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Klonopin

Generic Name: Clonazepam
Drug Category: Benzodiazepine
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 0 week old and under the age of 65 years old for a maximum duration of 12 weeks.

Approved Uses

Indicated for:

Seizure Disorders: (Infants, Children, Adults)

• Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful.

Panic Disorder: (Adults)

• Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

Antiepileptic drugs (AEDs), including Klonopin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Paradoxical reactions, such as agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations, and psychoses are known to occur when using benzodiazepines.

The effectiveness of Klonopin in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials.

Klonopin is contraindicated in patients with the following conditions:

  • Clinical or biochemical evidence of significant liver disease
  • Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy)

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

The continued use of benzodiazepines, including Klonopin, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Klonopin after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Klonopin or reduce the dosage.

In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.

Klonopin may cause respiratory depression and should be used with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, sleep apnea).

Klonopin may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions.

Klonopin may have a porphyrogenic effect and should be used with care in patients with porphyria.

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.

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.

Patients should be advised to avoid alcohol while taking Klonopin.

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 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.

The concomitant use of valproic acid and Klonopin may produce absence status.

Although clinical studies have not been performed, based on the involvement of the cytochrome P450 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents (e.g., fluconazole), should be used cautiously in patients receiving clonazepam because they may impair the metabolism of clonazepam leading to exaggerated concentrations and effects.

Clonazepam has the potential to influence concentrations of phenytoin. Monitoring of phenytoin concentration is recommended when clonazepam is co-administered with phenytoin.

An increased risk of congenital malformations associated with the use of benzodiazepine drugs has been suggested in several studies. 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.

Mothers receiving Klonopin should not breastfeed their infants.

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Off-label Uses

• Use in patients under the age of 18 for panic disorder. GoToSource

• Acute alcohol withdrawal. GoToSource

• Insomnia and restless legs syndrome. GoToSource

• Social phobia. GoToSource

• Post traumatic stress disorder. GoToSource

• Tardive tourette syndrome. GoToSource

• Stiff-man syndrome. GoToSource

• Supplementary treatment for depression. GoToSource

• Bipolar disorder. GoToSource

• Catatonia. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Schizophrenia. GoToSource

• Tinnitus and vestibular disorder. GoToSource

• Prevention of high dose busulfan-induced seizures in adult patients. GoToSource

• Epilepsy with angelman and dravet syndrome. GoToSource

• Essential palatal tremor. GoToSource

• Burning mouth syndrome. GoToSource

• Myofascial pain syndrome. GoToSource

• Migraine. GoToSource

• Alien limb syndrome. GoToSource 

• Chronic neuropathic pain or fibromyalgia. GoToSource 

• Prevention of acute and delayed vomiting induced by cisplatin-based chemotherapy for lung cancer. GoToSource 

• Dystonia. GoToSource 

• Neuroleptic-induced akathisia. GoToSource 

• Nystagmus. GoToSource 

• Tic douloureux. GoToSource

Adverse Events

Emergence or worsening of depression. GoToSource

Pancytopenia (decreased red blood cells, white blood cells and platelets) or thrombocytopenia (low blood platelet count). GoToSource

Increased risk of suicide. GoToSource

Birth defects. GoToSource

Cardiomyopathy. GoToSource

Maculopapular rash. GoToSource

Withdrawal symptoms, cognitive impairment and sedation. GoToSource

Increased risk of brain, colorectal and lung cancer with long-term use. GoToSource 

Nontraumatic fractures in patients 50 years and older. GoToSource 

Atrioventricular block (type of heart block). GoToSource 

Withdrawal-induced catatonia. GoToSource 

Toxic retinopathy with long-term use. GoToSource 

Fatal drug interaction when used with oxycodone (oxycontin). GoToSource 

Decreased bone mineral density. GoToSource 

Liver damage. GoToSource 

Disinhibition and sexual dysfunction. GoToSource 

Abuse, dependence, paradoxical reactions (including agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations and psychoses) and respiratory depression. GoToSource

Ataxia (abnormal, uncoordinated movements). GoToSource

Litigation

Lawsuits filed for dependency, withdrawal and suicidal thoughts or behavior. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024