Cloba 20

CLOBA 20 by INTAS PHARMACEUTICALS LTD

Name

• Common Name: Clobazam
• Brand Name: CLOBA 20

Composition

• Active Ingredient: Clobazam 20mg

Uses

CLOBA 20 is primarily prescribed for the management of various neurological and psychiatric conditions.

• Epilepsy/Seizures: It is used to help control seizures (convulsions) in patients with epilepsy, including those with Lennox-Gastaut syndrome (LGS). It works by stabilizing the electrical activity of nerve cells in the brain by increasing the action of GABA, a chemical messenger that calms nerve cells.
• Severe Anxiety: It is used for the short-term treatment of severe anxiety by reducing symptoms of excessive worry, restlessness, fatigue, and irritability.
• Schizophrenia: It can be used in combination with other medicines to treat schizophrenia.
• Alcohol Withdrawal Syndrome: It may also be used to relieve the short-term symptoms of alcohol withdrawal syndrome.

Dosage and Administration

CLOBA 20 is an oral medication that can be taken with or without food, ideally at the same time each day to maintain consistent medicine levels. The dosage is individualized by a doctor based on medical condition, age, and body weight.

• Adults and Children (2 years and older weighing >30 kg): A typical starting dose is 10 mg per day, given as two divided doses. The dose may be adjusted up to a maximum of 40 mg per day.
• Adults and Children (2 years and older weighing ≤30 kg): The usual starting dose is 5 mg as a single daily dose, adjustable up to a maximum of 20 mg per day.
• Elderly Patients, Patients with Hepatic Impairment, or CYP2C19 Poor Metabolizers: A lower starting dose (e.g., 5 mg/day) and slower titration may be required, with maximum doses potentially halved.
• Important Note: Do not stop taking this medicine abruptly, as it may lead to withdrawal symptoms such as convulsions, behavioral disorders, tremors, and anxiety. Gradual reduction under medical supervision is necessary.

Side Effects

• Common Side Effects: Drowsiness, fatigue, difficulty staying awake or alert, dizziness, upper respiratory infections, agitation, irritability, aggressive behavior, depression, headache, dry mouth, constipation, loss of appetite, nausea, slurred speech, unsteadiness, and tremors.
• Serious Side Effects (Seek immediate medical attention if experienced): Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), suicidal thoughts or behavior changes, confusion, hallucinations, worsening depression, unusual excitement, nervousness, severe dizziness, extreme weakness, or breathing problems.

Precautions

• Pregnancy and Breastfeeding: Not recommended during pregnancy as it may cause problems in the newborn (e.g., sedation, withdrawal symptoms, cleft lip/palate risk). It may pass into breast milk and cause adverse effects in the baby, so breastfeeding is generally not advised. Consult your doctor.
• Alcohol Consumption: Avoid alcohol as it can increase drowsiness and other side effects.
• Driving and Operating Machinery: This medicine can cause dizziness, drowsiness, and blurred vision. Avoid activities requiring mental alertness, such as driving or operating heavy machinery, until you know how it affects you.
• Pre-existing Conditions: Use with caution in patients with liver or kidney diseases, depression, lung or breathing problems (e.g., sleep apnea), or myasthenia gravis. Close monitoring and dose adjustments may be necessary.
• Drug Interactions: Inform your doctor about all medicines you are taking. CLOBA 20 can interact with other CNS depressants (e.g., antihistamines, sedatives, narcotics, other seizure medications), certain antidepressants, and antipsychotics. Birth control pills may become less effective.
• Dependence and Abuse: CLOBA 20 has the potential for drug dependence and abuse, especially with prolonged use. It is crucial to follow your doctor's instructions and not to stop the medication suddenly.
• Pediatric Use: Not recommended for children below 2 years of age (some sources state below 6 years).

Storage

Store CLOBA 20 tablets in a cool, dry place away from direct sunlight, typically below 25°C or 30°C. Keep the medicine out of sight and reach of children. Oral suspension formulations should be stored upright in their original bottle and protected from light.

CLOBA 20 is a medication manufactured by Intas Pharmaceuticals Ltd., with the active ingredient Clobazam. It is a benzodiazepine primarily used for its anticonvulsant and anxiolytic properties.

What is CLOBA 20 used for?

CLOBA 20 (Clobazam) is primarily used as an add-on treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years and older. It is also prescribed for the short-term management of severe anxiety and tension.

How does CLOBA 20 work?

CLOBA 20 works by enhancing the activity of gamma-aminobutyric acid (GABA), a natural inhibitory neurotransmitter in the brain. By binding to specific sites on GABA-A receptors, Clobazam increases the frequency of chloride channel opening, which leads to hyperpolarization and stabilization of neuronal membranes, thereby decreasing abnormal electrical activity and calming nerve cells in the brain.

What is the usual dosage for CLOBA 20?

The dosage of CLOBA 20 varies depending on the patient's age, weight, and the condition being treated. For adults and adolescents over 12 years, the initial dose is typically 10 to 20 mg per day, given in one or two divided doses, and may be adjusted up to 40 mg per day. For children aged 2 years and older, dosing is weight-based, usually starting at 5 mg per day and gradually increased as directed by a doctor, typically not exceeding 20 mg per day for those weighing 30 kg or less, and up to 40 mg per day for those over 30 kg. The dose is usually increased slowly, often once a week, and should not be stopped suddenly.

What are the possible side effects of CLOBA 20?

Common side effects of CLOBA 20 can include drowsiness, tiredness, problems with coordination (ataxia), dizziness, headache, nausea, lethargy, aggression, drooling, irritability, constipation, and difficulty speaking or swallowing. More serious side effects, though rare, can include severe skin reactions like Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, respiratory depression, worsening depression, suicidal thoughts or actions, and the potential for dependence and withdrawal symptoms.

Is CLOBA 20 safe during pregnancy or breastfeeding?

Pregnancy: There is not enough evidence to fully assess the developmental risks of Clobazam during pregnancy. However, taking Clobazam during the later stages of pregnancy may cause problems in the newborn, such as sedation or withdrawal symptoms. It is important to discuss with your doctor if you are pregnant or planning to become pregnant, and not to stop seizure medication without medical advice. Breastfeeding: Clobazam and its active metabolite pass into breast milk. Breastfed infants may experience effects such as lethargy, drowsiness, or poor sucking. Your healthcare provider will weigh the potential benefits against the potential risks before recommending Clobazam while breastfeeding.

Can CLOBA 20 be taken with other medications?

CLOBA 20 can interact with other medications, potentially leading to increased side effects. Concomitant use with other central nervous system (CNS) depressants, such as alcohol, opioids (like oxycodone, morphine), sedatives, tranquilizers, or other seizure medicines, can increase the risk of severe drowsiness, breathing problems, coma, and even death. Clobazam may also reduce the effectiveness of hormonal birth control, so additional non-hormonal contraception methods are recommended. It can also interact with certain medications that affect liver enzymes (e.g., fluconazole, omeprazole), requiring dose adjustments.

What precautions should be taken with CLOBA 20?

It is very important that you do not stop taking CLOBA 20 suddenly, as this can lead to withdrawal seizures and other severe withdrawal symptoms. Your doctor will advise you on how to gradually reduce the dose if needed. Use with caution if you have a history of alcohol or drug abuse, depression, lung or breathing problems, or liver problems. You should avoid alcohol while taking this medicine. Close monitoring for any changes in mood, behavior, or the emergence of suicidal thoughts is also important.

What happens if a dose of CLOBA 20 is missed?

If you miss a dose of CLOBA 20, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., within 3-4 hours), skip the missed dose and continue with your regular dosing schedule. Do not double doses to make up for a missed one. If you are unsure or have missed multiple doses, contact your doctor for advice.

How should CLOBA 20 be stored?

CLOBA 20 tablets and oral film should be stored at room temperature, typically between 20°C to 25°C (68°F to 77°F), away from moisture and heat. If using the oral suspension, store it in its original bottle in an upright position and discard any unused portion 90 days after first opening the bottle. Always keep this medicine out of the reach of children.