Clonazepam precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of precautions
General
Cognitive and motor performance
Worsening of seizures
Laboratory testing
Risks of abrupt withdrawal
Renally imparired patients
Hypersalivation
Information for patients
Carcinogenesis, mutagenesis, impairment of fertility
Pregnancy
Labor & delivery
Nursing mothers
Pediatric use
Geriatric use
General
Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs. An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies. Return to top
Cognitive and motor performance
ince Clonazepam produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle. They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during Clonazepam therapy . Return to top
Worsening of seizures
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 (grand mal). This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status. Return to top
Laboratory testing
Periodic blood counts and liver function tests are advisable during long-term therapy with Clonazepam. Return to top
Risks of abrupt withdrawal
The abrupt withdrawal of Clonazepam, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus. Therefore, when discontinuing Clonazepam, gradual withdrawal is essential. While Clonazepam is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated. Return to top
Renally imparired patients
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 impaired renal function. Return to top
Hypersalivation
Clonazepam may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions. Because of this and the possibility of respiratory depression, Clonazepam should be used with caution in patients with chronic respiratory diseases. Return to top
Information for patients
Physicians are advised to discuss the following issues with patients for whom they prescribe Clonazepam:
- Dose changes: To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.
- Interference with cognitive and motor performance: Because benzodiazepines have the potential to impair judgement, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Clonazepam therapy does not affect them adversely.
- Pregnancy:Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Clonazepam.
- Nursing:Patients should be advised not to breastfeed an infant if they are taking Clonazepam.
- Concomitant medication’’: Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.
- Alcohol: Patients should be advised to avoid alcohol while taking Clonazepam.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity studies have not been conducted with Clonazepam.
The data currently available are not sufficient to determine the genotoxic potential of Clonazepam. Return to top
Pregnancy
Teratogenic Effects
- Pregnancy Category D
Data from several sources raise concerns about the use of Clonazepam during pregnancy. There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.
In general, the use of Clonazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus.
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Labor & delivery
The effect of Clonazepam on labor and delivery in humans has not been specifically studied however, perinatal complications have been reported in children born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena. Return to top
Nursing mothers
Mothers receiving Clonazepam should not breastfeed their infants. Return to top
Pediatric use
Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of Clonazepam is important in pediatric patients being treated for seizure disorder (
Safety and effectivess in pediatric patients with panic disorder below the age of 18 have not been established. Return to top
Geriatric use
Clinical studies of Clonazepam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Because Clonazepam undergoes hepatic metabolism, it is possible that liver disease will impair Clonazepam elimination. Metabolites of Clonazepam are excreted by kidneys; to avoid their excess accumulation, caution should be excercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal functions at the time of dose selection.
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patient generally should be started on low doses of Clonazepam and observed closely.Return to top
Adapted from the FDA Package Insert.