Klonopin

— 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

    • Klonopin Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clonazepam 0.5mg+, 1mg, 2mg; tabs; +scored.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs—100; Orally-disintegrating tabs—contact supplier

    How Supplied

    Klonopin tablets are available as scored tablets with a K-shaped perforation—0.5 mg, orange; and unscored tablets with a K-shaped perforation—1 mg, blue; 2 mg, white—bottles of 100.

    Storage

    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

    Manufacturer

    H2 Pharma, LLC

    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.

    Klonopin Indications

    Indications

    Panic disorder.

    Klonopin 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.

    Klonopin Contraindications

    Contraindications

    Significant liver disease. Acute narrow-angle glaucoma.

    Klonopin Boxed Warnings

    Boxed Warning

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

    Boxed Warning

    Risks from Concomitant Use with Opioids

    • Risk of profound sedation, respiratory depression, coma and death with opioids.

    • Reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required. Monitor for signs and symptoms of respiratory depression and sedation. 

    Abuse, Misuse, and Addiction

    • Risk of abuse, misuse, and addiction, that can potentially lead to overdose and death. Prior to initiating treatment, evaluate the risk for each patient and monitor regularly during treatment for the development of any addiction, abuse, and misuse.

    Dependence and Withdrawal Reactions

    • Continued use may lead to clinically significant physical dependence.

    • Increased risk for dependence and withdrawal with longer treatment duration and higher daily dose.

    • Abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions. 

    • Gradually taper to discontinue or reduce dose to reduce the risk for withdrawal reactions.

    Klonopin 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.

    Warnings/Precautions

    Risks from Concomitant Use with Opioids

    • Increased sedation, respiratory depression, coma, and death with concomitant opioids. Because of these risks, reserve use in those for whom alternative treatment options are inadequate. 

    • If concomitant use with opioids is needed, limit dosages/durations to minimum and monitor patients closely for signs and symptoms of respiratory depression and sedation. 

    • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined.

    Abuse, Misuse, and Addiction

    • Risks for abuse, misuse, and addiction that can potentially lead to overdose or death.

    • Assess patient's risk for abuse, misuse, addiction prior to and during therapy. 

    • Prescribe the lowest effective dosage. Avoid or minimize concomitant use of CNS depressants and other substances associated with these risks.

    • Evaluate and institute early treatment if substance use disorder is suspected.

    Dependence and Withdrawal Reactions

    • Gradually taper to discontinue or reduce dose. Increased risk for withdrawal adverse reactions in patients who take higher doses and those with longer durations of use.

    • Acute Withdrawal Reactions: Abrupt discontinuation or rapid dose reduction after continued use, or administration of flumazenil may cause acute withdrawal reactions.

    • Protracted Withdrawal Syndrome: In some cases, this syndrome has lasted weeks to more than 12 months. Pre-existing depression may emerge or worsen during treatment. Do not use in patients with a primary depressive disorder or psychosis. 

    Interference with Cognitive and Motor Performance

    • Caution against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. Warn against the concomitant use of alcohol or other CNS-depressant drugs during Klonopin therapy.

    Suicidal Behavior and Ideation

    • Increased risk of suicidal thoughts or behavior in patients taking AEDs, including Klonopin. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    • Weigh the risk of suicidal thoughts or behavior when consider prescribing Klonopin or any other AED.

    Neonatal Sedation and Withdrawal Syndrome

    • Use late in pregnancy can cause sedation and/or withdrawal symptoms in the neonate. Monitor neonates exposed during pregnancy or labor for signs of sedation and monitor for signs of withdrawal.

    General

    • Klonopin may increase the incidence or worsen the onset of generalized tonic-clonic seizures (grand mal) when used in patients with several different types of seizure disorders coexist. Concomitant use of valproic acid and Klonopin may result in absence status.

    • In certain studies, up to 30% of patients who initially responded have shown a loss of anticonvulsant activity, often within 3 months of administration.

    • Obtain periodic blood counts and liver function tests during long-term therapy with Klonopin.

    • Paradoxical reactions may occur, especially in children and elderly.

    • Caution in patients with renal impairment. 

    • Klonopin may increase salivation; use caution in patients with difficulty handling secretions.

    • Caution in patients with compromised respiratory function (eg, COPD, sleep apnea).

    • Caution in patients with porphyria.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy registry that monitors pregnancy outcomes in women exposed to AEDs, including Klonopin, during pregnancy. Healthcare providers are encouraged to register patients by enrolling in the NAAED Pregnancy Registry by calling  1-888-233-2334 or visiting online at http://www.aedpregnancyregistry.org/. 

    Risk Summary

    • Neonates born to mothers using benzodiazepines late in pregnancy have reported to experience symptoms of sedation and/or neonatal withdrawal. 

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Klonopin during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Klonopin during pregnancy for signs of withdrawal.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Klonopin and any potential adverse effects on the breastfed infant from Klonopin or from the underlying maternal condition.  

    Clinical Considerations 

    • Monitor infants exposed to Klonopin for sedation, poor feeding and poor weight gain.

    Pediatric Considerations

    Safety and efficacy of Klonopin in pediatric patients less than 18 years of age has not been established.

    Geriatric Considerations

    In general, use caution when selecting dosage for an elderly patient.

    Klonopin 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. 

    Klonopin 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.

    Klonopin 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.

    Klonopin Clinical Trials

    See Literature

    Klonopin Note

    Not Applicable

    Klonopin Patient Counseling

    Patient Counseling

    Risks from Concomitant Use with Opioids

    • Increased risk of fatal additive effects with concomitant opioids. Advise patients not to use such drugs concomitantly unless supervised by a health care provider. 

    Abuse, Misuse, and Addiction

    • Advise patients that Klonopin, even at recommended dosages, can lead to a risk of abuse, misuse, and addiction that can result in overdose and death especially when used with other medications (eg, opioids), alcohol, and/or illicit substances.

    • Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction. Seek help if they develop these signs and/or symptoms.

    Withdrawal Reactions

    • Gradually taper to discontinue Klonopin or reduce dose. Increased risk for acute withdrawal adverse reactions in patients who abruptly discontinued or rapidly reduced the dose.

    • Inform patients that in some cases, protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months have occurred in patients taking benzodiazepines.

    Interference with Cognitive and Motor Performance

    • Use caution if operating hazardous machinery, including automobiles, until they are reasonably certain Klonopin therapy does not affect them adversely.

    Suicidal Thinking and Behavior

    • Counsel patients, caregivers, and families that AEDs, including Klonopin, may increase the risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

    Pregnancy

    • The use of Klonopin late in pregnancy can cause sedation and/or withdrawal symptoms in newborns. Advise patients that there is a pregnancy exposure registry.

    Nursing

    • Notify your healthcare provider if you are breastfeeding or intend to breastfeed.

    • Advise breastfeeding patients taking Klonopin to monitor infants for excessive sedation, poor feeding and poor weight gain.

    Concomitant Medication

    • Inform your physician if you are taking, or plan to take, any prescription or over-the-counter drugs, since there is potential for interactions.

    Alcohol

    • Advise patients to avoid alcohol while taking Klonopin.

    Klonopin Generic Name & Formulations

    Legal Class

    CIV

    General Description

    Clonazepam 0.5mg+, 1mg, 2mg; tabs; +scored.

    Pharmacological Class

    Benzodiazepine.

    See Also

    How Supplied

    Tabs—100; Orally-disintegrating tabs—contact supplier

    How Supplied

    Klonopin tablets are available as scored tablets with a K-shaped perforation—0.5 mg, orange; and unscored tablets with a K-shaped perforation—1 mg, blue; 2 mg, white—bottles of 100.

    Storage

    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

    Manufacturer

    H2 Pharma, LLC

    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.

    Klonopin Indications

    Indications

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

    Klonopin 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.

    Klonopin Contraindications

    Contraindications

    Significant liver disease. Acute narrow-angle glaucoma.

    Klonopin Boxed Warnings

    Boxed Warning

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

    Boxed Warning

    Risks from Concomitant Use with Opioids

    • Risk of profound sedation, respiratory depression, coma and death with opioids.

    • Reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required. Monitor for signs and symptoms of respiratory depression and sedation. 

    Abuse, Misuse, and Addiction

    • Risk of abuse, misuse, and addiction, that can potentially lead to overdose and death. Prior to initiating treatment, evaluate the risk for each patient and monitor regularly during treatment for the development of any addiction, abuse, and misuse.

    Dependence and Withdrawal Reactions

    • Continued use may lead to clinically significant physical dependence.

    • Increased risk for dependence and withdrawal with longer treatment duration and higher daily dose.

    • Abrupt discontinuation or rapid dose reduction may lead to acute withdrawal reactions. 

    • Gradually taper to discontinue or reduce dose to reduce the risk for withdrawal reactions.

    Klonopin 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.

    Warnings/Precautions

    Risks from Concomitant Use with Opioids

    • Increased sedation, respiratory depression, coma, and death with concomitant opioids. Because of these risks, reserve use in those for whom alternative treatment options are inadequate. 

    • If concomitant use with opioids is needed, limit dosages/durations to minimum and monitor patients closely for signs and symptoms of respiratory depression and sedation. 

    • Advise patients not to drive or operate heavy machinery until the effects of concomitant use with opioids have been determined.

    Abuse, Misuse, and Addiction

    • Risks for abuse, misuse, and addiction that can potentially lead to overdose or death.

    • Assess patient's risk for abuse, misuse, addiction prior to and during therapy. 

    • Prescribe the lowest effective dosage. Avoid or minimize concomitant use of CNS depressants and other substances associated with these risks.

    • Evaluate and institute early treatment if substance use disorder is suspected.

    Dependence and Withdrawal Reactions

    • Gradually taper to discontinue or reduce dose. Increased risk for withdrawal adverse reactions in patients who take higher doses and those with longer durations of use.

    • Acute Withdrawal Reactions: Abrupt discontinuation or rapid dose reduction after continued use, or administration of flumazenil may cause acute withdrawal reactions.

    • Protracted Withdrawal Syndrome: In some cases, this syndrome has lasted weeks to more than 12 months. Pre-existing depression may emerge or worsen during treatment. Do not use in patients with a primary depressive disorder or psychosis. 

    Interference with Cognitive and Motor Performance

    • Caution against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. Warn against the concomitant use of alcohol or other CNS-depressant drugs during Klonopin therapy.

    Suicidal Behavior and Ideation

    • Increased risk of suicidal thoughts or behavior in patients taking AEDs, including Klonopin. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

    • Weigh the risk of suicidal thoughts or behavior when consider prescribing Klonopin or any other AED.

    Neonatal Sedation and Withdrawal Syndrome

    • Use late in pregnancy can cause sedation and/or withdrawal symptoms in the neonate. Monitor neonates exposed during pregnancy or labor for signs of sedation and monitor for signs of withdrawal.

    General

    • Klonopin may increase the incidence or worsen the onset of generalized tonic-clonic seizures (grand mal) when used in patients with several different types of seizure disorders coexist. Concomitant use of valproic acid and Klonopin may result in absence status.

    • In certain studies, up to 30% of patients who initially responded have shown a loss of anticonvulsant activity, often within 3 months of administration.

    • Obtain periodic blood counts and liver function tests during long-term therapy with Klonopin.

    • Paradoxical reactions may occur, especially in children and elderly.

    • Caution in patients with renal impairment. 

    • Klonopin may increase salivation; use caution in patients with difficulty handling secretions.

    • Caution in patients with compromised respiratory function (eg, COPD, sleep apnea).

    • Caution in patients with porphyria.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    • There is a pregnancy registry that monitors pregnancy outcomes in women exposed to AEDs, including Klonopin, during pregnancy. Healthcare providers are encouraged to register patients by enrolling in the NAAED Pregnancy Registry by calling  1-888-233-2334 or visiting online at http://www.aedpregnancyregistry.org/. 

    Risk Summary

    • Neonates born to mothers using benzodiazepines late in pregnancy have reported to experience symptoms of sedation and/or neonatal withdrawal. 

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to Klonopin during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to Klonopin during pregnancy for signs of withdrawal.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Klonopin and any potential adverse effects on the breastfed infant from Klonopin or from the underlying maternal condition.  

    Clinical Considerations 

    • Monitor infants exposed to Klonopin for sedation, poor feeding and poor weight gain.

    Pediatric Considerations

    Safety and efficacy of Klonopin in pediatric patients less than 18 years of age has not been established.

    Geriatric Considerations

    In general, use caution when selecting dosage for an elderly patient.

    Klonopin 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. 

    Klonopin 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.

    Klonopin 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.

    Klonopin Clinical Trials

    See Literature

    Klonopin Note

    Not Applicable

    Klonopin Patient Counseling

    Patient Counseling

    Risks from Concomitant Use with Opioids

    • Increased risk of fatal additive effects with concomitant opioids. Advise patients not to use such drugs concomitantly unless supervised by a health care provider. 

    Abuse, Misuse, and Addiction

    • Advise patients that Klonopin, even at recommended dosages, can lead to a risk of abuse, misuse, and addiction that can result in overdose and death especially when used with other medications (eg, opioids), alcohol, and/or illicit substances.

    • Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction. Seek help if they develop these signs and/or symptoms.

    Withdrawal Reactions

    • Gradually taper to discontinue Klonopin or reduce dose. Increased risk for acute withdrawal adverse reactions in patients who abruptly discontinued or rapidly reduced the dose.

    • Inform patients that in some cases, protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months have occurred in patients taking benzodiazepines.

    Interference with Cognitive and Motor Performance

    • Use caution if operating hazardous machinery, including automobiles, until they are reasonably certain Klonopin therapy does not affect them adversely.

    Suicidal Thinking and Behavior

    • Counsel patients, caregivers, and families that AEDs, including Klonopin, may increase the risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

    Pregnancy

    • The use of Klonopin late in pregnancy can cause sedation and/or withdrawal symptoms in newborns. Advise patients that there is a pregnancy exposure registry.

    Nursing

    • Notify your healthcare provider if you are breastfeeding or intend to breastfeed.

    • Advise breastfeeding patients taking Klonopin to monitor infants for excessive sedation, poor feeding and poor weight gain.

    Concomitant Medication

    • Inform your physician if you are taking, or plan to take, any prescription or over-the-counter drugs, since there is potential for interactions.

    Alcohol

    • Advise patients to avoid alcohol while taking Klonopin.

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