Cloba Syrup

CLOBA SYRUP

CLOBA SYRUP is a medication manufactured by SANOFI INDIA LTD.

Composition The active ingredient in CLOBA SYRUP is Clobazam. It belongs to a class of medicines known as benzodiazepines.

Uses CLOBA SYRUP is primarily prescribed for the management of:

• Epilepsy (seizures) in adults and children aged over 2 years, often as adjunctive therapy when standard treatments have failed. It helps suppress abnormal and excessive nerve cell activity in the brain.
• Severe anxiety in adults, reducing symptoms like restlessness, tiredness, and difficulty concentrating.
• Short-term management of hyperarousal and agitation in patients with schizophrenic or other psychotic illnesses, used in combination with other treatments.
• Specifically, it's used to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

Dosage and Administration

• CLOBA SYRUP should be taken exactly as prescribed by your doctor, with or without food.
• It is advisable to take it at the same time each day to maintain consistent medicine levels.
• Shake the bottle well before each use.
• Dosage is individualized based on age, body weight, and medical condition, with initial low doses gradually increased by the doctor.
• Do not stop this medicine suddenly, as it can lead to withdrawal symptoms and increased seizure frequency. The dosage must be gradually reduced under medical supervision.

Side Effects Common side effects may include:

• Sleepiness, tiredness, fatigue
• Constipation, dry mouth, nausea, decreased appetite
• Headache, dizziness, confusion
• Irritability, aggression, restlessness, depression
• Difficulty in concentrating, speech disorder, tremors Serious, though less common, side effects include psychotic reactions, suicidal thoughts, respiratory depression, severe skin reactions, and drug dependence.

Precautions

• Alcohol: Avoid alcohol consumption as it may increase drowsiness and other side effects.
• Pregnancy: Not recommended during pregnancy due to potential risks to the fetus, including cleft lip and palate. Consult your doctor if pregnant or planning pregnancy.
• Breastfeeding: Probably unsafe during breastfeeding as it may pass into breast milk. Consult your doctor.
• Driving/Operating Machinery: Avoid activities requiring mental alertness if you experience sleepiness, dizziness, or impaired concentration.
• Kidney/Liver Disease: Use with caution; dose adjustments may be necessary.
• Habit-forming potential: This medicine has a high potential for habit formation; strictly adhere to the prescribed dose and duration.
• Drug Interactions: Inform your doctor about all other medications, including herbal supplements, as interactions can occur, such as reduced effectiveness of hormonal birth control.
• Children: Not recommended for children under 2 years of age unless absolutely necessary.
• Elderly: Use with caution in patients over 65 due to increased sensitivity to side effects.

Storage

• Store below 25°C or at room temperature between 20°C to 25°C (68°F to 77°F).
• Keep out of sight and reach of children.
• Store in its original bottle in an upright position.
• Use within 90 days of first opening the bottle; discard any unused medicine after this period.

CLOBA Syrup contains Clobazam as its active ingredient and is a benzodiazepine medication. It is primarily used to manage certain types of seizures and severe anxiety.

What is CLOBA Syrup used for?

CLOBA Syrup 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 used for the short-term management of symptoms of severe anxiety in adults.

How does CLOBA Syrup work?

CLOBA Syrup works by enhancing the action of Gamma-Aminobutyric Acid (GABA), a natural chemical messenger in the brain. This increased GABA activity helps to suppress abnormal and excessive nerve cell activity, which in turn calms the brain, reduces seizure frequency, and alleviates anxiety symptoms.

What is the usual dosage of CLOBA Syrup?

The dosage of CLOBA Syrup is determined by your doctor, based on your age and body weight. For adults and children weighing more than 30 kilograms (kg), the starting dose is usually 10 milligrams (mg) per day, divided into two doses. This may be gradually increased by your doctor up to a maximum of 40 mg per day. For children weighing 30 kg or less, the initial dose is typically 5 mg once daily, which can be adjusted up to 20 mg per day. It is generally taken twice a day, in the morning and evening, at consistent times.

What are the possible side effects of CLOBA Syrup?

Common side effects of CLOBA Syrup can include drowsiness, sleepiness, tiredness, problems with coordination, difficulty speaking (slurred speech), drooling, changes in appetite, vomiting, constipation, cough, joint pain, and fever.

More serious but rare side effects include severe allergic reactions (like DRESS), severe skin reactions (such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), and suicidal thoughts or actions. You should contact your doctor immediately if you experience a rash, blisters, or any severe symptoms.

Is CLOBA Syrup safe during pregnancy or breastfeeding?

Pregnancy: CLOBA Syrup is generally not recommended during pregnancy. If taken regularly in the later stages of pregnancy, your baby may experience withdrawal symptoms after birth, such as agitation or shaking. Women of childbearing age should discuss effective non-hormonal birth control methods with their doctor, as hormonal contraceptives may be less effective while taking Clobazam. If you become pregnant while taking CLOBA Syrup, you should inform your doctor and consider enrolling in a pregnancy registry, like the North American Antiepileptic Drug Pregnancy Registry.

Breastfeeding: Clobazam passes into breast milk. Infants who are breastfed by mothers taking Clobazam may experience lethargy, drowsiness, or poor sucking. Your healthcare provider will help you weigh the potential benefits against the potential risks if you plan to breastfeed while taking this medication.

Can CLOBA Syrup be taken with other medications?

CLOBA Syrup can interact with various medications. It is crucial to inform your doctor and pharmacist about all prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• Opioids, Alcohol, and other CNS depressants: Taking CLOBA Syrup with opioids, alcohol, or other medicines that cause dizziness and sleepiness can significantly increase the risk of severe drowsiness, breathing problems, coma, and even death. Alcohol should be avoided during treatment.
• Hormonal Contraceptives: CLOBA Syrup may reduce the effectiveness of hormonal birth control (pills, patches, rings, implants, injections, or intrauterine devices). Alternative or additional non-hormonal birth control methods should be used.
• Other Medications: Interactions can occur with antidepressants, certain antifungal medications (e.g., fluconazole, ketoconazole), stomach acid reducers (e.g., omeprazole), and other antiepileptic drugs (e.g., valproate).

What precautions should be taken while using CLOBA Syrup?

• Do not stop suddenly: Never stop taking CLOBA Syrup abruptly without consulting your doctor, as this can lead to severe withdrawal symptoms, including an increase in seizure frequency or status epilepticus (seizures that won't stop). The dose should be gradually reduced under medical supervision.
• Drowsiness/Dizziness: CLOBA Syrup can cause drowsiness, dizziness, and problems with coordination. Avoid driving, operating heavy machinery, or performing other dangerous activities until you know how the medication affects you.
• Potential for Dependence: This medicine can be habit-forming, especially with prolonged use or at higher doses. Take it exactly as prescribed to minimize this risk.
• Underlying Health Conditions: Inform your doctor if you have a history of drug or alcohol abuse, depression, other mental illnesses, or problems with your liver, kidneys, or lungs.
• Elderly Patients: Use with caution in elderly patients due to increased sensitivity to side effects like drowsiness and dizziness, and a higher risk of falls.

What happens if a dose is missed?

If you miss a dose of CLOBA Syrup, 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 double doses to make up for a missed one. If you miss multiple doses, consult your healthcare provider for guidance.

How should CLOBA Syrup be stored?

CLOBA Syrup should be stored in its original bottle, in an upright position, at room temperature (between 20°C and 25°C or 68°F and 77°F). Keep it away from heat, moisture, and direct light, and out of the reach of children. Discard any unused oral suspension 90 days after the bottle has been opened for the first time.