Adult: 1 mg via slow IV inj or infusion over at least 2 minutes. May repeat dose if necessary. Max: 20 mg daily. Dosage recommendations may vary between countries (refer to specific local guidelines). Child: 0.5 mg via slow IV inj or infusion. Dosage recommendations may vary among individual products or between countries (refer to specific product guidelines).
Oral Epilepsy
Adult: Monotherapy or adjunctive therapy in the treatment of most forms of epilepsy including typical and atypical absences (Lennox-Gastaut syndrome also known as petit mal variant), nodding spasms, primary or secondary generalised tonic-clonic seizures (grand-mal), partial (focal) seizures, and various forms of myoclonic seizures, myoclonus, and associated abnormal movements: Initially, 1 mg daily, gradually increased over 2-4 weeks. Maintenance: 4-8 mg daily. Max: 20 mg daily. Daily doses are given in 3-4 divided doses; largest dose must be given at bedtime if doses are not equally divided. Once maintenance dose is obtained, daily amount may be given as a single dose at night. Alternatively, an initial dose of 1.5 mg daily in 3 divided doses may be given; increased by increments of 0.5-1 mg every 3 days until seizure control is achieved. Max: 20 mg daily. Dose must be individually adjusted according to patient's clinical response and tolerance. Dosage recommendations may vary among individual products or between countries (refer to specific product guidelines). Elderly: Initially, 0.5 mg daily, gradually increased over 2-4 weeks. Maintenance: 4-8 mg daily. Max: 20 mg daily. Daily doses are given in 3-4 divided doses; largest dose must be given at bedtime if doses are not equally divided. Once maintenance dose is obtained, daily amount may be given as a single dose at night. Child: ≤10 years or ≤30 kg: Initially, 0.01-0.03 mg/kg daily (Max initial dose: 0.05 mg/kg daily) given in 2 or 3 divided doses; may be increased by no more than 0.25-0.5 mg every 3rd day until a maintenance dose of approx. 0.1 mg/kg daily has been reached or seizure control is achieved. Max: 0.2 mg/kg daily. Alternative dose recommendation: 1 month to 5 years Initially, up to 0.25 mg daily; 6-12 years Initially, up to 0.5 mg daily. Usual maintenance dose: 1-11 months 0.5-1 mg daily; 1-5 years 1 mg daily; 6-12 years 3-6 mg daily. Daily doses are given in 3-4 divided doses; largest dose must be given at bedtime if doses are not equally divided. Once maintenance dose is obtained, daily amount may be given as a single dose at night. Dosage recommendations and age range of use may vary among individual products or between countries (refer to specific product guidelines).
Oral Panic disorder with or without agoraphobia
Adult: Initially, 0.25 mg bid, increased after 3 days to a target dose of 1 mg daily. Some patients may require doses up to Max of 4 mg daily. Doses may be taken as a single dose at bedtime to minimise drowsiness. Dosage and treatment recommendations may vary among individual products or between countries (refer to specific product guidelines). Elderly: Initiate at low doses; monitor closely.
What are the brands available for Clonazepam in Malaysia?
Rivotril
Special Patient Group
Concomitant use with opioids: Use the lowest effective dose for the shortest possible duration.
Hepatic Impairment
Epilepsy; Status epilepticus:
Mild to moderate: Use the lowest effective dose. Severe: Contraindicated.
Panic disorder with or without agoraphobia:
Significant: Contraindicated.
Administration
Clonazepam May be taken with or without food.
Reconstitution
Intravenous:
IV inj: Dilute ampoule with 1 mL water for inj. IV infusion: Dilute 1 mg ampoule in at least 85 mL (e.g. 3 ampoules in 250 mL) of 0.9% NaCl, 5% or 10% glucose, or 0.45% NaCl and 2.5% glucose solutions.
Incompatibility
Concentrated solution for inj/infusion: May precipitate with Na bicarbonate. May lead to significant reduction of clonazepam concentration (up to 50%, particularly if stored over 24 hours in warm, ambient conditions) when infused using PVC-containing plastic infusion bags and sets.
Contraindications
Acute narrow-angle glaucoma, acute pulmonary insufficiency, severe respiratory insufficiency, sleep apnoea, myasthenia gravis, comatose state. Severe (epilepsy/status epilepticus) or significant (panic disorder) hepatic impairment.
Special Precautions
Patient with history of depression and/or suicide attempts, porphyria, difficulty handling secretions, fall risk, history of alcohol or drug abuse, pre-existing respiratory disease (e.g. COPD), spinal or cerebellar ataxia, open-angle glaucoma. Not recommended for the primary treatment of psychotic illness. Avoid abrupt withdrawal. Debilitated patients. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Sleep-related activities (e.g. sleep-driving, cooking, eating), suicidal ideation and behaviour, psychological dependence, respiratory depression, tolerance, loss of effect (long-term use); worsening of seizures (in patients with multiple seizure types); psychiatric and paradoxical reactions (e.g. restlessness, agitation, hallucinations), anterograde amnesia; hypersalivation and increased bronchial secretion (infants and children); thrombophlebitis (IV). Cardiac disorders: Cardiac failure, cardiac arrest. Eye disorders: Diplopia, nystagmus. Gastrointestinal disorders: Constipation. Hepatobiliary disorders: Abnormal LFTs. Immune system disorders: Allergic reactions.
Injury, poisoning and procedural complications: Falls, fractures. Musculoskeletal and connective tissue disorders: Muscle weakness. Nervous system disorders: Dizziness, drowsiness, somnolence, fatigue, coordination disturbances, headache, poor concentration, disorientation, confusion, dysarthria, ataxia. Skin and subcutaneous tissue disorders: Rarely, urticaria, transient hair loss, pruritus, pigmentation changes. Potentially Fatal: Physical dependence and acute withdrawal reactions (prolonged use, abrupt discontinuation, or rapid dosage reduction after continued use); abuse, misuse, and addiction.
IV/Parenteral/PO: Z (Insufficient data to conclude its safety and risk during pregnancy. Neonatal adverse effects (paralytic ileus, apnea, hypotonia) have been reported. Use only when benefits outweigh risks.)
Patient Counseling Information
This drug may cause CNS depression, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor mental alertness, CBC, LFTs, and kidney function periodically during prolonged treatment. Closely monitor patients concomitantly receiving opioids for signs of respiratory depression and sedation. Assess for signs and symptoms of suicidal ideation and behaviour.
Overdosage
Symptoms: Severe somnolence with hypotonia, confusion, lethargy, drowsiness, dysarthria, nystagmus, ataxia, areflexia, apnoea, hypotension, cardiorespiratory depression, or coma.
Management: Symptomatic and supportive treatment. Maintain clear airway and adequate ventilation. Administer activated charcoal within 1-2 hours of ingestion provided that the patient is not drowsy. May perform gastric lavage in case of mixed ingestion. Flumazenil may be used for severe CNS depression; use with extreme caution, particularly in those receiving chronic therapy and medicines that decrease seizure threshold (e.g. TCAs).
Drug Interactions
Additive CNS depressant effects with other antiepileptic drugs (e.g. hydantoins), barbiturates, sedatives, TCAs, skeletal muscle relaxants, phenothiazines, antihistamines, narcotic analgesics, and anaesthetics. Decreased plasma concentration with carbamazepine, lamotrigine, valproic acid, phenobarbital, phenytoin, primidone, and theophylline. Increased risk of prolonged sedation and respiratory depression with amprenavir. Increased plasma concentration with cimetidine, disulfiram, fluvoxamine, and ritonavir. May antagonise the effect of levodopa. May enhance the hypotensive effect of alpha-blockers, ACE inhibitors, ARBs, β-blockers, calcium channel blockers, and moxonidine. Potentially Fatal: Increased risk of profound sedation, respiratory depression, and coma with opioids.
Food Interaction
Increased risk of severe sedation, respiratory or CV depression, and coma with alcohol.
Action
Description: Mechanism of Action: Clonazepam is an intermediate to long-acting benzodiazepine derivative. Its exact mechanism of action is unknown; however, it appears to be related with its ability to enhance the activity of GABA, the principal inhibitory neurotransmitter in the CNS. It also suppresses paroxysmal activity, including spike-wave discharge in absence seizures, by depressing nerve transmission in the motor cortex. Onset: Approx 20-40 minutes. Pharmacokinetics: Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: Approx 90%. Time to peak plasma concentration: 1-4 hours. Distribution: Crosses the placenta and enters breast milk. Volume of distribution: 1.5-6.4 L/kg. Plasma protein binding: Approx 85%. Metabolism: Extensively metabolised in the liver via glucuronide and sulfate conjugation; undergoes nitroreduction and acetylation by CYP3A4 to form 7-aminoclonazepam and 7-acetamidoclonazepam, respectively. Excretion: Mainly via urine ( <2% as unchanged drug); metabolites excreted as glucuronide or sulfate conjugates. Elimination half-life: 17-60 hours.
Chemical Structure
Clonazepam Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2802, Clonazepam. https://pubchem.ncbi.nlm.nih.gov/compound/Clonazepam. Accessed Sept. 30, 2025.
Storage
Oral: Conventional tab: Store below 30°C. Protect from light. Oral solution: Store below 25°C. Protect from light. Orally disintegrating tab: Store between 15-30°C.
Intravenous: Concentrated solution for inj/infusion: Store below 25°C. Protect from light.
N03AE01 - clonazepam ; Belongs to the class of benzodiazepine derivatives antiepileptic.
References
Brayfield A, Cadart C (eds). Clonazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2025.Clonazepam Auden 500 mcg Tablets (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2025.Clonazepam Rosemont 2 mg/5 mL Oral Solution (Rosemont Pharmaceuticals Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2025.Clonazepam Tablet (Accord Healthcare Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2025.Clonazepam Tablet, Orally Disintegrating (Teva Pharmaceuticals USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2025.Clonazepam XGX Pharma 1 mg/mL, Concentrate for Solution for Injection/Infusion (XGX Pharma UK Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2025.Clonazepam. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/08/2025.Clonazepam. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/08/2025.Clonotril-0.5/Clonotril-2 (Torrent Pharmaceuticals Ltd.). MIMS Philippines. http://www.mims.com/philippines. Accessed 18/08/2025.Joint Formulary Committee. Clonazepam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2025.Rivotril Tablets (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/08/2025.Roche Products (New Zealand) Limited. Rivotril 1 mg/mL Concentrated Injection Solution data sheet 11 May 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 04/08/2025.Viatris Ltd. Paxam 0.5 mg and 2 mg Tablets data sheet 2 July 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 04/08/2025.
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