Clozam 5

CLOZAM 5 by ABBOTT

CLOZAM 5 is a medication manufactured by Abbott, containing Clobazam as its active ingredient. It belongs to the benzodiazepine class of medicines, known for their calming effects on the brain.

Composition

• Active Ingredient: Clobazam 5 mg

Uses

CLOZAM 5 is primarily prescribed for the management of:

• Epilepsy/Seizures: It is used to control seizures, including those associated with Lennox-Gastaut syndrome, by suppressing abnormal electrical activity in the brain.
• Severe Anxiety: It helps reduce symptoms of excessive anxiety, worry, restlessness, and irritability. It may also be used as an adjunct in certain mental illnesses like schizophrenia and for the short-term relief of alcohol withdrawal syndrome symptoms.

Dosage and Administration

CLOZAM 5 should be taken as advised by a healthcare professional.

• It can be taken with or without food, but it is recommended to take it at the same time each day to maintain consistent medicine levels.
• Tablets should be swallowed whole; they can also be split in half along the score or crushed and mixed with soft food like applesauce.
• Adults: A typical starting dose is 5 mg daily, with gradual increases as tolerated. Daily doses greater than 5 mg are usually administered in divided doses. The maximum recommended daily dose can range from 20 mg to 40 mg, and up to 60 mg/day in severe conditions.
• Children (2 years and older): Dosing starts at 5 mg daily and can be titrated up to 20 mg daily based on body weight and response.
• Elderly Patients: A lower initial dose (e.g., 10-20 mg daily) is generally required, with caution for dose increases.
• Important: Do not stop taking CLOZAM 5 suddenly without consulting a doctor, as abrupt discontinuation can lead to severe withdrawal symptoms and increased seizure frequency.

Side Effects

Common side effects may include:

• Tiredness, sleepiness, dizziness, sedation
• Slurred speech, speech disorder
• Constipation, dry mouth, decreased appetite, nausea
• Headache, irritability, aggression, restlessness
• Tremors, abnormality of voluntary movements

Serious side effects, though less common, can include:

• Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, especially within the first 8 weeks of treatment.
• Suicidal behavior and ideation.
• Profound sedation and respiratory depression, particularly when used concomitantly with opioids.

Precautions

• Dependence and Withdrawal: CLOZAM 5 has a high potential for addiction and physical dependence. It should only be taken as prescribed, and withdrawal should be managed gradually under medical supervision.
• Alcohol Consumption: Avoid alcohol as it can significantly increase drowsiness and other adverse effects, potentially leading to life-threatening conditions.
• Pregnancy and Breastfeeding: CLOZAM 5 may be unsafe during pregnancy and is probably unsafe during breastfeeding, as it can cause adverse effects in the baby. Consult your doctor if pregnant, planning pregnancy, or breastfeeding.
• Driving and Operating Machinery: This medicine can cause dizziness, sleepiness, and affect concentration or memory. Patients should avoid driving or operating heavy machinery until they understand how CLOZAM 5 affects them.
• Hepatic and Renal Impairment: Use with caution in patients with kidney or liver disease. Dose adjustments may be necessary, and liver function should be monitored regularly in patients with impaired liver function.
• Drug Interactions: Concomitant use with opioids, other central nervous system (CNS) depressants, anti-anxiety medicines, and certain other drugs can increase the risk of severe side effects. Grapefruit or its juice should be avoided as it can increase Clobazam levels in the blood.
• Monitoring: Regular monitoring of blood and liver functions may be required with long-term use.

Storage

Store CLOZAM 5 below 30°C (between 15°C and 30°C or 20°C and 25°C) in a dry place, away from direct sunlight, heat, and moisture. Keep it out of sight and reach of children.

CLOZAM 5, manufactured by Abbott, contains Clobazam 5mg as its active ingredient.

What is CLOZAM 5 used for?

CLOZAM 5 is primarily used to treat epilepsy (seizures) and severe anxiety. It can also be used as an add-on therapy for Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy, and to manage short-term symptoms of alcohol withdrawal syndrome.

How does CLOZAM 5 work?

CLOZAM 5, a benzodiazepine, works by increasing the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the brain. This helps to suppress abnormal and excessive activity of nerve cells in the brain, thereby reducing seizures and anxiety.

What is the usual dosage of CLOZAM 5?

The dosage of CLOZAM 5 varies depending on the patient's condition, age, and weight, and should always be as advised by a doctor. For adults, in the short-term management of anxiety or as an adjunct in epilepsy, a recommended dose is typically 20-30 mg per day, given as a single dose at night or in divided daily doses, and may increase up to 60 mg/day in severe conditions. For children (3-12 years), the starting dose may be 125 mcg/kg twice daily, gradually increased. For elderly patients, a lower dose of 10-20 mg daily is usually recommended. It is important to take it at the same time each day to maintain consistent levels in the body.

What are the possible side effects of CLOZAM 5?

Common side effects include sleepiness, drowsiness, fatigue, dizziness, headache, dry mouth, constipation, nausea, decreased appetite, irritability, and speech disorder. More serious but rare side effects can include severe skin reactions, suicidal thoughts, or changes in behavior. If you experience any severe or unusual side effects, consult your doctor immediately.

Is CLOZAM 5 safe during pregnancy or breastfeeding?

CLOZAM 5 is generally not recommended during pregnancy as it may be unsafe and animal studies have shown harmful effects on the developing baby. If used late in pregnancy, it can result in sedation and/or withdrawal symptoms in the newborn.

For breastfeeding mothers, CLOZAM 5 is probably unsafe as the drug may pass into breast milk and potentially harm the baby. Limited data suggests clobazam levels in milk are low, but monitoring the infant for sleepiness is advised, especially during long-term use. Always consult your doctor if you are pregnant or breastfeeding.

Can CLOZAM 5 be taken with other medications?

Taking CLOZAM 5 with other Central Nervous System (CNS) depressants, including alcohol, can increase the risk of sedation and drowsiness. Opioids taken with CLOZAM 5 can lead to profound sedation, respiratory depression, coma, and even death. CLOZAM 5 can also reduce the effectiveness of hormonal contraceptives; therefore, non-hormonal contraception is recommended during and for 28 days after treatment. Inform your doctor about all medications you are taking to avoid potential drug interactions.

What precautions should be taken with CLOZAM 5?

Avoid alcohol consumption as it can increase dizziness and drowsiness. Do not drive or operate heavy machinery until you know how the medicine affects you due to potential dizziness and sleepiness. Do not stop taking CLOZAM 5 suddenly, as it can increase seizure frequency and cause withdrawal symptoms. The dosage should be gradually reduced under medical supervision. Caution is advised for patients with kidney or liver disease, and regular monitoring of liver function may be required during long-term use. Report any unusual skin reactions, suicidal thoughts, or behavioral changes to your doctor.

What happens if a dose of CLOZAM 5 is missed?

If you miss a dose of CLOZAM 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 double the dose to make up for a missed one. Consistent dosing is important for seizure control.

How should CLOZAM 5 be stored?

CLOZAM 5 should be stored below 30°C or at controlled room temperature (15-30°C), away from heat, moisture, and direct light. Keep it out of reach of children.