CLONAZEPAM- clonazepam_tablet, orally disintegrating

Pharmacodynamics: Pharmacokinetics: Pharmacokinetics in Demographic Subpopulations and in Disease States: Clinical Trials: Panic Disorder Study 1 was a 9-week, fixed-dose study involving clonazepam orally disintegrating tablets 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 clonazepam orally disintegrating tablets 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. The difference between clonazepam orally disintegrating tablets 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.

Seizure Disorders: Panic Disorder: The efficacy of clonazepam orally disintegrating tablets 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 clonazepam orally disintegrating tablets 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 clonazepam orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION

Clonazepam is available as an orally disintegrating tablet. The orally disintegrating tablet should be administered as follows: Immediately upon opening the bottle, using dry hands, remove the tablet and place it in the mouth. Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without water. Seizure Disorders: Adults The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding clonazepam orally disintegrating tablets to an existing anticonvulsant regimen. Pediatric Patients Geriatric Patients PRECAUTIONS: Geriatric Use Panic Disorder: Adults 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 orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Pediatric Patients Geriatric Patients PRECAUTIONS: Geriatric Use Discontinuation or Dosage Reduction of Clonazepam Orally Disintegrating Tablets: To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue clonazepam orally disintegrating tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions DRUG ABUSE AND DEPENDENCE: Dependence.

The adverse experiences for clonazepam orally disintegrating tablets are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders: The most frequently occurring side effects of clonazepam orally disintegrating tablets are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of clonazepam orally disintegrating tablets are: Cardiovascular: Palpitations Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums Genitourinary: Dysuria, enuresis, nocturia, urinary retention Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase Musculoskeletal: Muscle weakness, pains Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia, dysarthria, dysdiadochokinesis, “glassy-eyed” appearance, headache, hemiparesis, hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis, (the behavior effects are more likely to occur in patients with a history of psychiatric disturbances). The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages Panic Disorder: The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials: Adverse Events Associated With Discontinuation of Treatment: Table 2 Most Common Adverse Events (>=1%) Associated with Discontinuation of Treatment Adverse Event Clonazepam orally disintegrating tablets (N=574) Placebo (N=294) Somnolence 7% 1% Depression 4% 1% Dizziness 1% <1% Nervousness 1% 0% Ataxia 1% 0% Intellectual Ability Reduced 1% 0% Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam orally disintegrating tablets -Treated Patients: Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials. Events reported in 1% or more of patients treated with clonazepam orally disintegrating tablets (doses ranging from 0. 5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included. The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied. Treatment-Emergent Adverse Event Incidence in 6- to 9-Week Placebo-Controlled Clinical Trials* * Events reported by at least 1% of patients treated with clonazepam orally disintegrating tablets and for which the incidence was greater than that for placebo. dagger Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was <=0. double dagger Denominators for events in gender-specific systems are: n=240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female. Clonazepam Maximum Daily Dose Adverse Event by Body System <1mg 1 to <2mg 2 to <3mg >= 3mg All Clonazepam orally disintegrating tablets Groups Placebo n=96 n=129 n=113 n=235 N=574 N=294 % % % % % % Central & Peripheral Nervous System Somnolence dagger 26 35 50 36 37 10 Dizziness 5 5 12 8 8 4 Coordination Abnormal dagger 1 2 7 9 6 0 Ataxia dagger 2 1 8 8 5 0 Dysarthria dagger 0 0 4 3 2 0 Psychiatric Depression 7 6 8 8 7 1 Memory Disturbance 2 5 2 5 4 2 Nervousness 1 4 3 4 3 2 Intellectual Ability Reduced 0 2 4 3 2 0 Emotional Lability 0 1 2 2 1 1 Libido Decreased 0 1 3 1 1 0 Confusion 0 2 2 1 1 0 Respiratory System Upper Respiratory Tract Infection dagger 10 10 7 6 8 4 Sinusitis 4 2 8 4 4 3 Rhinitis 3 2 4 2 2 1 Coughing 2 2 4 0 2 0 Pharyngitis 1 1 3 2 2 1 Bronchitis 1 0 2 2 1 1 Gastrointestinal System Constipation dagger 0 1 5 3 2 2 Appetite Decreased 1 1 0 3 1 1 Abdominal Pain dagger 2 2 2 0 1 1 Body as a Whole Fatigue 9 6 7 7 7 4 Allergic Reaction 3 1 4 2 2 1 Musculoskeletal Myalgia 2 1 4 0 1 1 Resistance Mechanism Disorders Influenza 3 2 5 5 4 3 Urinary System Micturition Frequency 1 2 2 1 1 0 Urinary Tract Infection dagger 0 0 2 2 1 0 Vision Disorders Blurred Vision 1 2 3 0 1 1 Reproductive Disorders double dagger Female Dysmenorrhea 0 6 5 2 3 2 Colpitis 4 0 2 1 1 1 Male Ejaculation Delayed 0 0 2 2 1 0 Impotence 3 0 2 1 1 0 Commonly Observed Adverse Events: Table 4. Incidence of Most Commonly Observed Adverse Events* in Acute Therapy in Pool of 6- to 9-Week Trials *Treatment-emergent events for which the incidence in the clonazepam patients was >=5% and at least twice that in the placebo patients. Adverse Event Clonazepam (N=574) Placebo (N=294) Somnolence 37% 10% Depression 7% 1% Coordination Abnormal 6% 0% Ataxia 5% 0% In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term “depression” were reported in 7% of clonazepam orally disintegrating tablets -treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term “depression” were reported as leading to discontinuation in 4% of clonazepam orally disintegrating tablets -treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the clonazepam group than the placebo group suggesting that clonazepam orally disintegrating tablets -treated patients were not experiencing a worsening or emergence of clinical depression. Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with clonazepam orally disintegrating tablets at multiple doses during clinical trials. 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 clonazepam orally disintegrating tablets, they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1 000 patients. Body as a Whole: Cardiovascular Disorders: Central and Peripheral Nervous System Disorders: Gastrointestinal System Disorders: Hearing and Vestibular Disorders: Heart Rate and Rhythm Disorders: Metabolic and Nutritional Disorders: Musculoskeletal System Disorders: Platelet, Bleeding and Clotting Disorders: Psychiatric Disorders: Reproductive Disorders, Female: Reproductive Disorders, Male: Resistance Mechanism Disorders: Respiratory System Disorders: Skin and Appendages Disorders: Special Senses Other, Disorders: Urinary System Disorders: Vascular (Extracardiac) Disorders: Vision Disorders:.

Clonazepam orally disintegrating tablets are contraindicated in patients with the following conditions: History of sensitivity to benzodiazepines 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).

WARNINGS
Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including clonazepam orally disintegrating tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids 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 clonazepam orally disintegrating tablets 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. Advise both patients and caregivers about the risks of respiratory depression and sedation when clonazepam orally disintegrating tablets are used (see PRECAUTIONS: Information for Patients PRECAUTIONS: Drug Interactions Abuse, Misuse, and Addiction Abuse Before prescribing clonazepam orally disintegrating tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of clonazepam orally disintegrating tablets, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clonazepam orally disintegrating tablets along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions DOSAGE AND ADMINISTRATION Discontinuation or Dosage Reduction of Clonazepam Orally Disintegrating Tablets Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including clonazepam orally disintegrating tablets, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of clonazepam orally disintegrating tablets after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence Interference With Cognitive and Motor Performance: Since clonazepam orally disintegrating tablets 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. They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during clonazepam orally disintegrating tablets therapy (see PRECAUTIONS: Drug Interactions and Information for Patients Suicidal Behavior and Ideation: Pooled analyses of 199 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 1.8, 95% CI:1 .2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43% compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. 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 to100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs. Table 1 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events per 1,000 Patients Epilepsy 1 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 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 clonazepam orally disintegrating tablets 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 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. Neonatal Sedation and Withdrawal Syndrome:
OVERDOSAGE
Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-222-1222), poisoncontrol.org, or a medical toxicologist for additional overdosage management recommendations.
Medication Guide
Clonazepam ODT (Kloe-NA-za-pam) Orally Disintegrating Tablets, USP (ODT) CIV What is the most important information I should know about Clonazepam ODT? CLONAZEPAM ODT is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking CLONAZEPAM ODT with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including CLONAZEPAM ODT, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including CLONAZEPAM ODT. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take CLONAZEPAM ODT exactly as prescribed by your healthcare provider. Take CLONAZEPAM ODT exactly as your healthcare provider prescribed. Do not share your CLONAZEPAM ODT with other people. Keep CLONAZEPAM ODT in a safe place and away from children. Physical dependence and withdrawal reactions. Do not suddenly stop taking CLONAZEPAM ODT. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms. Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, 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. Do not take more CLONAZEPAM ODT than prescribed or take CLONAZEPAM ODT for longer than prescribed. CLONAZEPAM ODT 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 CLONAZEPAM ODT affects you. CLONAZEPAM ODT 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 CLONAZEPAM ODT until you talk to your healthcare provider. Like other antiepileptic medicines, CLONAZEPAM ODT 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 attempts 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 ODT without first talking to a healthcare provider. Stopping CLONAZEPAM ODT suddenly can cause serious problems. Stopping CLONAZEPAM ODT suddenly can cause seizures that will not stop (status epilepticus). What is CLONAZEPAM ODT? CLONAZEPAM ODT 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 CLONAZEPAM ODT is a federally controlled substance (C-IV) because if contains clonazepam that can be abused or lead to dependence. It is not known if CLONAZEPAM ODT is safe or effective in treating panic disorder in children younger than 18 years old. Do not take CLONAZEPAM ODT 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 CLONAZEPAM ODT, 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 are pregnant or plan to become pregnant. Taking CLONAZEPAM ODT late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems). Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CLONAZEPAM ODT. If you become pregnant while taking CLONAZEPAM ODT, 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. are breastfeeding or plan to breastfeed. Clonazepam can pass into your breast milk. Breastfeeding during treatment with CLONAZEPAM ODT may cause your baby to have sleepiness, feeding problems, and decreased weight gain. Talk to your healthcare provider about the best way to feed your baby while you take CLONAZEPAM ODT. Tell your healthcare provider about all the medicines you take, Taking CLONAZEPAM ODT with certain other medicines can cause side effects or affect how well CLONAZEPAM ODT or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. How should I take CLONAZEPAM ODT? Take CLONAZEPAM ODT exactly as your healthcare provider tells you. CLONAZEPAM is available as a tablet or as an orally disintegrating tablet. Do not stop taking CLONAZEPAM ODT without first talking to your healthcare provider. Stopping CLONAZEPAM ODT suddenly can cause serious problems. CLONAZEPAM ODT can be taken with or without water. After opening the bottle, with dry hands, take the orally disintegrating tablet and place it in your mouth. The orally disintegrating tablet will melt quickly. If you take too much CLONAZEPAM ODT, call your healthcare provider or local Poison Control Center right away. What should I avoid while taking CLONAZEPAM ODT? CLONAZEPAM ODT can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how CLONAZEPAM ODT affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking CLONAZEPAM ODT until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, CLONAZEPAM ODT may make your sleepiness or dizziness much worse. What are the possible side effects of CLONAZEPAM ODT? See “What is the most important information I should know about CLONAZEPAM ODT?” CLONAZEPAM ODT 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 ODT. The most common side effects of CLONAZEPAM ODT include: Drowsiness Dizziness Fatigue problems with walking and coordination depression problems with memory These are not all the possible side effects of CLONAZEPAM ODT. 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555. How should I store CLONAZEPAM ODT? Store clonazepam orally disintegrating tablets at 20° to 25°C (68° to 77°F); excursions permitted 15°to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep CLONAZEPAM ODT and all medicines out of the reach of children. General information about the safe and effective use of CLONAZEPAM ODT. You can ask your pharmacist or healthcare provider for information about CLONAZEPAM ODT that is written for health professionals. What are the ingredients in CLONAZEPAM ODT? Active ingredient: Inactive ingredients: Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512 For more information, go to www.sunpharma.com or call 1-800-818-4555. This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 08/2022

Sun Pharmaceutical Industries, Inc.

CLONAZEPAM- clonazepam_tablet, orally disintegrating Product manual source documgent