Registered Kenya · PPB

CLOBABERG

CLOBAZAM BP

H2017/CTD4859/417 CLOBAZAM BP 10 MG GENERIC/BIOSIMILARS nervous system INN generic

What it does

Clobazam is a medication that belongs to the benzodiazepine class, commonly used to treat seizures and anxiety.

Commonly used for: seizures (epilepsy), anxiety

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2017/CTD4859/417
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
CLOBAZAM BP
Dosage form
CLOBAZAM BP 10 MG
Strength
-
Pack size
10 X 10’S BLISTER PACK
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
N05BA - Benzodiazepine derivatives
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
21241
Manufacturer / MAH
Syner-med Pharmaceuticalsltd
Applicant / LTR
MADRAS PHARMACEUTICALS
Country of origin
FOREIGN
Manufacturer location
Gayatri House,ICD Road, Off Mombasa Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:14:09 · updated 2026-08-03 04:14:29

Drug Interactions

48
Check interactions

Pharmacodynamic Warnings

Clobazam appears in TABLE 11: Drugs with CNS depressant effects

Severe (9)

Benzodiazepines - increases exposure

Cobicistat moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Benzodiazepines - increases exposure

Ritonavir is predicted to increase the exposure to benzodiazepines (diazepam, flurazepam). Avoid.

Severe Theoretical

Benzodiazepines - increases exposure

Idelalisib moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Benzodiazepines - decreases exposure

Lorlatinib moderately decreases the exposure to benzodiazepines (midazolam). Avoid.

Severe Study

Benzodiazepines - decreases exposure

Lumacaftor is predicted to decrease the exposure to benzodiazepines (midazolam). Avoid.

Severe Theoretical

Benzodiazepines - increases exposure

Clarithromycin moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Benzodiazepines - increases exposure

Etravirine is predicted to increase the exposure to benzodiazepines (diazepam). Avoid.

Severe Theoretical

Benzodiazepines - affects effects

Efavirenzispredictedtoaltertheeffectsofbenzodiazepines (midazolam).Avoid.oTheoretical

Severe Theoretical

Benzodiazepines - increases exposure

Ribociclib moderately increases the exposure to benzodiazepines (midazolam). Avoid.

Severe Study

Moderate (19)

Benzodiazepines - increases exposure

Miconazole is predicted to increase the exposure to benzodiazepines (alprazolam). Use with caution and adjust dose.

Moderate Theoretical

Benzodiazepines - decreases exposure

Monoclonal antibodies (tocilizumab) are predicted to decrease the exposure to benzodiazepines (alprazolam, diazepam, midazolam). Monitor and adjust dose.

Moderate Theoretical

Benzodiazepines - increases exposure

Berotralstat moderately increases the exposure to benzodiazepines (midazolam). Monitor and adjust dose.

Moderate Study

Benzodiazepines - increases concentration

Cenobamate might increase the concentration of benzodiazepines (clobazam). Monitor and adjust dose. Also see TABLE 11 p. 1519.

Moderate Theoretical

Benzodiazepines - decreases exposure

Cenobamatemoderatelydecreasestheexposureto benzodiazepines(midazolam).Adjustdose.oStudy → AlsoseeTABLE11p.1519

Moderate Study

Unknown (20)

Benzodiazepines - decreases exposure

Apalutamide is predicted to decrease the exposure to benzodiazepines (diazepam). Avoid or monitor.

Unknown Study

Benzodiazepines - increases exposure

Dronedarone is predicted to increase the exposure to benzodiazepines (alprazolam).

Unknown Study

Benzodiazepines - increases concentration

Stiripentol increases the concentration of benzodiazepines (clobazam).

Unknown Study

Benzodiazepines - increases exposure

Antifungals, azoles (fluconazole, isavuconazole, posaconazole) are predicted to increase the exposure to benzodiazepines (alprazolam).

Unknown Study

Benzodiazepines - increases exposure

Bulevirtideslightlyincreasestheexposuretobenzodiazepines (midazolam).oTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Clobazam is a medication that belongs to the benzodiazepine class, commonly used to treat seizures and anxiety.

What it treats

  • seizures (epilepsy)
  • anxiety

How it works

Clobazam works by calming the brain and nervous system, which helps reduce seizures and anxiety.

Who it's for

Clobazam is for people experiencing seizures or anxiety disorders.

Drug class

Benzodiazepines

Cautions

  • • Be careful when taking other medications that can also cause drowsiness or sedation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Clobazam

BNF-referenced

Clobazam is a 1,5-benzodiazepine used primarily in the management of epilepsy and anxiety disorders. It is recognized for its ability to enhance GABAergic neurotransmission, leading to increased inhibitory effects on neuronal excitability. This drug is particularly valuable in treating conditions characterized by excessive neuronal firing.

Indications

  • Epilepsy
  • Anxiety disorders (short-term use)

Dosage

Children: Refer to the BNF for Children for specific dosing information tailored to pediatric patients.

Adults: 20–30 mg daily in divided doses, with gradual increases based on clinical response and severity of anxiety if necessary.

Mechanism of action

Clobazam binds to the benzodiazepine site on the GABA<sub>A</sub> receptor, specifically at the interface of the α<sub>2</sub> and γ<sub>2</sub> subunits. This binding potentiates GABAergic neurotransmission, causing chloride channels to open, resulting in hyperpolarization of neurons. The increased chloride conductance raises the action potential threshold, thus decreasing the firing frequency of neurons.

Pharmacodynamics

As a benzodiazepine, clobazam enhances GABAergic transmission, leading to depression of central nervous system (CNS) activity. Its effects include increased neuronal excitability thresholds and reduced frequency of neuron firing, making it effective in conditions related to excessive excitatory activity. Clobazam does not significantly prolong the QTc interval at therapeutic doses, indicating its cardiovascular safety profile.

Pharmacokinetics

Clobazam is well absorbed after oral administration, with peak plasma concentrations typically reached within 1 to 4 hours. It has a half-life that allows for once or twice daily dosing. The drug undergoes hepatic metabolism, primarily via CYP enzymes, and metabolites may have therapeutic activity. Renal impairment may necessitate caution and potential dose adjustments, while hepatic impairment can also affect drug clearance.

Contra-indications

  • Respiratory depression
  • Severe cutaneous adverse reactions
  • Organic brain changes
  • Muscle weakness

Adverse effects

  • Drowsiness
  • Dizziness
  • Apathy
  • Ataxia
  • Nausea
  • Visual impairment
  • Headache
  • Dry mouth
  • Constipation
  • Decreased appetite
  • Dependence with prolonged use
  • Personality change
  • Psychotic disorder
  • Abnormal gait
  • Movement disorders
  • Libido loss

Interactions

  • Cenobamate (moderate - increases concentration)
  • Moclobemide (moderate - increases exposure)
  • Cannabidiol (moderate - increases exposure)
  • Stiripentol (unknown - increases concentration)

Precautions

  • Use with caution in hepatic impairment
  • Use with caution in renal impairment
  • Monitor plasma concentrations in patients with severe anxiety or those on long-term treatment
  • Avoid abrupt withdrawal to prevent dependence
  • May cause drowsiness, impairing the ability to drive or perform skilled tasks
  • Care must be taken to avoid confusion with clonazepam

Pregnancy

Clobazam should be used with caution during pregnancy, particularly in the first trimester, due to potential risks to the fetus.

Breast-feeding

Benzodiazepines are present in breast milk, and clobazam should be avoided if possible during breastfeeding. If used, infants should be monitored for sedation and feeding difficulties.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets: 50 mg
  • Oral suspension: 25 mg per 1 ml
BNF 85 (British National Formulary) p.391 BNF for Children 2019-2020 p.247 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Clobazam

PubChem CID 2789

Molecular formula: C16H13ClN2O2

Mechanism of action

The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully understood but is thought to involve the potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABA<sub>A</sub> receptor. Specifically, clobazam binds to the interface of the α<sub>2</sub> and γ<sub>2</sub>-subunit of the GABA<sub>A</sub> receptor. It has a great affinity for the α<sub>2</sub> subunit than the α<sub>1</sub> subunit compared to other 1,4‐benzodiazepines.Binding of clobazam to the GABA<sub>A</sub> receptor causes chloride channels to open, resulting in an influx of chloride and thus hyperpolarization of neurons.

Pharmacodynamics

Clobazam belongs to the benzodiazepine class of drugs. Clobazam acts on the GABA<sub>A</sub> receptor to increase GABAnergic transmission, particularly chloride conductance in neurons. This causes neuronal hyperpolarization, resulting in an increase in the action potential threshold and reducing neuron firing frequency. Consequently, the general neuronal activity of the central nervous system is depressed; therefore, clobazam can be used to treat diseases caused by excessive excitatory action potentials. The effect of clobazam 20 mg and 80 mg administered twice daily on QTc interval was evaluated in a randomized, evaluator-blinded, placebo-, and active-controlled (moxifloxacin 400 mg) parallel thorough QT study in 280 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc based on the Fridericia correction method was below 10 ms, the threshold for regulatory concern. Thus, at a dose two times the maximum recommended dose, clobazam did not prolong the QTc interval to any clinically relevant extent.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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The same active ingredient registered across other registries we cover - including different brands.