CLONAZEPAM 2mg. Tablets.
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Description
Clonazepam 2mg.
BOXED WARNING
As with other benzodiazepines, clonazepam should be used with extreme caution in patients with pulmonary disease or conditions associated with compromised respiratory function such as sleep apnea, bronchitis, pneumonia, asthma, or chronic obstructive pulmonary disease (COPD). Additionally, avoid coadministration with other CNS depressants, especially opioids, unless no other alternatives are available as coadministration significantly increases the risk for respiratory depression, low blood pressure, and death. If coadministration is necessary, follow patients for signs and symptoms of respiratory depression and sedation. Clonazepam should not be used in patients with preexisting respiratory depression, cases of shock, or coma because the drug can worsen respiratory and CNS depression. In patients who snore regularly, partial airway obstruction may convert to obstructive sleep apnea with benzodiazepine administration. Clonazepam may produce hypersalivation and may aggravate conditions in which patients have difficulty handling secretions.
DEA CLASS
Rx, schedule IV
DESCRIPTION
Oral long-acting benzodiazepine
Noticeable efficacy in the treatment of absence, petit mal variant (Lennox-Gastaut syndrome), and akinetic and myoclonic seizures, but ineffective for tonic-clonic seizures
Also used for panic disorder and restless leg syndrome.
COMMON BRAND NAMES
Ceberclon, Klonopin
HOW SUPPLIED
Ceberclon/Clonazepam/Klonopin Oral Tab: 0.5mg, 1mg, 2mg
Clonazepam/Klonopin Oral Tab Orally Dis: 0.125mg, 0.25mg, 0.5mg, 1mg, 2mg
DOSAGE & INDICATIONS
Initially, 1.5 mg/day PO, divided into 3 equal doses. This dosage may be increased by 0.5 to 1 mg every 3 days until seizures are controlled. Maximum dosage of 20 mg/day PO. The typical maintenance dose range is 2 to 8 mg/day.
See adult dosage; may require lower initial dosages and/or slower dosage titration.
Initially, 0.01 to 0.03 mg/kg/day PO (not to exceed 0.05 mg/kg/day), given in 3 equally divided doses. Increase dosage by not more than 0.25 to 0.5 mg every 3rd day to a maximum maintenance dosage of 0.1 to 0.2 mg/kg/day PO administered in 3 divided doses until seizures are controlled or adverse reactions limit further increase. Whenever possible, the daily dose should be divided into 3 equal doses. If doses are not equally divided, the largest dose should be given before retiring.
0.25 mg PO twice daily initially, increasing to 1 mg/day after 3 days in most patients. Higher doses per day are associated with more adverse effects. However, some individual patients may benefit from titration, and in those instances, may increase by 0.125 to 0.25 mg twice daily every 3 days until panic disorder is controlled or until intolerance occurs. Max: 4 mg/day PO. If discontinuation becomes necessary, gradually decrease by 0.125 mg twice daily every 3 days.
Initiate treatment with a low adult dose and monitor closely. The elderly may be more sensitive to the effects of benzodiazepines. The initial dose in younger adults is 0.25 mg PO twice daily, increasing to 1 mg/day after 3 days in most patients. Some individual patients may benefit from higher doses, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg twice daily every 3 days until panic disorder is controlled or until side effects make further increases undesired. Max adult dose: 4 mg/day PO. If discontinuation becomes necessary, gradually decrease by 0.125 mg twice daily every 3 days. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of anxiolytics in long-term care facility (LTCF) residents. Max: 1.5 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. In addition, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.
Dosage not established. Clonazepam use cannot be routinely recommended. Clonazepam appears to be effective for maintaining sleep, but efficacy in treating the primary symptoms of restless legs syndrome has not been established. Doses of 0.5 mg PO at bedtime up to 0.5 mg PO 3 times daily have not shown benefit in treating the primary symptoms of restless legs syndrome.
Doses of 0.25 to 0.5 mg PO at bedtime have been suggested.
Doses of 0.25 to 0.5 mg PO at bedtime have been suggested for younger adults. Initiate treatment with half of the adult starting dose; the elderly are more sensitive to the effects of benzodiazepines. However, clonazepam should be avoided in the elderly if possible due to its long half-life and the availability of safer alternatives.
Optimal dosage not established; individualize based on clinical response and tolerance and use lowest effective dose. A single test dose helps determine response prior to maintenance treatment; the test dose will significantly reduce or alleviate symptoms in responders, such as oscillopsia. One uncontrolled case series (n = 5) of patients with idiopathic downbeat nystagmus used a 0.5 mg PO single test dose, followed by an electronystagmography (ENG) exam 1 hour later to assess response. Maintenance treatment with 1 mg PO twice daily was given to responders; clonazepam significantly reduced but did not permanently eliminate the nystagmus. Another case series (n = 10) suggests a 1 mg PO single test dose initially and ENG exam 1 hour later. Individualized maintenance doses (range: 0.25 mg to 2 mg per dose PO) were used, with administration times tailored to daily activity. Most received 0.25 mg to 1 mg PO twice daily. A review suggests the usual labeled doses for clonazepam (e.g., 0.5 mg PO 3 times daily initially, followed by dose titration by 0.5 to 1 mg PO every 3 days, not to exceed 20 mg/day PO).
†Indicates off-label use
MAXIMUM DOSAGE
20 mg/day PO.
20 mg/day PO.
> 30 kg: 20 mg/day PO for seizures; safety and efficacy have not been established for panic disorder.
<= 30 kg: 0.1—0.2 mg/kg/day PO for seizures; safety and efficacy have not been established for panic disorder.
0.1—0.2 mg/kg/day PO for seizures; safe and effective use not established for panic disorder.
0.1—0.2 mg/kg/day PO for seizures.
DOSING CONSIDERATIONS
Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available. Clonazepam undergoes hepatic metabolism, and it is possible that liver disease will impair clonazepam elimination. The drug should not be used in patients with significant liver disease.
Dosage should be modified depending on clinical response and degree of renal impairment due to the fact that clonazepam metabolites are renally excreted, but no quantitative recommendations are available.
ADMINISTRATION
A MedGuide that discusses the risk of suicidal thoughts and behaviors associated with the use of anticonvulsant medications is available.
Clonazepam may be administered orally without regard to meals.
Conventional oral tablets: should be swallowed whole with a glass of water.
Orally disintegrating tablets (wafer): Open the pouch by peeling back the foil on the blister pack. Do not push the tablet through the foil. Using dry hands, immediately remove the tablet and place in mouth. Tablet disintegration occurs rapidly and the dissolved tablet can be swallowed with or without water.
STORAGE
Ceberclon :
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Klonopin:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Clonazepam is contraindicated in any patient with a known or suspected hypersensitivity to clonazepam, other benzodiazepine hypersensitivity, or with sensitivity to any component of the formulation.
In January 2008, the FDA alerted healthcare professionals of an increased risk of suicidal ideation and behavior in patients receiving anticonvulsants such as clonazepam to treat epilepsy, psychiatric disorders, or other conditions (e.g., migraine, neuropathic pain). This alert followed an initial request by the FDA in March 2005 for manufacturers of marketed anticonvulsants to provide data from existing controlled clinical trials for analysis. Prior to this request, preliminary evidence had suggested a possible link between anticonvulsant use and suicidality. The primary analysis consisted of 199 placebo-controlled clinical studies with a total of 27,863 patients in drug treatment groups and 16,029 patients in placebo groups (>= 5 years of age). There were 4 completed suicides among patients in drug treatment groups versus none in the placebo groups. Patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation (0.43%) as patients receiving placebo (0.24%), corresponding to an estimated 2.1 per 1000 (95% CI: 0.7—4.2) more patients in the drug treatment groups who experienced suicidal behavior or ideation. The relative risk for suicidality was higher in patients with epilepsy compared to those with other conditions; however, the absolute risk differences were similar in trials for epilepsy and psychiatric indications. Age was not a determining factor. The increased risk of suicidal ideation and behavior was observed between 1 and 24 weeks after therapy initiation. However, a longer duration of therapy should not preclude the possibility of an association to the drug since most studies included in the analysis did not continue beyond 24 weeks. Data were analyzed from drugs with adequately designed clinical trials including carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide. However, this is considered to be a class effect. All patients beginning treatment with anticonvulsants or currently receiving such treatment should be closely monitored for emerging or worsening depression or suicidal thoughts/behavior. Patients and caregivers should be informed of the increased risk of suicidal thoughts and behaviors and should be advised to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior. Anticonvulsants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.
Clonazepam should be used cautiously in patients with bipolar disorder because mania and hypomania have been reported in conjunction with the use of benzodiazepines in mood disorders.
As with other benzodiazepines, clonazepam should be used with extreme caution in patients with pulmonary disease or conditions associated with compromised respiratory function such as sleep apnea, bronchitis, pneumonia, asthma, or chronic obstructive pulmonary disease (COPD). Additionally, avoid coadministration with other CNS depressants, especially opioids, unless no other alternatives are available as coadministration significantly increases the risk for respiratory depression, low blood pressure, and death. If coadministration is necessary, follow patients for signs and symptoms of respiratory depression and sedation. Clonazepam should not be used in patients with preexisting respiratory depression, cases of shock, or coma because the drug can worsen respiratory and CNS depression. In patients who snore regularly, partial airway obstruction may convert to obstructive sleep apnea with benzodiazepine administration. Clonazepam may produce hypersalivation and may aggravate conditions in which patients have difficulty handling secretions.
Due to CNS depression, patients should be cautioned against driving or operating machinery until they know how clonazepam may affect them. Some patients may experience excessive sedation and impaired ability to perform tasks. Increased CNS effects may be seen with use of clonazepam in patients with acute ethanol intoxication or psychosis. Patients with ethanol intoxication who have also consumed clonazepam have an increased risk of respiratory suppression and coma.
Clonazepam should be used with caution in patients with a neuromuscular disease, such as muscular dystrophy, myotonia, or myasthenia gravis as these conditions can be exacerbated. Patients with late stage Parkinson’s disease may experience worsening of their psychosis or impaired cognition with administration of benzodiazepines. Benzodiazepines may also cause incoordination or paradoxical reactions that may worsen symptoms of Parkinson’s disease. Clonazepam may infrequently increase the risk for hypersalivation and should be used cautiously in patients with Parkinson’s disease.
When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. The addition of appropriate anticonvulsants or an increase in their dosages may be indicated. The concomitant use of valproic acid and clonazepam may produce absence status. Patients with a history of a seizure disorder should not be withdrawn abruptly from benzodiazepines due to the risk of precipitating a seizure. Flumazenil should not be used to reverse the actions of clonazepam in epileptic patients due to the risk of precipitating a seizure.
Clonazepam can cause physical and psychological dependence, and should be used with extreme caution in patients with known, suspected, or history of substance abuse. Tolerance (or tachyphylaxis) may develop to the sedative effects of benzodiazepines. Loss of anticonvulsant activity has been reported in up to 30% of patients who initially respond to treatment, often within the first 3 months of administration. Dosage adjustment may reestablish efficacy, in some cases. Abrupt discontinuation of clonazepam after prolonged use should be avoided. Abrupt discontinuation of benzodiazepine therapy has been reported to cause withdrawal symptoms and status epilepticus, especially following high dose or prolonged therapy. However, benzodiazepine dependence can occur following administration of therapeutic doses for as few as 1 to 2 weeks, and withdrawal symptoms may be seen following the discontinuation of therapy. Patients with a seizure history or who are taking other drugs that lower the seizure threshold (i.e., TCAs, phenothiazines) should not be withdrawn abruptly from benzodiazepines due to the risk of precipitating a seizure. Clonazepam should be withdrawn slowly, using a gradual dosage-tapering schedule. During benzodiazepine withdrawal in general, the greatest risk of seizure appears to be during the first 24 to 72 hours. When clonazepam is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated.
Clonazepam is contraindicated in patients with clinical or biochemical evidence of significant hepatic disease, as the drug undergoes hepatic metabolism.
Metabolites of clonazepam are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with renal impairment or renal failure. In general, initial dose selection should be in the lower range and dosage titration should proceed cautiously. Assess renal function during prolonged therapy and adjust dosage as clinically indicated.
Clonazepam is contraindicated in patients with acute closed-angle glaucoma. Clonazepam may be used in patients with open angle glaucoma who are receiving appropriate therapy.
Clonazepam may have a porphyrogenic effect and should be used cautiously in patients with porphyria.
Clinical studies of clonazepam did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects. Reported clinical experience has not identified differences in responses between geriatric and younger adults. Sedatives may be associated with falls, confusion and over-sedation in the older adult. Due to its long half-life and the availability of safer alternatives, clonazepam is not a preferred benzodiazepine for the treatment of insomnia in the elderly, and its use for this purpose should generally be avoided. If treatment with clonazepam is necessary in a geriatric patient, initiate treatment with a low dose followed by slow titration and close observation. Because geriatric patients are more likely to have decreased hepatic and/or renal function, care should be taken in clonazepam dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection. According to the Beers Criteria, benzodiazepines are considered potentially inappropriate medications (PIMs) for use in geriatric patients and avoidance is generally recommended, although some agents from this class may be appropriate for seizure disorders, rapid eye movement sleep disorders, benzodiazepine withdrawal, severe generalized anxiety disorder, peri-procedural anesthesia, and end of life care. Older adults have an increased sensitivity to benzodiazepines and slower metabolism of long-acting agents, which increases their risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents. The Panel recommends avoiding benzodiazepines in geriatric patients with the following disease states or symptoms due to the potential for exacerbation of the condition or increased risk of adverse effects: delirium (possible new-onset or worsening delirium), dementia (adverse CNS effects), and history of falls/fractures (ataxia, impaired psychomotor function, syncope, and additional falls). If a benzodiazepine must be used in a patient with a history of falls or fractures, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). Specific criteria for anxiolytics must be met, including 1) limiting use to indications specified in the OBRA guidelines (e.g., generalized anxiety disorder, panic disorder, significant anxiety to a situational trigger, alcohol withdrawal) which meet the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for the indication, and 2) evidence exists that other possible reasons for the individual’s distress have been considered, and 3) use results in maintenance or improvement in mental, physical, and psychosocial well-being as reflected on the Minimum Data Set (MDS) or other assessment tool. Anxiolytics should be used for delirium, dementia, or other cognitive disorders only when there are associated behaviors that are 1) quantitatively and objectively documented, and 2) are persistent, and 3) are not due to preventable or correctable reasons, and 4) constitute clinically significant distress or dysfunction to the LTCF resident or represent a danger to the resident or others. There are exceptions that may warrant the use of an anxiolytic such as a long-acting benzodiazepine for withdrawal from a short-acting benzodiazepine, use for neuromuscular syndromes (e.g., tardive dyskinesia, restless legs syndrome, seizure disorder, cerebral palsy), or end of life care. The need for indefinite continuation of clonazepam (e.g., seizure disorder) should be based on confirmation of the condition being treated and its potential cause(s). Benzodiazepines may increase the risk of confusion, sedation, and falls. OBRA provides dosing guidance for clonazepam as an anxiolytic. When a medication is used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.
There are no adequate and well-controlled studies of clonazepam in pregnant women. Available human data on the risk of teratogenicity are inconclusive. There is insufficient evidence in humans to assess the effect of benzodiazepine exposure during pregnancy on neurodevelopment. Perinatal complications have been reported in neonates born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena. Symptoms of perinatal problems in the exposed neonate may include hypothermia, hypotonia, respiratory depression, and difficulty feeding. Animal data indicate teratogenic effects of clonazepam. Pregnant rabbits were given clonazepam doses lower or similar to maximum human doses during the period of organogenesis. Cleft palate, open eyelid, fused sternebrae, and limb defects were observed in a low, non-dose related incidence in exposed litters from all dosage groups. No maternal or embryo-fetal anomalies were noted in mice and rats receiving 4 and 20 times the maximum recommended human dose. Clonazepam has not been studied for use during labor or obstetric delivery. Physicians are advised to recommend that pregnant patients receiving clonazepam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry to provide information about the effects of in utero exposure to the drug. This can be done by calling the registry at 1-888-233-2334, and must be done by patients themselves. Information on this registry can also be found at the website www.aedpregnancyregistry.org.
Avoid prolonged use of clonazepam during breast-feeding, and consider alternative shorter-acting drugs, such as lorazepam. Clonazepam is excreted in breast milk in low concentrations with a milk to plasma ratio of approximately 0.3. However, drug accumulation may occur in the infant due to a long half-life. Sedative effects in the infant, with resultant poor feeding, have been occasionally reported with maternal use of clonazepam. Observational studies suggest that benzodiazepine use, including the use of clonazepam, does not prohibit the initiation of breast-feeding, and that continued maternal use may ensue with close monitoring of the breast-fed infant for sedation, poor feeding, problems with weight gain, and apnea; however, more study is needed. Previous American Academy of Pediatrics (AAP) recommendations considered benzodiazepines to be drugs whose effect on the nursing infant is not known but may be of concern, particularly with prolonged exposure. Consider the developmental and health benefits of breast-feeding along with the mother’s clinical need for clonazepam and any potential adverse effects on the breast-fed infant from clonazepam or the underlying maternal condition.
Long-term administration of clonazepam to adolescents, children, and infants with seizure activity should be carefully considered via a benefit-risk evaluation, given the possibility that adverse effects on physical or mental development could become apparent only after many years. Safety and effectiveness of clonazepam have not been established for treating panic disorder in patients pediatric patients under the age of 18 years.
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