which helps to prevent seizures, reduce anxiety, and promote sleep.

What is the usual dosage for FRISIUM 20?

The dosage of FRISIUM 20 is determined by your doctor and should be started at a small dose, gradually increasing as needed. For adults, the typical daily dose is 20-30 mg, which can be taken as divided doses or as a single dose at night; the maximum daily dose is generally 60 mg. Children over 3 years of age and elderly patients usually receive half the adult dose. FRISIUM 20 can be taken with or without food, but it is advised to take it at the same time each day to maintain consistent medicine levels.

What are the possible side effects of FRISIUM 20?

Common side effects of FRISIUM 20 can include drowsiness, sleepiness, dizziness, fatigue, tiredness, restlessness, irritability, constipation, dry mouth, headache, nausea, decreased appetite, aggression, and upper respiratory infections. More serious, but less common, side effects may include severe skin reactions (like Stevens-Johnson syndrome), suicidal thoughts or behavior, severe sleep disturbances, hallucinations, or delusions. Blurred vision or double vision may also occur. If you experience severe or persistent side effects, contact your doctor.

Is FRISIUM 20 safe during pregnancy or breastfeeding?

FRISIUM 20 is generally not recommended for use during pregnancy as it may cause adverse effects on the baby, including "floppy infant syndrome" (characterized by respiratory depression, hypotonia, and feeding difficulties), and there is a suggested increased risk of miscarriage. Similarly, it is not recommended for use by breastfeeding mothers because the active ingredient passes into breast milk and can cause drowsiness or feeding difficulties in the infant. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can FRISIUM 20 be taken with other medications?

Taking FRISIUM 20 with certain other medications can lead to interactions. It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, herbal remedies, and supplements.

• Opioids and Alcohol: Concomitant use with opioids significantly increases the risk of severe drowsiness, breathing difficulties, coma, and even death. Alcohol consumption should be avoided as it can heighten side effects such as dizziness and excessive drowsiness.
• Other CNS Depressants: Medications that also cause central nervous system depression, such as other sleeping pills, sedatives, some antidepressants, antipsychotics, antihistamines, and muscle relaxants, can increase the sedative effects of FRISIUM 20.
• Epilepsy Medications: Interactions can occur with other anti-epileptic drugs like phenytoin, carbamazepine, stiripentol, or valproic acid.
• Other Medications: Products containing cannabidiol, certain medications for reflux (e.g., omeprazole, cimetidine), antiplatelet medications (e.g., ticlopidine), antifungals (e.g., fluconazole), and some cough suppressants (e.g., dextromethorphan) may also interact.

What precautions should be taken while using FRISIUM 20?

• Driving and Operating Machinery: FRISIUM 20 can cause drowsiness, dizziness, or blurred vision, which may impair your ability to drive or operate heavy machinery. It is advised to avoid these activities until you understand how the medication affects you.
• Abrupt Discontinuation: Do not stop taking FRISIUM 20 suddenly, even if you feel better. Abrupt discontinuation can lead to withdrawal symptoms such as increased seizure frequency, anxiety, tremors, nausea, and confusion. Your doctor will gradually reduce the dose over time.
• Dependence and Abuse: FRISIUM 20 has a high potential for drug dependence and abuse, especially with prolonged use. Your doctor will monitor you closely for any changes in mood or behavior.
• Medical Conditions: Inform your doctor if you have liver, kidney, or lung disease, myasthenia gravis (muscle weakness), sleep apnea, or a history of depression or suicidal thoughts, as these conditions may require special precautions or dose adjustments.
• Elderly Patients: Elderly individuals may be more sensitive to the side effects of FRISIUM 20, such as dizziness, muscle weakness, and drowsiness, and may require lower initial doses.

What happens if a dose of FRISIUM 20 is missed?

If you miss a dose of FRISIUM 20, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet, as this can increase the risk of side effects.

How should FRISIUM 20 be stored?

FRISIUM 20 should be stored in a cool and dry place, away from direct sunlight. It should be kept out of the sight and reach of children. The medicine should be stored below 30°C.