Clobazam is an active pharmaceutical ingredient in the Benzodiazepine Derivatives group (N05BA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised December 29, 2025[1]
Zacco is a 1,5-benzodiazepine indicated in adults for the short-term symptomatic treatment (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. In treatment of anxiety states associated with affective disorders Zacco must be used only in conjunction with adequate treatments for the underlying disorder.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for short term symptomatic management of hyperarousal and agitation. Benzodiazepines do not possess antipsychotic properties. Zacco may be used as adjunctive therapy in epilepsy, in adults and children over 2 years if standard treatment with one or more anticonvulsants has failed.
Treatment of simple or complex partial epilepsy with or without secondary generalisation and treatment of all types of generalised epilepsy (tonic / clonic, myoclonic, absence seizures).
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised December 27, 2024[2]
1 INDICATIONS AND USAGE Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ( 1 )
How to take
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE .............................................................................................. 3 CONTRAINDICATIONS ....................................................................................................................
3 WARNINGS AND PRECAUTIONS .................................................................................................. 4 ADVERSE REACTIONS ..................................................................................................................
11 DRUG INTERACTIONS .................................................................................................................. 15 DOSAGE AND ADMINISTRATION ..............................................................................................
17 OVERDOSAGE ................................................................................................................................. 19 ACTION AND CLINICAL PHARMACOLOGY .............................................................................
Drug interactions
Known interactions involving Clobazam. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 451. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL393070074 · revised December 29, 2025
[2]FDA DailyMed · 07e0ae51-cc71-42… · revised December 27, 2024 [PDF]
[3]Health Canada (DPD) · 02238334 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
GBOfficial regulatory label· revised December 29, 2025[1]
4). Treatment should be given for the shortest possible duration. If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary.
Treatment of anxiety:
Treatment should be as short as possible. The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms.
e. including tapering-off process) must not exceed 8 to 12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so it should not take place without re-evaluation of the patient’s status with special expertise.
It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Adults:
The usual anxiolytic dose for adults is 20-30mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety. The lowest dose that can control symptoms should be used.
After improvement of the symptoms, the dose may be reduced. It should not be used for longer than 4 weeks. Due regard must be paid to the possibility of interference with alertness and reaction time. Long term chronic use as an anxiolytic is not recommended.
In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without re- evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Treatment should always be withdrawn gradually. Patients who have taken Zacco for a long time may require a longer period during which doses are reduced.
Elderly:
Doses of 10-20mg daily in anxiety may be used in the elderly, who are more sensitive to the effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments under careful observation. Treatment of epilepsy in association with one or more other anticonvulsants Adults: In epilepsy a starting dose of 5-15mg/day is recommended with increases of 10mg increments, increasing as necessary up to maximum of 60mg daily.
Elderly:
In elderly patients in the management of epilepsy with clobazam increased response and increased susceptibility to adverse reactions may occur. These patients require low initial doses with gradual increases under careful observation.
Paediatric population aged 2 years and above:
Zacco doses should be adapted individually. Doses can be taken once a day, or as 2 to 3 divided doses, keeping the total daily dose the same. When prescribed for children, treatment requires low initial doses and gradual dose increments under careful observation.
1 mg/kg/day for younger patients. 2 mg/kg/day at 7 days intervals, until the required clinical effect is achieved or side effects occur. 2mg/kg every week up to the target dose. 3 to 1mg/kg body weight daily is usually sufficient.
Paediatric population aged 1 month -2 years:
There is a lack of data regarding the use of the product in patients under 2 years old Zacco should not be used as an anticonvulsant treatment in children from 1 months to 2 years old unless under exceptional situations when there is a clear epilepsy indication.
1mg/kg/day as in this population the metabolic pathways for clobazam may not be fully mature. Up-to-date no precise dosage recommendations can be made for this population. During adjunctive therapy in epilepsy, in adults and children aged two years and above, the patient must be re-assessed after a period not exceeding 4 weeks and every 4 weeks thereafter in order to evaluate the need for continued treatment.
A break in therapy may be beneficial if drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment (including in poor-responding patients), it is recommended to gradually decrease the dosage since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment.
Hepatic and renal impairment (all indications):
Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and require low initial doses and gradual dose increments under careful observation. The maximum dose should not be exceeded. Zacco Oral Suspension is particularly recommended for children and adults with swallowing difficulties as it allows a secure and precise dosage.
The patient should be checked regularly at the start of the treatment in order to decrease if necessary, the dose or frequency of administration to prevent overdose due to accumulation. Method of administration For oral use only. Zacco can be given with or without food.
This product may settle during storage. Shake the bottle well before use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised December 29, 2025[1]
g. 4 Warnings and Precautions) Gastrointestinal disorders Common: dry mouth, nausea, constipation Skin and subcutaneous tissue disorders Uncommon: rash Not known: urticaria; Steven-Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome); Musculoskeletal and connective tissue disorders Not known: muscle spasms, muscle weakness General disorders and administration site conditions Very common: fatigue, especially at the beginning of treatment and when higher doses are used Not known: slow response to stimuli, hypothermia Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Investigations Uncommon: weight increased (particularly with high doses or in long-term treatment) Injury poisoning and procedural complications Uncommon: fall Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised December 29, 2025[1]
Switching between formulations In some individuals taking Zacco, clobazam reaches higher plasma levels than the same dose taken as a tablet. This may lead to an increased risk of respiratory depression and sedation, which may be most noticeable when switching to this medicine from tablets.
Therefore, caution must be taken when switching between clobazam products. Children under 2 years There is a lack of data regarding the use of the product in patients under 2 years old. For this reason, careful assessment and monitoring is required by the treating physician for use in children under 2 years for anticonvulsant treatment.
Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also Undesirable Effects).
Muscle weakness Clobazam can cause muscle weakness. Therefore, in patients with pre-existing muscle weakness or spinal or cerebellar ataxia or sleep apnoea, special observation is required and a dose reduction may be necessary. Clobazam is contraindicated in patients with myasthenia gravis.
Duration of treatment The duration of treatment should be as short as possible (see Posology). Extension beyond these periods should not take place without revaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used (for example Zacco) it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Depression and personality disorders Disinhibiting effects may be manifested in various ways.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised December 29, 2025[1]
1. • In patients with any history of drug or alcohol dependence (increased risk of development of dependence). • In patients with myasthenia gravis (risk of aggravation of muscle weakness). • In patients with severe respiratory insufficiency (risk of deterioration).
• In patients with sleep apnoea syndrome (risk of deterioration). • In patients with severe hepatic insufficiencies (risk of precipitating encephalopathy). • In breast-feeding women. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Zacco should not be used in children from 1 month to 2 years old unless under exceptional situations as an anticonvulsant treatment where there is a clear epilepsy indication.
This is not medical advice. Consult a qualified healthcare professional.
1 Dosing Information A daily dose of clobazam oral suspension greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability.
, 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose [see Clinical Studies ( 14 )]. Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.
Table 1. 2 Discontinuation or Dosage Reduction of Clobazam Oral Suspension To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue clobazam oral suspension or reduce the dosage.
Taper by decreasing the total daily dose by 5 to 10 mg/day on a weekly basis until discontinued. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. 3 )] .
3 Important Administration Instructions Instruct patients to read the “Instructions for Use” carefully for complete directions on how to properly dose and administer clobazam oral suspension. 3 )]. Shake clobazam oral suspension well before every administration.
When administering the oral suspension, use only the oral dosing syringe provided with the product. Each carton includes two syringes, but only one syringe should be used for dosing. The second oral syringe is reserved as a replacement in case the first syringe is damaged or lost.
Insert the provided adapter firmly into the neck of the bottle before first use and keep the adapter in place for the duration of the usage of the bottle. To withdraw the dose, insert the dosing syringe into the adapter and invert the bottle then slowly pull back the plunger to prescribed dose.
After removing the syringe from the bottle adapter, slowly squirt clobazam oral suspension into the corner of the patient’s mouth. Replace the cap after each use. The cap fits over the adapter when the adapter is properly placed. See clobazam oral suspension “Instructions for Use” for complete instruction on how to properly dose and administer the clobazam oral suspension.
4 Dosage Adjustments in Geriatric Patients Plasma concentrations at any given dose are generally higher in the elderly: proceed slowly with dose escalation. The starting dose should be 5 mg/day for all elderly patients. Then titrate elderly patients according to weight, but to half the dose presented in Table 1, as tolerated.
5 )]. 5 Dosage Adjustments in CYP2C19 Poor Metabolizers In CYP2C19 poor metabolizers, levels of N-desmethylclobazam, clobazam’s active metabolite, will be increased. Therefore, in patients known to be CYP2C19 poor metabolizers, the starting dose should be 5 mg/day and dose titration should proceed slowly according to weight, but to half the dose presented in Table 1, as tolerated.
5 )]. 6 Patients with Renal Impairment No dose adjustment is required for patients with mild and moderate renal impairment. There is no experience with clobazam oral suspension in patients with severe renal impairment or end stage renal disease (ESRD).
3 )]. 7 Dosage Adjustments in Patients with Hepatic Impairment Clobazam oral suspension is hepatically metabolized; however, there are limited data to characterize the effect of hepatic impairment on the pharmacokinetics of clobazam oral suspension.
For this reason, proceed slowly with dosing escalations. For patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9), the starting dose should be 5 mg/day in both weight groups. Then titrate patients according to weight, but to half the dose presented in Table 1, as tolerated.
If necessary and based upon clinical response, start an additional titration on day 21 to the maximum dose (20 mg/day or 40 mg/day, depending on the weight group). There is inadequate information about metabolism of clobazam oral suspension in patients with severe hepatic impairment.
3 )].
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,698 reports total. [4]
Seizure 400
Off Label Use 285
Drug Ineffective 238
Somnolence 168
Hospitalisation 79
Fatigue 78
Drug Interaction 77
Generalised Tonic-Clonic Seizure 75
Status Epilepticus 66
Product Dose Omission Issue 65
Decreased Appetite 64
Multiple-Drug Resistance 64
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised December 27, 2024[2]
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During its development for the adjunctive treatment of seizures associated with LGS, clobazam oral suspension was administered to 333 healthy volunteers and 300 patients with a current or prior diagnosis of LGS, including 197 patients treated for 12 months or more.
The conditions and duration of exposure varied greatly and included single- and multiple- dose clinical pharmacology studies in healthy volunteers and two double-blind studies in patients with LGS (Study 1 and 2) [see Clinical Studies ( 14 )].
Only Study 1 included a placebo group, allowing comparison of adverse reaction rates on clobazam oral suspension at several doses to placebo. Adverse Reactions Leading to Discontinuation in an LGS Placebo Controlled Clinical Trial (Study 1) The adverse reactions associated with clobazam oral suspension treatment discontinuation in ≥1% of patients in decreasing order of frequency included lethargy, somnolence, ataxia, aggression, fatigue, and insomnia.
Most Common Adverse Reactions in an LGS Placebo Controlled Clinical Trial (Study 1) Table 3 lists the adverse reactions that occurred in ≥5% of clobazam oral suspension-treated patients (at any dose), and at a rate greater than placebo-treated patients, in the randomized, double- blind, placebo-controlled, parallel group clinical study of adjunctive AED therapy for 15 weeks (Study 1).
Table 3. 2 Postmarketing Experience These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized by system organ class.
Blood Disorders:
Anemia, eosinophilia, leukopenia, thrombocytopenia Eye Disorders: Diplopia, vision blurred Gastrointestinal Disorders: Abdominal distention General Disorders and Administration Site Conditions: Hypothermia Investigations: Hepatic enzyme increased Musculoskeletal: Muscle spasms Psychiatric Disorders: Agitation, anxiety, apathy, confusional state, depression, delirium, delusion, hallucination Renal and Urinary Disorders: Urinary retention Respiratory Disorders : Aspiration, respiratory depression Skin and Subcutaneous Tissue Disorders: Rash, urticaria, angioedema, and facial and lip edema
USOfficial regulatory label· Warnings and precautions· revised December 27, 2024[2]
5 WARNINGS AND PRECAUTIONS Somnolence or Sedation: Monitor for central nervous system (CNS) depression. 1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including clobazam oral suspension, and opioids may result in profound sedation, respiratory depression, coma, and death.
Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe clobazam oral suspension concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
1 )]. 2 Abuse, Misuse, and Addiction The use of benzodiazepines, including clobazam oral suspension, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. 2 )]. , using a standardized screening tool).
Use of clobazam oral suspension, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clobazam oral suspension along with monitoring for signs and symptoms of abuse, misuse, and addiction.
, opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 2 )]. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.
Acute Withdrawal Reactions The continued use of benzodiazepines, including clobazam oral suspension, may lead to clinically significant physical dependence. 3 )] . 3 )]. 2 )] . 5 Somnolence or Sedation Clobazam oral suspension causes somnolence and sedation.
In clinical trials, somnolence or sedation was reported at all effective doses and was dose-related. In general, somnolence and sedation begin within the first month of treatment and may diminish with continued treatment. Prescribers should monitor patients for somnolence and sedation, particularly with concomitant use of other central nervous system depressants.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised December 27, 2024[2]
4 CONTRAINDICATIONS Clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. 7 )]. History of hypersensitivity to the drug or its ingredients ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
20 STORAGE AND STABILITY .......................................................................................................... 23 SPECIAL HANDLING INSTRUCTIONS ........................................................................................
23 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................................. 23 PART II: SCIENTIFIC INFORMATION ..................................................................................... 24 PHARMACEUTICAL INFORMATION ..........................................................................................
33 PATIENT MEDICATION INFORMATION ................. ERROR! BOOKMARK NOT DEFINED.
Teva-Clobazam Product Monograph 3 of 46 TEVA-CLOBAZAM Clobazam Tablets PART I:
HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Tablet 10 mg colloidal silicon dioxide, lactose monohydrate, magnesium stearate, sodium starch glycolate, starch and talc INDICATIONS AND CLINICAL USE TEVA-CLOBAZAM (clobazam) is indicated for: adjunctive therapy in patients with epilepsy who are not adequately stabilized with their current anticonvulsant therapy.
Geriatrics (> 65 years of age):
The efficacy of TEVA-CLOBAZAM in adults aged 65 and over has not been established (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY sections). Long-term use of TEVA-CLOBAZAM should be avoided in elderly patients. Enhanced monitoring is recommended (see WARNINGS AND PRECAUTIONS, Falls and fractures; DOSAGE AND ADMINISTRATION, Dosing considerations).
CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. These reactions may not be limited to rash, urticaria, and hypotension. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
myasthenia gravis (risk of aggravation of muscle weakness) narrow angle glaucoma any history of drug or alcohol dependence (increased risk of development of dependence) severe respiratory insufficiency sleep apnoea syndrome (risk of deterioration) severe impairment of liver function (risk of precipitating encephalopathy) Teva-Clobazam Product Monograph 4 of 46 during first trimester of pregnancy and breast-feeding (see WARNINGS AND PRECAUTIONS section) Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including TEVA-CLOBAZAM, can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs. Assess each patient’s risk prior to prescribing TEVA-CLOBAZAM Monitor all patients regularly for the development of these behaviours or conditions.
TEVA-CLOBAZAM should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, like TEVA-CLOBAZAM, can produce severe or life-threatening withdrawal symptoms. Avoid abrupt discontinuation or rapid dose reduction of TEVA-CLOBAZAM.
Terminate treatment with TEVA-CLOBAZAM by gradually tapering the dosage schedule under close monitoring. (see WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of TEVA-CLOBAZAM and opioids may result in profound sedation, respiratory depression, coma and death (see WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
WARNINGS AND PRECAUTIONS General Clobazam can cause muscle weakness. TEVA-CLOBAZAM is contraindicated in patients with myasthenia gravis. In patients with pre-existing muscle weakness or with spinal or cerebellar ataxia, special observation is required and a dose reduction may be necessary (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION sections).
Additive effects are to be expected if TEVA-CLOBAZAM is combined with alcohol or drugs with central nervous system depressant effects. Moreover, concomitant consumption of alcohol Teva-Clobazam Product Monograph 5 of 46 can increase the serum […]
Suicide may be precipitated in patients who are depressed and aggressive behaviour towards self and others may be precipitated. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.
Before treatment of anxiety states associated with affective disorders, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. In patients with anxiety associated with depression, clobazam must be used only in conjunction with adequate treatments for the underlying disorder.
Use of benzodiazepine (such as clobazam) alone, can precipitate suicide in such patients. Patients with schizophrenic or other psychotic illnesses Benzodiazepines are not recommended for the primary treatment of patients with schizophrenic or other psychotic illnesses.
Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
8). They are more likely to occur in children and the elderly. Should this occur, use of the medicinal product should be discontinued. Suicidal ideation/suicide attempt/ suicide and depression Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for clobazam.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Some epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including clobazam. 8). Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a […]
Prescribers should caution patients against engaging in hazardous activities requiring mental alertness, such as operating dangerous machinery or motor vehicles, until the effect of clobazam oral suspension is known. 6 Serious Dermatological Reactions Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam oral suspension in both children and adults during the postmarketing period.
Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment initiation or when re-introducing therapy. Clobazam oral suspension should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.
If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered [see Contraindications ( 4 )]. 7 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including clobazam oral suspension.
These events can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection.
Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, the patient should be evaluated immediately. Clobazam oral suspension should be discontinued if an alternative etiology for the signs or symptoms cannot be established [see Contraindications ( 4 )].
8 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including clobazam oral suspension, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
7) of suicidal thinking or behavior compared to patients randomized to placebo. 24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.
There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed.
Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.
Table 2 shows absolute and relative risk by indication for all evaluated AEDs. Table 2. 9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing clobazam oral suspension or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.
Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers. 1 )]. Monitor neonates exposed to clobazam during pregnancy or labor for signs of sedation and monitor neonates exposed to clobazam during pregnancy for signs of withdrawal; manage these neonates accordingly.