Cloba Mt 5mg Tab

CLOBA MT 5MG Tablet

Name

• Brand Name: CLOBA MT 5MG Tablet
• Common Name: Clobazam

Composition

• Active Ingredient: Clobazam IP 5 mg
  • Clobazam is a 1,5-benzodiazepine with anticonvulsant properties. It works by increasing the action of Gamma-aminobutyric acid (GABA), a chemical messenger in the brain that helps to calm nerves and stabilize electrical activity, thereby preventing seizures and reducing anxiety.

Uses

CLOBA MT 5MG Tablet is primarily used for:

• Epilepsy/Seizures: It is used as an adjunctive therapy to manage seizures in epilepsy patients, including those with Lennox-Gastaut syndrome, especially when current therapy is not adequately stabilizing them.
• Severe Anxiety: Prescribed for the short-term management (2-4 weeks) of severe anxiety, helping to alleviate symptoms like restlessness, worry, difficulty concentrating, and irritability.
• Schizophrenia: It can be used in combination with other medicines to treat schizophrenia (a mental illness).
• Alcohol Withdrawal Syndrome: Also used to relieve short-term symptoms of alcohol withdrawal.

Dosage and Administration

• Take CLOBA MT 5MG Tablet exactly as prescribed by your doctor. It can be taken with or without food, preferably at the same time each day to maintain consistent medicine levels.
• Swallow the tablet whole with a glass of water; do not crush, chew, or break it.
• For Epilepsy:
  • Adults: Initially, 5-15 mg/day, gradually increasing to a maximum daily dose of 80 mg as needed. Doses above 5 mg/day should be administered in two divided doses. Dose escalation should not be more rapid than weekly.
  • Pediatric patients (2 years and above): Starting dose is typically 5 mg for those ≤30 kg body weight and 10 mg for those >30 kg body weight, with gradual increases as directed by a doctor.
• For Anxiety (Adults): Typically 20-30 mg daily in divided doses or as a single dose at night; maximum 60 mg daily.
• Elderly Patients: Require lower initial doses (e.g., 10-20 mg daily) and gradual dose increments under careful observation due to an increased risk of adverse reactions.
• Withdrawal: Do not stop this medicine suddenly, as abrupt discontinuation can lead to severe withdrawal symptoms, including increased seizure frequency, psychosis, and tremors. The dosage should be gradually tapered by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued, as advised by your doctor.

Side Effects

Common Side Effects:

• Drowsiness, sleepiness, fatigue, tiredness
• Dizziness, lightheadedness
• Headache
• Constipation
• Dry mouth
• Nausea, decreased appetite
• Irritability, aggression, restlessness, agitation
• Difficulty concentrating, speech disorder, slurred speech
• Tremors, abnormality of voluntary movements, poor coordination, ataxia

Serious Side Effects (Report to your doctor immediately):

• Severe skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which may start as a rash with fever and flu-like symptoms and progress to blistering and peeling skin.
• Weak or shallow breathing, respiratory depression, or breathing problems, especially when used with opioids or alcohol.
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression.
• Severe drowsiness, confusion, loss of consciousness.
• Allergic reactions (rash, itching, hives, swelling of the face, lips, tongue, or throat).
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a rare but serious hypersensitivity reaction.

Precautions

• Allergies: Inform your doctor if you are allergic to Clobazam or any other benzodiazepines.
• Pregnancy and Breastfeeding: Not recommended during pregnancy or breastfeeding as it may cause adverse effects on the baby.
• Alcohol: Avoid alcohol consumption as it can increase drowsiness, dizziness, and the risk of dangerous side effects, including severe breathing problems and coma.
• Driving and Operating Machinery: Avoid driving or engaging in activities requiring mental alertness if you experience dizziness, double vision, or drowsiness.
• Dependence and Abuse: Clobazam has a high potential for habit-forming, dependence, and abuse, especially with long-term use and higher doses. The duration of treatment is generally kept as short as possible.
• Drug Interactions: Inform your doctor about all medications, vitamins, and supplements you are taking. Concomitant use with other CNS depressants (e.g., opioids, sleep medicines, muscle relaxers, certain antidepressants, antipsychotics) can increase the risk of severe sedation and respiratory depression. Clobazam may also reduce the effectiveness of hormonal contraceptives.
• Pre-existing Medical Conditions: Use with caution in patients with liver disease, kidney disease, respiratory problems (e.g., bronchial asthma, sleep apnea), myasthenia gravis (muscle weakness), depression, suicidal tendencies, or a history of drug/alcohol abuse.
• Elderly Patients: Use with caution due to increased risk of side effects like dizziness, muscle weakness, and drowsiness, which can lead to falls.
• Children: Not recommended for children below 6 years of age for anxiety. For seizures, use in children 2 years and above, with dose adjustments based on weight and under medical supervision.

Storage

• Store in a cool and dry place, protected from sunlight and moisture.
• Keep out of sight and reach of children.
• Store at room temperature, ideally between 10ºC to 25ºC or below 30ºC.

CLOBA MT 5mg Tablet, manufactured by Intas Pharmaceuticals Ltd., contains Clobazam as its active ingredient. It belongs to a class of medicines known as benzodiazepines.

What is CLOBA MT 5mg Tablet used for?

CLOBA MT 5mg Tablet is primarily used to treat epilepsy (fits) and severe anxiety for a short duration. It is also used as an add-on therapy for seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older and can be used in combination with other medicines to treat schizophrenia, a mental illness.

How does CLOBA MT 5mg Tablet work?

CLOBA MT 5mg Tablet works by increasing the activity of Gamma-aminobutyric acid (GABA), a natural chemical messenger in the brain that acts as a nerve-calming agent. By binding to GABA receptors, it helps to stabilize the electrical activity of nerve cells in the brain, thereby preventing fits, reducing anxiety, and inducing sleep.

What is the usual dosage of CLOBA MT 5mg Tablet?

The dosage of CLOBA MT 5mg Tablet is determined by your doctor based on your medical condition. It can be taken with or without food, but it's often advised to take it at the same time each day to maintain a consistent level in the body. The tablet should be swallowed whole with water and not crushed, chewed, or broken. For epilepsy in adults, initial doses are typically 5-15 mg/day, gradually increasing up to a maximum of 80 mg daily, administered in two divided doses for amounts over 5 mg/day. For anxiety in adults, the usual dose is 20-30 mg daily, given in divided doses or as a single dose at night, with a maximum of 60 mg daily.

What are the possible side effects of CLOBA MT 5mg Tablet?

Common side effects include drowsiness, fatigue, dizziness, irritability, constipation, aggressive behavior, tiredness, dry mouth, loss of appetite, nausea, headache, slurred speech, and difficulty in paying attention. More serious, but rare, side effects can include severe skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis, and suicidal thoughts. CLOBA MT 5mg Tablet has a high potential for habit formation, especially with long-term use.

Is CLOBA MT 5mg Tablet safe during pregnancy or breastfeeding?

CLOBA MT 5mg Tablet is generally considered unsafe during pregnancy, particularly in the second and third trimesters, as it may harm the unborn baby. It is also not recommended for use during breastfeeding, as the medicine may be excreted in breast milk and cause adverse effects in the baby. Always consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Can CLOBA MT 5mg Tablet be taken with other medications?

CLOBA MT 5mg Tablet can interact with other medications, so it's crucial to inform your doctor about all medicines you are taking. Concomitant use with opioids is not recommended as it can significantly increase the risk of breathing problems, drowsiness, coma, and even death. Combining it with other central nervous system (CNS) depressants or alcohol can also increase sedation and somnolence. It may also reduce the effectiveness of hormonal contraceptives. Your doctor may need to adjust dosages of CLOBA MT or other medications if they are taken together.

What precautions should be taken while using CLOBA MT 5mg Tablet?

Do not stop taking CLOBA MT 5mg Tablet suddenly without consulting your doctor, as abrupt discontinuation can lead to withdrawal symptoms and potentially increase seizure frequency. Alcohol consumption should be avoided as it can heighten drowsiness and other side effects. Due to potential dizziness and sleepiness, avoid driving or operating heavy machinery until you understand how the medicine affects you. Use with caution if you have liver or kidney problems, myasthenia gravis (muscle weakness), sleep apnea, or other breathing issues. Patients, especially those with a history of substance abuse or depression, should be monitored for signs of habituation, dependence, or suicidal thoughts.

What happens if a dose of CLOBA MT 5mg Tablet is missed?

If you miss a dose of CLOBA MT 5mg Tablet, take it as soon as you remember. However, if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. Missing doses may trigger a seizure.

How should CLOBA MT 5mg Tablet be stored?

CLOBA MT 5mg Tablet should be stored in a cool and dry place, away from direct sunlight. Keep it out of sight and reach of children. The recommended storage temperature is below 30°C or between 10ºC to 25ºC. It should also be protected from light and moisture.