Clonazepam Monograph for Professionals - Drugs. Class: Benzodiazepines. VA Class: CN4. 00. CAS Number: 1. 62. Brands: Klonopin. Introduction. Benzodiazepine; anticonvulsant, sedative, and anxiolytic.
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Uses for Clonazepam. Seizure Disorders. Prophylactic management of Lennox- Gastaut syndrome and akinetic and myoclonic seizures.
Management of absence seizures in patients unresponsive to succinimides. Some evidence of success in the management of refractory seizures†, including partial seizures with complex symptomatology and other partial seizures and some cases of infantile spasms†. Useful in some patients with tonic- clonic seizures†. Panic Disorder. Treatment of panic disorder with or without agoraphobia.
Catatonia. Also has been used for treatment of acute catatonic reactions†, whether associated with schizophrenia or other conditions. Akathisia. May be helpful in patients experiencing akathisia† while receiving antipsychotic drugs (e. Clonazepam Dosage and Administration. General. Adjust dosage carefully and slowly according to individual requirements and response. Withdraw clonazepam slowly; avoid abrupt discontinuance, especially during long- term, high- dose therapy, to avoid precipitating seizures, status epilepticus, or withdrawal symptoms. During withdrawal of clonazepam in patients with seizure disorders, simultaneous substitution of another anticonvulsant may be indicated. Administration. Oral Administration.
Administer orally as conventional or orally disintegrating tablets. Administer in 3 equally divided doses for the treatment of seizure disorders; if doses are not equally divided, give the largest dose at bedtime. Administer in 2 equally divided doses for the management of panic disorder; alternatively, administer the entire dosage at bedtime to reduce the inconvenience of somnolence. Conventional Tablets.
Swallow tablet whole with water. Orally Disintegrating Tablets. Just prior to administration, remove blister from aluminum pouch; with dry hands, peel open blister package, place orally disintegrating tablet in mouth to dissolve, and swallow with or without water. Dosage. Pediatric Patients. Seizure Disorders.
References. Only references cited for selected revisions after 1984 are available electronically. 1. Roche Laboratories Inc. Klonopin (clonazepam) tablets prescribing information. Nutley, NJ; 1997 Oct. 2. American Psychiatric.
Oral. Infants and children < 1. Initially, 0. 0. 1–0. Increase dosage by no more than 0. Maintenance dosage of 0. Children ≥1. 0 years of age or weighing ≥3. Initial dosage should not exceed 1.
Increase dosage in increments of 0. Adults. Seizure Disorders. Oral. Initial dosage should not exceed 1.
Increase dosage in increments of 0. Panic Disorder. Oral. Initially, 0. 2. 5 mg twice daily. After 3 days, increase dosage to usual maintenance dosage of 1 mg daily.
Some clinicians recommend dosages of 1–2 mg daily. Certain patients may benefit from dosages up to 4 mg daily. In such cases, increase dosage by 0. Discontinue therapy gradually by decreasing the dosage in increments of 0. Prescribing Limits.
Pediatric Patients. Seizure Disorders. Oral. Maximum 0. 2 mg/kg daily. Adults. Seizure Disorders. Oral. Maximum 2. 0 mg daily. Panic Disorder. Oral. Maximum 4 mg daily.
Special Populations. Geriatric Patients.
Initiate therapy at low dosage and observe closely. Cautions for Clonazepam.
Contraindications. Known hypersensitivity to clonazepam or other benzodiazepines. Clinical or biochemical evidence of substantial hepatic impairment. Manufacturer states that clonazepam is contraindicated in patients with acute angle- closure glaucoma but may be administered to patients with open- angle glaucoma who are receiving appropriate therapy; 1 however, clinical rationale for this contraindication has been questioned.
Warnings/Precautions. Warnings. CNS Effects.
Performance of activities requiring mental alertness and physical coordination may be impaired. Concurrent use of other CNS depressants may potentiate CNS depression. See Specific Drugs under Interactions.)Withdrawal Effects.
Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates or alcohol). Symptoms may be relieved by tapering the dosage. General Precautions. Seizure Disorders. May increase the incidence or precipitate the onset of generalized tonic- clonic seizures in patients with multiple types of seizure disorders.
Consider addition of appropriate anticonvulsants or an increase in their dosages. Abrupt withdrawal, particularly in patients receiving long- term, high- dose therapy, may result in status epilepticus. Concomitant use with valproic acid may produce absence status. Laboratory Testing. Perform blood counts and liver function tests periodically during long- term therapy. Hypersalivation. May increase salivation; use with caution in patients who have difficulty tolerating or clearing secretions.
Respiratory Effects. Possible hypersalivation and respiratory depression in patients with chronic respiratory disease; use with caution in such patients.
Abuse Potential. Psychologic and physical dependence may occur following prolonged use. Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients. Suicide. Use with caution in depressed patients; potential for suicidal tendencies. Prescribe drug in the smallest feasible quantity. Psychiatric Indications. Do not use in patients with depressive neuroses or psychotic reactions in which anxiety is not prominent.
Specific Populations. Pregnancy. Category D.
Lactation. Distributed into milk; c discontinue nursing or the drug. Pediatric Use. Effects of long- term administration on physical and mental development have not been established. Administer to children with seizure disorders only if potential benefits outweigh possible risks.
Safety and efficacy for treatment of panic disorder not established in children < 1. Geriatric Use. Insufficient experience from clinical studies to determine whether patients ≥6.
Other clinical experience has not identified age- related differences in responses. Potential increased sensitivity (increased risk of oversedation and confusion) to sedatives. Select dosage carefully, generally initiating therapy at low dosage; observe closely. Consider the increased incidence of hepatic and renal impairment, decreased cardiac function, and concomitant disease and drug therapy in the geriatric population. May be useful to assess hepatic and/or renal function when selecting dosage.
Hepatic Impairment. Prolonged elimination. Contraindicated in patients with clinical or biochemical evidence of substantial liver disease. Renal Impairment. Elimination of metabolites may be decreased; use with caution. Common Adverse Effects.
Sedation/drowsiness, ataxia/hypotonia, behavioral disturbances (principally in children) including aggressiveness, irritability, agitation, hyperkinesis. Interactions for Clonazepam. Metabolized by CYP enzymes, including CYP3. A. 1. Drugs Affecting or Affected by Hepatic Microsomal Enzymes. Potential pharmacokinetic interaction (altered plasma concentrations of clonazepam) with CYP inducers or inhibitors.
No evidence that clonazepam induces metabolism of other drugs. Specific Drugs. Drug. Interaction. Comments.
Antifungal agents, azole- type (e. Possible increase in plasma clonazepam concentrationsa. Use with caution.
Carbamazepine. Decreased plasma clonazepam concentrations; carbamazepine pharmacokinetics not affecteda. CNS depressants (e. Additive CNS effects. Use caution to avoid overdosageb. Disulfiram. Possible increase in plasma clonazepam concentrations. Reduce clonazepam dosage as necessary.
Fluoxetine. Clonazepam pharmacokinetics not affecteda. Phenobarbital. Decreased plasma clonazepam concentrations; phenobarbital pharmacokinetics not affecteda. Phenytoin. Decreased plasma clonazepam concentrations; phenytoin pharmacokinetics not affecteda. Propantheline. Possible decrease in plasma clonazepam concentrationsa. Clonazepam Pharmacokinetics. Absorption. Bioavailability.
Rapidly and completely absorbed following oral administration, with peak concentrations achieved within 1–4 hours. Absolute bioavailability is approximately 9. Onset. Anticonvulsant action occurs within 2.
Duration. Duration of anticonvulsant action is 6–8 hours in infants and young children and up to 1. Distribution. Extent. Apparently crosses the blood- brain barrier and the placenta. Plasma Protein Binding.
Approximately 8. 5%. Elimination. Metabolism. Extensively metabolized in the liver to several metabolites. Elimination Route. Excreted in urine (< 2% as unchanged drug).
Half- life. 18–5. Stability. Storage. Oral. Conventional or Orally Disintegrating Tablets. C (may be exposed to 1. C). a. Actions. Exact mechanism of anticonvulsant, sedative, and antipanic effects is unknown; 1 however, mechanism appears to be related to the drug’s ability to enhance the activity of GABA, the principal inhibitory neurotransmitter in the CNS. Advice to Patients.
Importance of taking only as prescribed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician. Importance of not abruptly discontinuing therapy; consult clinician about discontinuing use. Potential for psychologic or physiologic dependence. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, particularly depression.
Importance of avoiding alcohol- containing beverages or products. Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known. Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast- feed.
Importance of informing patients of other important precautionary information. See Cautions.)Preparations. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
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