clonazepam (Rx)

Brand and Other Names:Klonopin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet dispersible: Schedule IV

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 1mg
  • 2mg

tablet: Schedule IV

  • 0.5mg
  • 1mg
  • 2mg
more...

Panic Disorder

0.25 mg PO q12hr initially; may increase to 1 mg/day after 3 days (up to 4 mg/day in some patients)

Seizure Disorders

1.5 mg/day PO divided q8hr; increase by 0.5-1 mg q3Days until desired effect achieved; not to exceed 20 mg/day

Maintenance: 2-8 mg PO; not to exceed 20 mg/day  

Essential Tremor (Off-label)

0.5 mg PO at bedtime; increase dose by 0.5 mg q3-4days; not to exceed 6 mg/day

REM Sleep Behavior Disorder (Off-label)

0.25-2 mg PO 30 min prior to bedtime; not to exceed 4 mg

Burning Mouth Syndrome (Off-label)

0.25 mg PO at bedtime for 1 week; increase dose by up to 0.25 mg qweek; not to exceed 3 mg daily in 3 divided doses

Alternatively, 1 mg topirally three times daily after each meal; suck on the tablet, retain salive in mouth near pain sites without swallowing for 3 min, then expectorate saliva

Tardive Dyskinesia (Off-label)

The American Academy of Neurology guidelines includes use of clonazepam for short-term treatment (~3 mo) to decrease tardive dyskinesia symptoms

Initial: 1 mg/day PO; adjust dose based on response and tolerability by 1 mg/day increments q3-4 days; not to exceed 4.5 mg/day

Dosage Modifications

Renal impairment: Supplemental dose in hemodialysis not necessary

Dosing Considerations

Discontinuation of treatment: Withdraw treatment gradually; decrease the dose q3Days by 0.125 mg PO q12hr until completely withdrawn

Hyperekplexia (Orphan)

Orphan indication sponsor

  • Hoffmann-La Roche, Inc; 340 Kingsland Street; Nutley, NJ 07110

Recurrent, Acute, Repetitive Seizures (Orphan)

Administration: Intranasal spray

Orphan indication sponsor

  • Jazz Pharmaceuticals, Inc; 3180 Porter Drive; Palo Alto, CA 94304

Tardive Dyskinesia (Off-label)

The American Academy of Neurology guidelines includes use of clonazepam for short-term treatment (~3 mo) to decrease tardive dyskinesia symptoms

Initial: 1 mg/day PO; adjust dose based on response and tolerability by 1 mg/day increments q3-4 days; not to exceed 4.5 mg/day

Dosage Forms & Strengths

tablet: Schedule IV

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 1mg
  • 2mg
more...

Seizure Disorders

<6 years

  • Potential toxic dose: 0.05 mg/kg  

<10 years or <30 kg

  • 0.01-0.03 mg/kg/day PO divided q8hr; increase by 0.25-0.5 mg/day q3Days to maximum 0.1-0.2 mg/kg/day PO divided q8hr
  • Maintenance dose: 0.1-0.2 mg/kg/day PO divided q8hr; not to exceed 0.2 mg/kg/day

≥10 years or ≥30 kg

  • 1.5 mg/day PO divided q8hr; increase by 0.5-1 mg q3Days until desired effect achieved; not to exceed 20 mg/day
  • Maintenance: 2-8 mg PO; not to exceed 20 mg/day

Dosing Considerations

Discontinuation of treatment

  • <10 years: Treatment should be withdrawn gradually, as necessary
  • ≥10 years: Withdraw treatment gradually; decrease the dose q3Days by 0.125 mg PO q12hr until completely withdrawn
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Interactions

Interaction Checker

and clonazepam

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Somnolence (37%)

            1-10%

            Abnormal coordination (5-10%)

            Ataxia (5-10%)

            Depression (5-10%)

            Dizziness (5-10%)

            Fatigue (5-10%)

            Memory impairment (5-10%)

            Upper respiratory infection (5-10%)

            Confusion (1-5%)

            Dysarthria (1-5%)

            Rhinitis (1-5%)

            Coughing (1-5%)

            Urinary frequency (1-5%)

            Impotence (1-5%)

            Decreased libido (1-5%)

            Frequency Not Defined

            Increased salivation

            Worsening tonic-clonic seizures

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            Warnings

            Black Box Warnings

            Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation

            Contraindications

            Significant hepatic impairment

            Documented hypersensitivity

            Acute narrow angle glaucoma

            Cautions

            Withdraw gradually when used for panic disorder

            Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicidal ideation

            Not recommended in patients with depressed neuroses, psychotic reactions, severe respiratory depression, myasthenia gravis (allowable in limited circumstances), acute alcohol intoxication

            Anterograde amnesia reported benzodiazepine use

            May cause CNS depression and impairs ability to perform hazardous tasks

            Hyperactive or aggressive behavior reported with benzodiazepines in pediatric/adolescent patients and in psychiatric patients

            Increased risk of suicidal thoughts/behavior reported with antiepileptic agents; monitor patient for suicidal behavior and notify health-care provider immediately

            Use with caution in patients with a history of drug abuse or acute alcoholism; drug dependency possible; prolonged use may result in psychological and physical dependence

            Use with caution in patients with compromised respiratory function

            May have porphyrogenic effect; use with caution in patients with porphyria

            Not for concomitant administration with alcohol or other CNS-depressant drugs

            When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase incidence or precipitate onset of generalized tonic-clonic seizures (grand mal); may require addition of appropriate anticonvulsants or increase in dosages; concomitant use of valproic acid and clonazepam may produce absence status

            Abrupt withdrawal, particularly in patients on long-term, high-dose therapy, may precipitate status epilepticus; when discontinuing clonazepam, gradual withdrawal essential; while being gradually withdrawn, simultaneous substitution of another anticonvulsant may be indicated

            May produce increase in salivation; consider before giving drug to patients who have difficulty handling secretions

            In some studies, up to 30% of patients who initially responded have shown a loss of anticonvulsant activity, often within 3 months of administration; in some cases, dosage adjustment may reestablish efficacy

            Paradoxical reactions, such as agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations, and psychoses may occur when using benzodiazepines; discontinue therapy, should this occur; paradoxical reactions are more likely to occur in children and in the elderly

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies of Klonopin in pregnant women; available human data on risk of teratogenicity are inconclusive; there is insufficient evidence in humans to assess effect of benzodiazepine exposure during pregnancy on neurodevelopment; administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding; in addition, infants born to mothers who have taken benzodiazepines during later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period

            Data for other benzodiazepines suggest possibility of adverse developmental effects (long-term effects on neurobehavioral and immunological function) in animals following prenatal exposure to benzodiazepines

            Lactation

            Effects on breastfed infant and on milk production are unknown; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting benzodiazepine that increases the presynaptic GABA inhibition and reduces the monosynaptic and polysynaptic reflexes. Suppresses muscle contractions by facilitating inhibitory GABA neurotransmission and other inhibitory transmitters

            Suppresses the spike-and-wave discharge in absence seizures by depressing nerve transmission in motor cortex

            Absorption

            Bioavailability: 90%

            Onset: 20-40 min

            Peak plasma time: 1-4 hr; 5-7 days (steady state)

            Distribution

            Protein bound: 85%

            Vd: 1.5-3 L/kg

            Metabolism

            Metabolized by CYP3A4 (minor), glucuronic acid conjugation

            Metabolites: Inactive

            Elimination

            Half-life: 17-60 hr (adults); 22-33 hr (children)

            Excretion: Urine

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.