Clobator 5

CLOBATOR 5

CLOBATOR 5 is a medication manufactured by Torrent Pharmaceuticals Ltd.

• Name:

  • Brand Name: Clobator 5
  • Common Name: Clobazam

• Composition:

  • Each tablet contains 5 mg of Clobazam. Clobazam belongs to a class of medicines known as benzodiazepines.

• Uses: CLOBATOR 5 is primarily prescribed for:

  • Treatment of epilepsy (seizures), including Lennox-Gastaut Syndrome. It works by suppressing abnormal and excessive activity of nerve cells in the brain.
  • Short-term treatment of severe anxiety. It can reduce symptoms like restlessness, tiredness, difficulty concentrating, and irritability.
  • It is also used in combination with other medicines to treat schizophrenia.
  • Short-term relief of symptoms associated with alcohol withdrawal syndrome.

• Dosage and Administration:

  • Clobator 5mg Tablet can be taken with or without food.
  • It is advised to take it at the same time each day to maintain a consistent level of medicine in the body.
  • The dose and duration should be as advised by your doctor, as it has a potential for habit formation.
  • Dosage for adults and adolescents over 15 years for anxiety is typically 20-30 mg daily, which may be reduced after symptom improvement. For epilepsy, a starting dose of 20-30 mg/day is recommended, increasing up to a maximum of 60 mg daily as needed.
  • It should not be stopped suddenly without consulting a doctor, as it may increase seizure frequency or cause withdrawal symptoms. If a dose is missed, take it as soon as remembered, but skip if it's almost time for the next dose.

• Side Effects:

  • Common Side Effects: Drowsiness, sleepiness, fatigue, slurred speech, dizziness, dry mouth, constipation, decreased appetite, headache, nausea, irritability, aggression, restlessness, tremors, difficulty in paying attention, depression, cough, drooling, fever.
  • Serious Side Effects: Severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis (especially in the first 8 weeks), suicidal thoughts, increased anxiety, agitation, violent behavior, memory problems (amnesia), hallucinations, new or worsening panic attacks, and increased risk of falling in elderly patients.

• Precautions:

  • Alcohol: Avoid alcohol consumption as it may cause excessive drowsiness and increase other side effects.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy or breastfeeding as it may cause adverse effects in the baby. Consult a doctor.
  • Driving and Machinery: May cause dizziness, sleepiness, double vision, or concentration problems; avoid driving or operating heavy machinery until you know how it affects you.
  • Liver/Kidney Disease: Use with caution in patients with liver or kidney disease; dose adjustment may be required.
  • Drug Dependence: This medicine has the potential to cause drug dependence and abuse, especially with prolonged use. Withdrawal should be gradual under medical supervision.
  • Other: Caution is advised for patients with myasthenia gravis, sleep apnoea, depression, or suicidal tendencies.
  • Drug Interactions: Concomitant use with other CNS depressants (e.g., antipsychotics, hypnotics, opioid analgesics, other anticonvulsants, alcohol) can increase central depressive effects. Inform your doctor about all medications you are taking.

• Storage:

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

CLOBATOR 5 by TORRENT PHARMACEUTICALS LTD. - Frequently Asked Questions

What is Clobator 5 used for?

Clobator 5mg Tablet is primarily used to treat epilepsy (seizures) and severe anxiety. It can also be used as an add-on therapy for a specific type of seizure disorder called Lennox-Gastaut Syndrome (LGS) in patients aged two years and older, and in combination with other medicines for mental illnesses such as schizophrenia.

How does Clobator 5 work?

Clobator 5mg Tablet belongs to a class of medicines called benzodiazepines. It works by increasing the action of a natural chemical messenger in the brain called Gamma-aminobutyric acid (GABA). GABA helps to suppress abnormal and excessive electrical activity of nerve cells in the brain, thereby helping to control seizures, reduce anxiety, and promote a calming effect.

What is the usual dosage of Clobator 5?

The dosage of Clobator 5 varies depending on the condition being treated, the patient's age, and individual response. For adults and adolescents over 15 years, the usual dose for anxiety is typically 20-30 mg daily, which can be taken in divided doses or as a single dose at night. For epilepsy, a starting dose of 20-30 mg/day is recommended, which may be gradually increased up to a maximum of 60 mg daily. For children, the dosage is determined by a doctor based on age, body weight, and disease condition, usually starting with a low dose and gradually increasing. It is generally advised to take Clobator 5 at the same time each day, with or without food, and to swallow the tablet whole.

What are the possible side effects of Clobator 5?

Common side effects of Clobator 5 include drowsiness, fatigue, sleepiness, dizziness, dry mouth, constipation, headache, nausea, decreased appetite, irritability, aggression, restlessness, slurred speech, tremors, and difficulty paying attention. More serious, but rare, side effects can include severe skin reactions (like Stevens-Johnson syndrome), suicidal thoughts, hallucinations, confusion, and memory loss. If any side effects become severe or persistent, it is important to consult your doctor.

Is Clobator 5 safe during pregnancy or breastfeeding?

Clobator 5mg Tablet is generally not recommended during pregnancy (categorized as Category C) as animal studies have shown potential harmful effects on the developing baby, and limited human data also suggests risks. Similarly, it is generally not recommended during breastfeeding because the medicine may pass into breast milk and could cause adverse effects, such as sleepiness, in the baby. Your doctor will assess the potential benefits against the risks before prescribing it during these periods.

Can Clobator 5 be taken with other medications?

Clobator 5mg Tablet can interact with several other medications, which may lead to increased side effects. It can cause enhanced central depressive effects when taken with antipsychotics, hypnotics, other anxiolytics/sedatives, antidepressants, narcotic analgesics (opioids), other anticonvulsant drugs, anesthetics, and sedative antihistamines. Concurrent use with alcohol is not recommended as it can significantly increase drowsiness and other side effects. Combining Clobator 5 with opioids can lead to serious breathing problems, severe drowsiness, coma, and even death, and should be avoided. It may also reduce the effectiveness of hormonal contraceptives. Always inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, you are taking.

What precautions should be taken while taking Clobator 5?

Several precautions should be observed when taking Clobator 5:

• Do not stop suddenly: Abruptly stopping this medication can lead to withdrawal symptoms such as increased seizure frequency, nausea, anxiety, agitation, and flu-like symptoms. The dosage should be gradually reduced under medical supervision.
• Avoid driving and operating machinery: Due to potential side effects like dizziness, drowsiness, blurred vision, or problems with concentration, you should avoid driving or performing tasks that require mental alertness until you know how the medicine affects you.
• Avoid alcohol: Alcohol consumption can increase the sedative effects and other side effects of Clobator 5.
• Habit-forming potential: Clobator 5 has a high potential for habit formation and dependence. It should be taken strictly as prescribed by your doctor.
• Medical conditions: Use with caution if you have kidney or liver disease, depression, or a history of drug or alcohol abuse.
• Mental health monitoring: Monitor for any changes in mood or behavior, including suicidal thoughts, especially during prolonged use, and report them to your doctor immediately.
• Pediatric use: It is not generally recommended for children under 6 years of age, except in exceptional cases as determined by a doctor.

What happens if a dose of Clobator 5 is missed?

If you miss a dose of Clobator 5, 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 the missed one.

How should Clobator 5 be stored?

Clobator 5mg Tablet should be stored at room temperature, below 30°C, away from heat, moisture, and direct light. It should be kept out of the reach and sight of children.