All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with Klonopin, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency. Body as a Whole: Central and Peripheral Nervous System Disorders: Hearing and Vestibular Disorders: Metabolic and Nutritional Disorders: Skin and Appendages Disorders: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.
When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid -related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation. Clonazepam does not appear to alter the pharmacokinetics of carbamazepine or phenobarbital.
Clonazepam has the potential to influence concentrations of phenytoin. Monitoring of phenytoin concentration is recommended when clonazepam is co-administrated with phenytoin. The effect of clonazepam on the metabolism of other drugs has not been investigated. Literature reports suggest that ranitidine , an agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics.
Although clinical studies have not been performed, based on the involvement of the cytochrome P 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents e. The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors and the tricyclic antidepressants , and by other anticonvulsant drugs.
Withdrawal symptoms , similar in character to those noted with barbiturates and alcohol e. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms e. Addiction- prone individuals such as drug addicts or alcoholics should be under careful surveillance when receiving clonazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Following the short-term treatment of patients with panic disorder in Studies 1 and 2 see Clinical Trials , patients were gradually withdrawn during a 7-week downward-titration discontinuance period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.
Concomitant use of benzodiazepines , including Klonopin, and opioids may result in profound sedation, respiratory depression , coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe Klonopin concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Since Klonopin 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. Antiepileptic drugs AEDs , including Klonopin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Pooled analyses of placebo-controlled clinical trials mono- and adjunctive therapy of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk adjusted Relative Risk 1. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27, AED-treated patients was 0. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age 5— years in the clinical trials analyzed. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing Klonopin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and with an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines see Drug Abuse And Dependence.
When used in patients in whom several different types of seizure disorders coexist, Klonopin 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 Klonopin may produce absence status.
In some cases, dosage adjustment may reestablish efficacy. Periodic blood counts and liver function tests are advisable during long-term therapy with Klonopin. Physical And Psychological Dependence. Paradoxical reactions are more likely to occur in children and in the elderly. The abrupt withdrawal of Klonopin, particularly in those patients on long-term, high-dose therapy, may precipitate status epilepticus.
Therefore, when discontinuing Klonopin, gradual withdrawal is essential. While Klonopin is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated. Metabolites of Klonopin 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. Klonopin may produce an increase in salivation.
This should be considered before giving the drug to patients who have difficulty handling secretions. Klonopin may cause respiratory depression and should be used with caution in patients with compromised respiratory function e. Klonopin may have a porphyrogenic effect and should be used with care in patients with porphyria. A Klonopin Medication Guide must be given to the patient each time Klonopin is dispensed, as required by law.
Patients should be instructed to take Klonopin only as prescribed. Physicians are advised to discuss the following issues with patients for whom they prescribe Klonopin:. Inform patients and caregivers that potentially fatal additive effects may occur if Klonopin is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider see WARNINGS: 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.
Because benzodiazepines have the potential to impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Klonopin therapy does not affect them adversely. Patients, their caregivers, and families should be counseled that AEDs, including Klonopin, may increase the risk of suicidal thoughts and behavior and should be advised 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.
This registry is collecting information about the safety of antiepileptic drugs during pregnancy. Patients should be advised to notify their physician if they are breastfeeding or intend to breastfeed during therapy. 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.
Carcinogenicity studies have not been conducted with clonazepam. The data currently available are not sufficient to determine the genotoxic potential of clonazepam. There are no adequate and well-controlled studies of Klonopin 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.
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 the later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period. In three studies in which clonazepam was administered orally to pregnant rabbits at doses of 0. Data for other benzodiazepines suggest the possibility of adverse developmental effects long-term effects on neurobehavioral and immunological function in animals following prenatal exposure to benzodiazepines.
To provide information regarding the effects of in utero exposure to Klonopin, physicians are advised to recommend that pregnant patients taking Klonopin enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number , and must be done by patients themselves. Information on this registry can also be found at the website http: The effects of Klonopin on the breastfed infant and on milk production are unknown.
Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established. Clinical studies of Klonopin 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. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Klonopin and observed closely.
Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence , confusion, coma, and diminished reflexes. Treatment includes monitoring of respiration , pulse and blood pressure, general supportive measures and immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol.
Dialysis is of no known value. Flumazenil, a specific benzodiazepine-receptor antagonist , is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose.
Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines.
Clonazepam passes into breast milk and causes side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication. The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. This dosage information is for clonazepam oral tablet.
All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:. Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages.
Always speak with your doctor or pharmacist about dosages that are right for you. Clonazepam oral tablet is used for short-term treatment. If you stop taking it suddenly, you may have symptoms of withdrawal. These include irritability, trouble sleeping, and anxiety. If you take too much: You could have dangerous levels of the drug in your body.
Symptoms of an overdose of this drug can include:. If your symptoms are severe, call or go to the nearest emergency room right away. What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects. How to tell if the drug is working: You should have fewer panic attacks or seizures.
A prescription for this medication is refillable. However, clonazepam is a schedule IV controlled substance. Therefore, your prescription for this drug may be refilled no more than five times. Also, you can only get refills for six months after the date your doctor wrote the original prescription. You and your doctor should monitor certain health issues. This can help make sure you stay safe while you take this drug. Many insurance companies require a prior authorization for this drug.
This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription. There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you. Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date.
However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
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