Klonopin

Name: Klonopin

What special precautions should I follow?

Before taking clonazepam,

  • tell your doctor and pharmacist if you are allergic to clonazepam, other benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium, in Librax), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), midazolam (Versed), oxazepam, temazepam (Restoril), triazolam (Halcion), any other medications, or any of the ingredients in clonazepam tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (Erythrocin, E-mycin, others), and troleandomycin (TAO) (not available in the US); antidepressants; certain antifungal medications such as itraconazole (Onmel. Sporanox) and ketoconazole (Nizoral); antihistamines; certain calcium channel blockers such as diltiazem (Cardizem, Tiazac, others) and verapamil (Calan, Covera, Verelan, in Tarka); cimetidine (Tagamet); HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); medications for anxiety, colds or allergies, or mental illness; other medications for seizures such as carbamazepine (Epitol, Tegretol, Teril), phenobarbital, phenytoin (Dilantin, Phenytek), or valproic acid (Depakene); muscle relaxants; nefazodone; rifampin (Rifadin, Rimactane); sedatives; certain selective serotonin reuptake inhibitors (SSRIs) such as fluvoxamine (Luvox); other sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you have or have ever had glaucoma (increased pressure in the eye that may cause vision loss) or liver disease. Your doctor may tell you not to take clonazepam.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have or have ever had lung or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Clonazepam may harm the fetus. If you become pregnant while taking clonazepam, call your doctor.
  • talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should receive low doses of clonazepam because higher doses may not work better and may cause serious side effects.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clonazepam.
  • you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • you should know that your mental health may change in unexpected ways, and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking clonazepam for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as clonazepam to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as clonazepam, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood), talking or thinking about wanting to hurt yourself or end your life, withdrawing from friends and family; preoccupation with death and dying, giving away prized possessions, or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What brand names are available for clonazepam?

Klonopin

Is clonazepam safe to take if I'm pregnant or breastfeeding?

  • Clonazepam and other benzodiazepines have been associated with fetal damage, including congenital malformations, when taken by pregnant women in their first trimester. Clonazepam is best avoided in the first trimester and probably throughout pregnancy.
  • Benzodiazepines are secreted in breast milk. Mothers who are breastfeeding should not take clonazepam.

Indications

Seizure Disorders

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.

In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.

Panic Disorder

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.

The efficacy of Klonopin was established in two 6-to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).

Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

The effectiveness of Klonopin in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Patient information

KLONOPIN®
(KLON-oh-pin)
(clonazepam) Tablets and Wafers

Read this Medication Guide before you start taking KLONOPIN 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.

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

What is the most important information I should know about KLONOPIN?

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

KLONOPIN can cause serious side effects, including:

1. KLONOPIN can slow your thinking and motor skills

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

2. Like other antiepileptic drugs, KLONOPIN 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 KLONOPIN without first talking to a healthcare provider.

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

3. KLONOPIN may harm your unborn or developing baby.

  • If you take KLONOPIN 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 KLONOPIN) 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 KLONOPIN. You and your healthcare provider should decide if you will take KLONOPIN while you are pregnant.
  • If you become pregnant while taking KLONOPIN, 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.
  • KLONOPIN can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take KLONOPIN. You and your healthcare provider should decide if you will take KLONOPIN or breast feed. You should not do both.

4. KLONOPIN can cause abuse and dependence.

  • Do not stop taking KLONOPIN all of a sudden. Stopping KLONOPIN 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 KLONOPIN 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.

KLONOPIN is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep KLONOPIN in a safe place to prevent misuse and abuse. Selling or giving away KLONOPIN 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 is KLONOPIN?

KLONOPIN is 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 KLONOPIN is safe or effective in treating panic disorder in children younger than 18 years old.

Who should not take KLONOPIN?

Do not take KLONOPIN 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 KLONOPIN?

Before you take KLONOPIN, 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 KLONOPIN 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 KLONOPIN?

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

What should I avoid while taking KLONOPIN?

KLONOPIN can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how KLONOPIN affects you.

Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking KLONOPIN until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, KLONOPIN may make your sleepiness or dizziness worse.

What are the possible side effects of KLONOPIN?

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

KLONOPIN 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 KLONOPIN.

The most common side effects of KLONOPIN include:

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

These are not all the possible side effects of KLONOPIN. 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 FDA at 1-800-FDA-1088.

How should I store KLONOPIN?

  • Store KLONOPIN between 59°F to 86°F (15°C to 30°C)

Keep KLONOPIN and all medicines out of the reach of children.

General Information about KLONOPIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KLONOPIN for a condition for which it was not prescribed. Do not give KLONOPIN 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 KLONOPIN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about KLONOPIN that is written for health professionals.

For more information, go to www.gene.com/patients/medicines/klonopin.

What are the ingredients in KLONOPIN?

Active ingredient: clonazepam

Inactive ingredients:

  • Tablets:
    • 0.5 mg tablets contain lactose, magnesium stearate, microcrystalline cellulose, corn starch, FD&C Yellow No. 6 Lake
    • 1 mg tablets contain lactose, magnesium stearate, microcrystalline cellulose, corn starch, FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake
    • 2 mg tablets contain lactose, magnesium stearate, microcrystalline cellulose, corn starch

Klonopin Drug Class

Klonopin is part of the drug class:

  • Anxiolytic Benzodiazepine

Klonopin Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Klonopin there are no specific foods that you must exclude from your diet when receiving Klonopin.

Klonopin and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Taking this medication while pregnant may cause harm to the unborn baby. Tell your doctor if you become pregnant or intend to become pregnant during therapy with Klonopin. It is encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if you become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, you can call the toll free number 1-888-233-2334.

Uses for Klonopin

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Seizure Disorders

Prophylactic management of Lennox-Gastaut syndrome and akinetic and myoclonic seizures.1 b d

Management of absence seizures in patients unresponsive to succinimides.1 b d

Some evidence of success in the management of refractory seizures†, including partial seizures with complex symptomatology and other partial seizures and some cases of infantile spasms†.b d

Useful in some patients with tonic-clonic seizures†.b d

Panic Disorder

Treatment of panic disorder with or without agoraphobia.1 3

Catatonia

Also has been used for treatment of acute catatonic reactions†, whether associated with schizophrenia or other conditions.

Akathisia

May be helpful in patients experiencing akathisia† while receiving antipsychotic drugs (e.g., for management of schizophrenia).

Klonopin 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 Klonopin to an existing anticonvulsant regimen.

Pediatric Patients

Klonopin 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 Klonopin in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of Klonopin 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 Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Pediatric Patients

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

Geriatric Patients

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

PRINCIPAL DISPLAY PANEL - 0.5 mg Tablet Bottle Label

NDC 0004-0068-01

Klonopin®
(clonazepam)

0.5 mg

Each tablet contains 0.5 mg clonazepam.

ATTENTION PHARMACIST: Dispense the
accompanying Medication Guide to each patient.
For additional Medication Guides call
1-877-436-3683 or visit
www.gene.com/gene/products/information/Klonopin.

100 tablets
Rx only

Genentech

10176218

How should I take Klonopin?

Take Klonopin exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Klonopin may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Klonopin should be used for only a short time. Do not take this medication for longer than 9 weeks without your doctor's advice.

Swallow the tablet whole, with a full glass of water.

If you use this medicine long-term, you may need frequent medical tests.

Do not stop using Klonopin suddenly or you could have unpleasant withdrawal symptoms, including a seizure (convulsions). Ask your doctor how to safely stop using this medicine.

Call your doctor if this medicine seems to stop working as well in treating your seizures or anxiety symptoms.

Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Klonopin is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

In Summary

Common side effects of Klonopin include: drowsiness. Other side effects include: upper respiratory tract infection, ataxia, depression, and dizziness. See below for a comprehensive list of adverse effects.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Drowsiness, depression, dizziness, ataxia (the loss of full control of body movements), body aches and pains, palpitations, memory disturbance, increased salivation, headache, sinusitis, and tiredness have all been reported.
  • Clonazepam is potentially addictive and may cause emotional or physical dependence.
  • Withdrawal symptoms (including convulsions, tremor, cramps, vomiting, sweating, or insomnia) may occur with abrupt discontinuation; taper off slowly under a doctor's supervision.
  • Drowsiness caused by Klonopin may impair judgment and affect your ability to drive or operate machinery. May also increase the risk of falls. Avoid alcohol.
  • Klonopin, as with similar drugs used in the treatment of epilepsy or depression, can increase the risk of suicidal thoughts or behavior. Monitor mood.
  • Avoid combining Klonopin with opioids such as oxycodone or hydrocodone. Profound sedation, respiratory depression (abnormally slow and shallow breathing), coma, and death may result. May also interact with a number of other drugs including those that induce or inhibit cytochrome 4503A hepatic enzymes.
  • Some studies have shown that up to 30% of people taking Klonopin have shown a loss of anticonvulsant activity within three months of starting Klonopin. An increase in dosage may restore effectiveness.
  • Not suitable for people with significant liver disease or acute narrow-angle glaucoma. Dosage may need to be reduced in people with kidney disease. May not be suitable for those people whose breathing is already compromised or who have porphyria.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

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