Clonazepam Orally-disintegrating Tabs

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
  • Seizure disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Clonazepam Orally-disintegrating Tabs Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clonazepam 0.125mg, 0.25mg, 0.5mg, 1mg, 2mg; orally-disintegrating tabs.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs—100; Orally-disintegrating tabs—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.

    Clonazepam Orally-disintegrating Tabs Indications

    Indications

    Panic disorder.

    Clonazepam Orally-disintegrating Tabs Dosage and Administration

    Adult

    ≥18yrs: initially 0.25mg twice daily; after 3 days increase to 1mg/day; then may increase every 3 days by 0.125–0.25mg twice daily; max 4mg/day. Orally-disintegrating tabs: dissolve in mouth; swallow with or without water.

    Children

    <18yrs: not established.

    Clonazepam Orally-disintegrating Tabs Contraindications

    Contraindications

    Significant liver disease. Acute narrow-angle glaucoma.

    Clonazepam Orally-disintegrating Tabs Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Clonazepam Orally-disintegrating Tabs Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Suicidal thoughts or behavior (monitor). Depression. May increase or precipitate tonic-clonic seizures. Compromised respiratory function (eg, COPD, sleep apnea). Porphyria. Monitor LFTs, CBCs during long-term therapy. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Renal impairment. Elderly. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

    Clonazepam Orally-disintegrating Tabs Pharmacokinetics

    Absorption

    Absolute bioavailability: ~90%. Maximum plasma concentrations reached within 1 to 4 hours after oral administration.

    Distribution

    Plasma protein bound: ~85%.

    Metabolism

    Hepatic (CYP3A).

    Elimination

    Renal. Half-life: 30 to 40 hours. 

    Clonazepam Orally-disintegrating Tabs Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants. Adjust anticonvulsants if needed. Absence seizures with valproate. Caution with drugs that inhibit CYP3A4 (eg, fluconazole). Antagonized by CYP450 inducers (eg, phenytoin, carbamazepine, lamotrigine, phenobarbital); monitor.

    Clonazepam Orally-disintegrating Tabs Adverse Reactions

    Adverse Reactions

    CNS effects (eg, somnolence, depression), confusion, amnesia, liver disorders, GI upset, blood dyscrasias, paradoxical reactions (discontinue gradually if occur); hypersalivation, withdrawal reactions.

    Clonazepam Orally-disintegrating Tabs Clinical Trials

    See Literature

    Clonazepam Orally-disintegrating Tabs Note

    Not Applicable

    Clonazepam Orally-disintegrating Tabs Patient Counseling

    See Literature

    Clonazepam Orally-disintegrating Tabs Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clonazepam 0.125mg, 0.25mg, 0.5mg, 1mg, 2mg; orally-disintegrating tabs.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs—100; Orally-disintegrating tabs—contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.

    Clonazepam Orally-disintegrating Tabs Indications

    Indications

    Lennox-Gastaut syndrome, akinetic and myoclonic seizures. Absence seizures refractory to succinimides.

    Clonazepam Orally-disintegrating Tabs Dosage and Administration

    Adult

    Initially up to 0.5mg 3 times daily. Increase if needed every 3 days by 0.5–1mg daily; max 20mg daily. Orally-disintegrating tabs: dissolve in mouth; swallow with or without water.

    Children

    ≤10yrs or ≤30kg: initially 0.01–0.03mg/kg per day, but not >0.05mg/kg per day in 2–3 divided doses. Increase if needed every 3 days by 0.25–0.5mg daily. Maintenance: 0.1–0.2mg/kg per day in 3 equally divided doses. Orally-disintegrating tabs: dissolve in mouth; swallow with or without water.

    Clonazepam Orally-disintegrating Tabs Contraindications

    Contraindications

    Significant liver disease. Acute narrow-angle glaucoma.

    Clonazepam Orally-disintegrating Tabs Boxed Warnings

    Boxed Warning

    Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

    Clonazepam Orally-disintegrating Tabs Warnings/Precautions

    Warnings/Precautions

    Increased risk of drug-related mortality from concomitant use with opioids. Suicidal thoughts or behavior (monitor). Depression. May increase or precipitate tonic-clonic seizures. Compromised respiratory function (eg, COPD, sleep apnea). Porphyria. Monitor LFTs, CBCs during long-term therapy. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Renal impairment. Elderly. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

    Clonazepam Orally-disintegrating Tabs Pharmacokinetics

    Absorption

    Absolute bioavailability: ~90%. Maximum plasma concentrations reached within 1 to 4 hours after oral administration.

    Distribution

    Plasma protein bound: ~85%.

    Metabolism

    Hepatic (CYP3A).

    Elimination

    Renal. Half-life: 30 to 40 hours. 

    Clonazepam Orally-disintegrating Tabs Interactions

    Interactions

    Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol, other CNS depressants. Adjust anticonvulsants if needed. Absence seizures with valproate. Caution with drugs that inhibit CYP3A4 (eg, fluconazole). Antagonized by CYP450 inducers (eg, phenytoin, carbamazepine, lamotrigine, phenobarbital); monitor.

    Clonazepam Orally-disintegrating Tabs Adverse Reactions

    Adverse Reactions

    CNS effects (eg, somnolence, depression), confusion, amnesia, liver disorders, GI upset, blood dyscrasias, paradoxical reactions (discontinue gradually if occur); hypersalivation, withdrawal reactions.

    Clonazepam Orally-disintegrating Tabs Clinical Trials

    See Literature

    Clonazepam Orally-disintegrating Tabs Note

    Not Applicable

    Clonazepam Orally-disintegrating Tabs Patient Counseling

    See Literature

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