Prescription Drug Information: Clonazepam (Page 4 of 5)

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class:

Clonazepam is a Schedule IV controlled substance.

Physical and Psychological Dependence:

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (e.g., convulsions, psychosis, hallucinations, behavioral disorder, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuance of clonazepam. 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.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed (see DOSAGE AND ADMINISTRATION). 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of patients with panic disorder in Studies 1 and 2 (see CLINICAL PHARMACOLOGY:Clinical Trials), patients were gradually withdrawn during a 7-week downward-titration (discontinuance) period.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.

OVERDOSAGE

Human Experience:

Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma and diminished reflexes.

Overdose Management:

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. The complete flumazenil package insert, including CONTRAINDICATIONS , WARNINGS and PRECAUTIONS , should be consulted prior to use.

Flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines. Antagonism of the benzodiazepine effect in such patients may provoke seizures.

Serious sequelae are rare unless other drugs or alcohol have been taken concomitantly.

DOSAGE AND ADMINISTRATION

Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.

Seizure Disorders:

Adults:

The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam to an existing anticonvulsant regimen.

Pediatric Patients:

Clonazepam is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.

Geriatric Patients:

There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS:Geriatric Use).

Panic Disorder:

Adults:

The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.

Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.

There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Pediatric Patients:

There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age.

Geriatric Patients:

There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS:Geriatric Use).

HOW SUPPLIED

Clonazepam Tablets, USP are available as:

0.5 mg: light yellow, flat-faced beveled edge tablets, scored, debossed “2530″ on one side and debossed “V” on the reverse side, available as follows:

  • Bottles of 100: NDC 43547-406-10
  • Bottles of 500: NDC 43547-406-50
  • Bottles of 1000: NDC 43547-406-11

1 mg: light blue, flat-faced beveled edge tablets, unscored, debossed “2531″ on one side and debossed “V” on the reverse side, available as follows:

  • Bottles of 100: NDC 43547-407-10
  • Bottles of 500: NDC 43547-407-50
  • Bottles of 1000: NDC 43547-407-11

2 mg: white, flat-faced beveled edge tablets, unscored, debossed “2532″ on one side and debossed “V” on the reverse side, available as follows:

  • Bottles of 100: NDC 43547-408-10
  • Bottles of 500: NDC 43547-408-50

Dispense in a tight, light-resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

MEDICATION GUIDE

Read this Medication Guide before you start taking clonazepam tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Clonazepam tablets can cause serious side effects. Because stopping clonazepam tablets suddenly can also cause serious problems, do not stop taking clonazepam tablets without talking to your healthcare provider first.

What is the most important information I should know about clonazepam tablets?

Do not stop taking clonazepam tablets without first talking to your healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems.

Clonazepam tablets can cause serious side effects, including:

1. Clonazepam tablets can slow your thinking and motor skills

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse.

2. Like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempt to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not stop clonazepam tablets without first talking to a healthcare provider.

Stopping clonazepam tablets suddenly can cause serious problems. Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus).

3. Clonazepam tablets may harm your unborn or developing baby.

  • If you take clonazepam tablets during pregnancy, your baby is at risk for serious birth defects. These defects can happen as early as in the first month of pregnancy, even before you know you are pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
  • Children born to mothers receiving benzodiazepine medications (including clonazepam tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.
  • Tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. You and your healthcare provider should decide if you will take clonazepam tablets while you are pregnant.
  • If you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
  • Clonazepam can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clonazepam tablets. You and your healthcare provider should decide if you will take clonazepam tablets or breast feed. You should not do both.

4. Clonazepam tablets can cause abuse and dependence.

  • Do not stop taking clonazepam tablets all of a sudden. Stopping clonazepam tablets suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
    • Talk to your doctor about slowly stopping clonazepam tablets to avoid getting sick with withdrawal symptoms.
    • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Clonazepam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep clonazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

What are clonazepam tablets?

Clonazepam tablets are a prescription medicine used alone or with other medicines to treat:

  • certain types of seizure disorders (epilepsy) in adults and children
  • panic disorder with or without fear of open spaces (agoraphobia) in adults

It is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old.

Who should not take clonazepam tablets?

Do not take clonazepam tablets if you:

  • are allergic to benzodiazepines
  • have significant liver disease
  • have an eye disease called acute narrow angle glaucoma

Ask your healthcare provider if you are not sure if you have any of the problems listed above.

What should I tell my healthcare provider before taking clonazepam tablets?

Before you take clonazepam tablets, tell your healthcare provider if you:

  • have liver or kidney problems
  • have lung problems (respiratory disease)
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking clonazepam tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take clonazepam tablets?

  • Take clonazepam tablets exactly as your healthcare provider tells you. Clonazepam is available as a tablet.
  • Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems.
  • Clonazepam tablets should be taken with water and swallowed whole.
  • If you take too much clonazepam tablets, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking clonazepam tablets?

  • Clonazepam tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse.

What are the possible side effects of clonazepam tablets?

See “What is the most important information I should know about clonazepam tablets?”

Clonazepam tablets can also make your seizures happen more often or make them worse. Call your healthcare provider right away if your seizures get worse while taking clonazepam tablets.

The most common side effects of clonazepam tablets include:

  • Drowsiness
  • Problems with walking and coordination
  • Dizziness
  • Depression
  • Fatigue
  • Problems with memory

These are not all the possible side effects of clonazepam tablets. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088.

How should I store clonazepam tablets?

  • Store clonazepam tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep clonazepam tablets and all medicines out of the reach of children.

General information about clonazepam tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam tablets for a condition for which it was not prescribed. Do not give clonazepam tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about clonazepam tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals.

What are the ingredients in clonazepam tablets?

Active ingredient: clonazepam

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Prinston Laboratories
3241 Woodpark Blvd, Charlotte, NC 28206

Manufactured for:
Solco Healthcare US, LLC Cranbury, NJ 08512, USA

Revised: 06/2017

9040313-01

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