Clob 10 mg

Description

Indications
Clobazam is indicated for the treatment of acute and chronic anxiety disorders, which may present with symptoms such as anxiety, tension, restlessness, excitement, irritability, sleep disturbances due to emotional causes, and psychovegetative or psychosomatic disorders (e.g., affecting the cardiovascular or gastrointestinal systems). It is also useful in addressing emotional instability.

For patients experiencing anxiety or depression associated with depression, Clobazam should only be used in combination with appropriate adjunctive treatment. Benzodiazepines alone can increase the risk of suicide in such cases. Before prescribing for anxiety linked to emotional instability, it is essential to assess whether the patient has an underlying depressive disorder that may require additional or alternative treatment.

In cases of schizophrenia or other psychotic conditions, benzodiazepines, including Clobazam, should only be used as an adjunctive therapy, not as primary treatment.

Clobazam is also indicated as an adjunctive treatment in epilepsy for patients whose condition is not adequately controlled by anticonvulsant monotherapy.
Use this medicine only under the guidance of a registered physician.

Pharmacology
Clobazam binds to specific sites associated with the chloride ion channel on the post-synaptic GABA receptor, which is found in various parts of the central nervous system (CNS), such as the limbic system and reticular formation. By enhancing the GABAergic inhibitory effect, Clobazam increases the duration the chloride ion channel remains open, leading to membrane hyperpolarization and stabilization.

Dosage
The dosage of Clobazam must be tailored to the patient’s condition, the severity of symptoms, and their clinical response. The goal is to administer the lowest effective dose to minimize interference with alertness and reaction time.

• For Anxiety Treatment:
  • Adults and adolescents over 15 years: The starting dose is typically 20 mg daily, with the option to increase if necessary. The total daily dose should generally not exceed 30 mg.
  • Elderly patients: Due to increased sensitivity and susceptibility to side effects, elderly individuals may require lower starting doses with gradual increases. A typical maintenance dose ranges from 10 to 15 mg daily.
  • Children aged 3 to 15 years: Due to greater sensitivity to adverse effects, lower starting doses and gradual increments under careful supervision are advised. A typical dose is 5 to 10 mg daily. Benzodiazepines should only be prescribed to children after a thorough assessment.
• Secondary Dosage Adjustments: Once symptoms improve, the dose may be reduced accordingly.
• Timing of Doses: It is recommended that the larger portion of the daily dose be taken in the evening if the total dose is divided throughout the day.
• Duration of Treatment: Treatment duration should be as brief as possible, with reassessment after no more than 4 weeks. Typically, treatment should not exceed 8 to 12 weeks, and any extension should be based on a thorough re-evaluation by a specialist.
• Discontinuation: It is essential to gradually reduce the dose under medical supervision after prolonged use to avoid withdrawal symptoms.
• For Epilepsy Treatment (when used in combination with other anticonvulsants):
  • Adults and adolescents over 15 years: Begin with a low dose (5 to 15 mg daily), increasing gradually up to a maximum of 80 mg per day as needed.
  • Children aged 3 to 15 years: Treatment typically starts at 5 mg daily, with a maintenance dose of 0.3 to 1.0 mg/kg of body weight. As with anxiety treatment, careful monitoring is required.
  • Elderly patients: Similar to other treatments, starting doses should be low, with gradual increments under close supervision.
• Discontinuation of Treatment: Similar to anxiety treatment, clobazam should not be suddenly withdrawn, particularly after extended use, to prevent withdrawal symptoms or increased seizure risk.

Use this medicine only under the guidance of a registered physician.

Administration
Clobazam tablets can be taken whole or crushed and mixed with applesauce. The 10 mg tablets can be split in half to administer 5 mg doses. The medicine can be taken with or without food.
Use this medicine only under the guidance of a registered physician.

Interactions

• Alcohol: Concurrent use can increase Clobazam’s effects by 50%, heightening the risk of side effects.
• Central Nervous System Depressants: Combining Clobazam with other CNS depressants (such as antipsychotics, anxiolytics, antidepressants, anticonvulsants, sedative antihistamines, anesthetics, or narcotics) can enhance sedative effects. Care is needed, particularly in cases of intoxication.
• Opioids: The combination of benzodiazepines like Clobazam and opioids significantly increases the risk of sedation, respiratory depression, coma, and even death due to their combined CNS depressant effects.
• Anticonvulsants: When used alongside anticonvulsants, Clobazam’s dosage must be carefully adjusted to prevent interactions, especially with drugs like valproic acid, phenytoin, carbamazepine, and stiripentol.
• Narcotic Analgesics: Clobazam may enhance the euphoric effects of narcotics, potentially leading to increased psychological dependence.
• Muscle Relaxants and Nitrous Oxide: The effects of these agents may be intensified when used together with Clobazam.
• CYP 2C19 Inhibitors: Strong or moderate CYP2C19 inhibitors can increase the active metabolite (N-desmethylClob), requiring dosage adjustments.

Contraindications
Clobazam is contraindicated in:

• Patients with hypersensitivity to Clobazam or its components.
• Those with myasthenia gravis, severe respiratory insufficiency, or sleep apnea syndrome.
• Individuals with severe liver impairment or pregnant women.
• Children aged 6 months to 3 years, unless prescribed for specific anticonvulsant treatment.

Side Effects
Common side effects include somnolence, sedation, dizziness, and dry mouth. Serious reactions may include severe skin conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, respiratory depression, muscle weakness, and liver or kidney issues. Regular monitoring is required during treatment, especially for long-term use.

Pregnancy & Lactation

• Pregnancy: Clobazam is not recommended during the first trimester or for women not using contraception. It should only be used if the benefits outweigh the risks.
• Lactation: Clobazam passes into breast milk and should not be used by breastfeeding women.

Precautions & Warnings

• Serious Skin Reactions: Monitor for signs of Stevens-Johnson syndrome and discontinue use if suspected.
• Respiratory Depression: Use with caution in patients with pre-existing respiratory conditions.
• Tolerance in Epilepsy: The anticonvulsant effects of Clobazam may decrease over time due to tolerance.
• Suicidality: Increased risk of suicidal behavior, particularly in patients with pre-existing depression.

Therapeutic Class
Benzodiazepine hypnotics

Storage Conditions
Store below 30°C and protect from light. Keep out of reach of children. Do not use after the expiration date.