Klonopin

Clonazepam is used alone or in combination with other medications to control certain types of seizures. It is also used to relieve panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Clonazepam is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.

Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mg—FD&C Yellow No. 6 Lake; 1 mg—FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake.

Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

Pregnancy category: D

Lactation: Excreted in breast milk; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Klonopin for adults with seizure disorders should not exceed 1.5 mg/day divided into 3 doses. Maximum recommended daily dose is 20 mg.

In order to minimize drowsiness, the starting 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 2 or 3 divided doses. Whenever possible, the daily dose should be divided into 3 equal doses. If doses are not equally divided, the largest dose should be given before going to bed.

Contraindications

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.

• Known hypersensitivity to clonazepam or other benzodiazepines.1

• Clinical or biochemical evidence of substantial hepatic impairment.1

• Manufacturer states that clonazepam is contraindicated in patients with acute angle-closure glaucoma but may be administered to patients with open-angle glaucoma who are receiving appropriate therapy;1 however, clinical rationale for this contraindication has been questioned.c

Warnings/Precautions

Warnings

Performance of activities requiring mental alertness and physical coordination may be impaired.1

Concurrent use of other CNS depressants may potentiate CNS depression.1 (See Specific Drugs under Interactions.)

Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates or alcohol).1 8 Symptoms may be relieved by tapering the dosage.1

General Precautions

May increase the incidence or precipitate the onset of generalized tonic-clonic seizures in patients with multiple types of seizure disorders.1 Consider addition of appropriate anticonvulsants or an increase in their dosages.1

Abrupt withdrawal, particularly in patients receiving long-term, high-dose therapy, may result in status epilepticus.1

Concomitant use with valproic acid may produce absence status.1

Perform blood counts and liver function tests periodically during long-term therapy.1

May increase salivation; use with caution in patients who have difficulty tolerating or clearing secretions.1

Possible hypersalivation and respiratory depression in patients with chronic respiratory disease; use with caution in such patients.1 b

Psychologic and physical dependence may occur following prolonged use.1

Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.1

Use with caution in depressed patients; potential for suicidal tendencies.c Prescribe drug in the smallest feasible quantity.c

Do not use in patients with depressive neuroses or psychotic reactions in which anxiety is not prominent.c

Specific Populations

Category D.1

Distributed into milk;c discontinue nursing or the drug.1

Effects of long-term administration on physical and mental development have not been established.1 b Administer to children with seizure disorders only if potential benefits outweigh possible risks.1 b

Safety and efficacy for treatment of panic disorder not established in children <18 years of age;1 however, clonazepam has been effective in a limited number of adolescents with panic disorder.22

Insufficient experience from clinical studies to determine whether patients ≥65 years of age respond differently than younger adults.a Other clinical experience has not identified age-related differences in responses. Potential increased sensitivity (increased risk of oversedation and confusion) to sedatives.a

Select dosage carefully, generally initiating therapy at low dosage; observe closely.a Consider the increased incidence of hepatic and renal impairment, decreased cardiac function, and concomitant disease and drug therapy in the geriatric population.a May be useful to assess hepatic and/or renal function when selecting dosage.a

Prolonged elimination.1 c Contraindicated in patients with clinical or biochemical evidence of substantial liver disease.1

Elimination of metabolites may be decreased; use with caution.1

Common Adverse Effects

Sedation/drowsiness, ataxia/hypotonia, behavioral disturbances (principally in children) including aggressiveness, irritability, agitation, hyperkinesis.b

Storage

Oral

25°C (may be exposed to 15–30°C).a

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.

• Importance of taking only as prescribed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician.1

• Importance of not abruptly discontinuing therapy; consult clinician about discontinuing use.1

• Potential for psychologic or physiologic dependence.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, particularly depression.1

• Importance of avoiding alcohol-containing beverages or products.1

• Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.1

• Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.c

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IV) drug.1

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clonazepam is used alone or together with other medicines to treat certain seizure disorders (eg, Lennox-Gastaut syndrome, akinetic, myoclonic, and absence seizures). It is also used to treat panic disorder. Clonazepam is a benzodiazepine that works in the brain to prevent seizures. Benzodiazepines are central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• cough
• difficulty breathing
• discouragement
• dizziness
• ear congestion
• feeling sad or empty
• fever
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of voice
• nasal congestion
• poor coordination
• runny nose
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• tiredness
• trouble concentrating
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

• Being forgetful
• bladder pain
• bloody or cloudy urine
• change in speech
• diarrhea
• difficult, burning, or painful urination
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle aches and pains
• nausea
• nervousness
• problems in urination or increase in the amount of urine
• shivering
• slurred speech
• sore throat
• sweating
• trouble speaking
• vomiting

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color
• chest pain or discomfort
• cold sweats
• colds
• confusion
• cough or hoarseness
• difficulty with sleeping
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• excessive dreaming
• excessive muscle tone
• excitement
• falling
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling mad
• feeling of unreality
• flu-like symptoms
• headache, severe and throbbing
• lack of feeling or emotion
• lack or loss of self-control
• muscle stiffness
• muscle tension or tightness
• nightmares
• pain, inflammation, or swelling in the calves, shoulders, or hands
• pain or swelling in the arms or legs without any injury
• pain, tenderness, or swelling of the foot or leg
• partial or slight paralysis
• scaling
• sense of detachment from self or body
• shakiness in the legs, arms, hands, or feet
• skin rash
• swelling around the eyes
• swelling of the face, ankle, foot, or knees
• thoughts of killing oneself changes in behavior
• tightness in the chest
• trembling or shaking of the hands or feet
• uncaring
• vision changes

• Abdominal pain or fullness
• anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• change in consciousness
• chest congestion
• difficulty with coordination
• double vision
• drowsiness
• dry mouth
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• hyperventilation
• irregular, fast, slow, or shallow breathing
• irregular, twisting uncontrolled movement of the face, hands, arms, or legs
• loss of interest or pleasure
• loss of memory
• loss of strength or energy
• loss of voice
• muscle weakness
• pale or blue lips, fingernails, or skin
• pinpoint red spots on the skin
• problems with memory
• restlessness
• severe mood or mental changes
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• troubled breathing with exertion
• uncontrolled eye movements
• unusual behavior
• unusual bleeding or bruising
• unusual weakness
• vivid dreams
• weight loss or gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• difficulty with swallowing
• dryness or soreness of the throat
• heavy bleeding
• hives
• inability to have or keep an erection
• longer than usual time to ejaculation of semen
• loss in sexual ability, desire, drive, or performance
• pain or tenderness around the eyes and cheekbones
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• voice changes

• Acid or sour stomach
• ankle, knee, or great toe joint pain
• belching
• bleeding after defecation
• blistering, burning, crusting, dryness, or flaking of the skin
• bloated
• blurred or loss of vision
• change in color perception
• cracks in the skin at the corners of the mouth
• decrease or change in vision
• difficulty moving
• double vision
• dryness of the eyes
• earache
• excess air or gas in stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth
• frequent bowel movements
• full feeling
• hair loss or thinning of the hair
• halos around lights
• heartburn
• increased watering of the mouth
• indigestion
• irregularities in menstruation
• itching in the genital or other skin areas
• itching, scaling, severe redness, soreness, or swelling of the skin
• joint stiffness or swelling
• leg or muscle cramps
• loss of taste
• night blindness
• nosebleeds
• overbright appearance of lights
• pain in the breasts or pelvic area
• pain in the leg, nape, or back
• passing gas
• red, sore eyes
• redness of the face, neck, arms, and occasionally, upper chest
• redness or swelling in the ear
• sensation of spinning
• smaller amount of semen ejaculated than usual
• sore on the edge of the eyelid
• soreness or redness around the fingernails and toenails
• stomach discomfort, upset, or pain
• thickening of the tongue
• thirst
• tooth disorder
• toothache
• tunnel vision
• twitching of the eyes
• uncomfortable swelling around the anus
• worsening of acne

• Burning feeling in the chest or stomach
• difficulty having a bowel movement (stool)
• increased appetite
• increased hair growth, especially on the face
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• sore gums
• tenderness in the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat seizures.
• It is used to treat panic attacks.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Hard stools (constipation).
• Drooling.
• Dizziness.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam. Each tablet also contains lactose, magnesium stearate, microcrystalline cellulose and corn starch, with the following colorants: 0.5 mgFD&C Yellow No. 6 Lake; 1 mgFD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake.

Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

Pharmacodynamics

The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. Convulsions produced in rodents by pentylenetetrazol or, to a lesser extent, electrical stimulation are antagonized, as are convulsions produced by photic stimulation in susceptible baboons. A taming effect in aggressive primates, muscle weakness and hypnosis are also produced. In humans, clonazepam is capable of suppressing the spike and wave discharge in absence seizures (petit mal) and decreasing the frequency, amplitude, duration and spread of discharge in minor motor seizures.

Pharmacokinetics

Clonazepam is rapidly and completely absorbed after oral administration. The absolute bioavailability of clonazepam is about 90%. Maximum plasma concentrations of clonazepam are reached within 1 to 4 hours after oral administration. Clonazepam is approximately 85% bound to plasma proteins. Clonazepam is highly metabolized, with less than 2% unchanged clonazepam being excreted in the urine. Biotransformation occurs mainly by reduction of the 7-nitro group to the 4-amino derivative. This derivative can be acetylated, hydroxylated and glucuronidated. Cytochrome P-450 including CYP3A, may play an important role in clonazepam reduction and oxidation. The elimination half-life of clonazepam is typically 30 to 40 hours. Clonazepam pharmacokinetics are dose-independent throughout the dosing range. There is no evidence that clonazepam induces its own metabolism or that of other drugs in humans.

Controlled studies examining the influence of gender and age on clonazepam pharmacokinetics have not been conducted, nor have the effects of renal or liver disease on clonazepam pharmacokinetics been studied. Because clonazepam undergoes hepatic metabolism, it is possible that liver disease will impair clonazepam elimination. Thus, caution should be exercised when administering clonazepam to these patients.

Clinical Trials

The effectiveness of Klonopin in the treatment of panic disorder was demonstrated in two double-blind, placebo-controlled studies of adult outpatients who had a primary diagnosis of panic disorder (DSM-IIIR) with or without agoraphobia. In these studies, Klonopin was shown to be significantly more effective than placebo in treating panic disorder on change from baseline in panic attack frequency, the Clinician's Global Impression Severity of Illness Score and the Clinician's Global Impression Improvement Score.

Study 1 was a 9-week, fixed-dose study involving Klonopin doses of 0.5, 1, 2, 3 or 4 mg/day or placebo. This study was conducted in four phases: a 1-week placebo lead-in, a 3-week upward titration, a 6-week fixed dose and a 7-week discontinuance phase. A significant difference from placebo was observed consistently only for the 1 mg/day group. The difference between the 1 mg dose group and placebo in reduction from baseline in the number of full panic attacks was approximately 1 panic attack per week. At endpoint, 74% of patients receiving clonazepam 1 mg/day were free of full panic attacks, compared to 56% of placebo-treated patients.

Study 2 was a 6-week, flexible-dose study involving Klonopin in a dose range of 0.5 to 4 mg/day or placebo. This study was conducted in three phases: a 1-week placebo lead-in, a 6-week optimal-dose and a 6-week discontinuance phase. The mean clonazepam dose during the optimal dosing period was 2.3 mg/day. The difference between Klonopin and placebo in reduction from baseline in the number of full panic attacks was approximately 1 panic attack per week. At endpoint, 62% of patients receiving clonazepam were free of full panic attacks, compared to 37% of placebo-treated patients.

Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of race or gender.

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 (eg, 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 (eg, 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.

Klonopin® (KLON-oh-pin)
(clonazepam)
Tablets

CIV

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 side effects.
• Klonopin is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.
• Klonopin can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Klonopin affects you.
  • Klonopin may cause problems with your coordination, especially when you are walking or picking things up.
• 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.
• Like other antiepileptic drugs, Klonopin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

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

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).
• 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.
• 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 healthcare provider about slowly stopping Klonopin to avoid 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 federal 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 healthcare provider 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.

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.

Before you take Klonopin,tell your healthcare provider about all your medical conditions, including if you:

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Klonopin with certain other medicines can cause side effects or affect how well Klonopin or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

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 medicines that may make you sleepy or dizzy while taking Klonopin until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, Klonopin may make your sleepiness or dizziness much 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:

These are not all the possible side effects of Klonopin. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

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 the safe and effective use of 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.

You can ask your pharmacist or healthcare provider for information about Klonopin that is written for health professionals.

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

Revised: December 2016

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

Distributed by:

Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

© 2016 Genentech, Inc. All rights reserved.

For more information, go to www.gene.com/patients/medicines//Klonopin. or call 1-877-436-3683

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

Get emergency medical help if you have signs of an allergic reaction to Klonopin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• new or worsening seizures;

• severe drowsiness;

• unusual changes in mood or behavior;

• confusion, aggression, hallucinations;

• thoughts of suicide or hurting yourself;

• weak or shallow breathing;

• pounding heartbeats or fluttering in your chest; or

• unusual or involuntary eye movements.

Common Klonopin side effects may include:

• feeling tired or depressed;

• drowsiness, dizziness;

• memory problems; or

• problems with balance or coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Clonazepam is quickly absorbed and peak concentrations are reached within 1 to 4 hours. One dose can last up to 24 hours; however, split dosages throughout the day may be preferred.

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