Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Rx only
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
BOXED WARNING SECTION
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including clonazepam orally disintegrating tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clonazepam orally disintegrating tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ) . The continued use of benzodiazepines, including clonazepam orally disintegrating tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clonazepam orally disintegrating tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam orally disintegrating tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ) .
DESCRIPTION
DESCRIPTION SECTION
Clonazepam orally disintegrating tablets, USP a benzodiazepine, contains 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating tablet also contains the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Chemically, clonazepam, USP is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H -1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C 15 H 10 CIN 3 O 3 M.W. 315.72
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The adverse experiences for clonazepam orally disintegrating tablets are provided separately for patients with seizure disorders and with panic disorder.
DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
OVERDOSAGE
OVERDOSAGE SECTION
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 ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. 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 a poison center (1-800-222-1222), poisoncontrol.org, or a medical toxicologist for additional overdosage management recommendations.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
Clonazepam orally disintegrating tablets should be administered as follows: Peel back the foil on the blister. Do not push tablet through foil. Immediately upon opening the blister, 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.
HOW SUPPLIED
HOW SUPPLIED SECTION
Clonazepam orally disintegrating tablets, USP are available as: 0.125 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with stylized b over 94 on one side and 1/8 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0093-9290-67). 0.25 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with stylized b over 95 on one side and 1/4 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0093-9291-67). 0.5 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with stylized b over 96 on one side and 1/2 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0093-9292-67). 1 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with stylized b over 97 on one side and 1 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0093-9293-67). 2 mg: White to off-white, round, flat-faced, beveled-edge, unscored tablet. Debossed with stylized b over 98 on one side and 2 on the other side. Available in cartons of 60 blistered tablets (10 blister cards containing 6 blisters each) (NDC 0093-9294-67). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. O 5/2024
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Clonazepam (kloe naz′ e pam) Orally Disintegrating Tablets, C-IV What is the most important information I should know about clonazepam orally disintegrating tablets? Clonazepam orally disintegrating tablet 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. Get emergency help right away if any of the following happens: 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 orally disintegrating tablets with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam orally disintegrating tablets 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 orally disintegrating tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. 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 orally disintegrating tablets exactly as prescribed by your healthcare provider. Take clonazepam orally disintegrating tablets exactly as your healthcare provider prescribed. Do not share your clonazepam orally disintegrating tablets with other people. Keep clonazepam orally disintegrating tablets in a safe place and away from children. Physical dependence and withdrawal reactions. Clonazepam orally disintegrating tablets can cause physical dependence and withdrawal reactions, especially if you continue to take clonazepam orally disintegrating tablets for several days to several weeks. Do not suddenly stop taking clonazepam orally disintegrating tablets . Stopping clonazepam orally disintegrating tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. 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 , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. 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 orally disintegrating tablets than prescribed or take clonazepam orally disintegrating tablets for longer than prescribed. Clonazepam orally disintegrating tablets 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 orally disintegrating tablets affect you. Clonazepam orally disintegrating tablets 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 orally disintegrating tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam orally disintegrating tablets may make your sleepiness or dizziness worse. Like other antiepileptic medicines, clonazepam orally disintegrating tablets 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: 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 orally disintegrating tablets without first talking to a healthcare provider. Stopping clonazepam orally disintegrating tablets suddenly can cause serious problems. Stopping clonazepam orally disintegrating tablets suddenly can cause seizures that will not stop (status epilepticus). What is clonazepam orally disintegrating tablet? Clonazepam orally disintegrating tablet 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 orally disintegrating tablet is a federally controlled substance (C-IV) because it contains clonazepam that can be abused or lead to dependence. Keep clonazepam orally disintegrating tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam orally disintegrating tablets 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. It is not known if clonazepam orally disintegrating tablet is safe or effective in treating panic disorder in children younger than 18 years old. Do not take clonazepam orally disintegrating 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. Before you take clonazepam orally disintegrating tablets, 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 orally disintegrating tablets 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 orally disintegrating tablets. If you become pregnant while taking clonazepam orally disintegrating 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 anti...
Package/Label Display panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-9290-67 CIV Clonazepam Orally Disintegrating Tablets, USP 0.125 mg Each tablet contains 0.125 mg clonazepam, USP. Phenylketonurics: Contains phenylalanine 2.4 mg per tablet. Pharmacist: Dispense with the accompanying Medication Guide to each patient. Rx only 60 Tablets (10 blister cards of 6 tablets each)
Package/Label Display panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-9291-67 CIV Clonazepam Orally Disintegrating Tablets, USP 0.25 mg Each tablet contains 0.25 mg clonazepam, USP. Phenylketonurics: Contains phenylalanine 2.4 mg per tablet. Pharmacist: Dispense with the accompanying Medication Guide to each patient. Rx only 60 Tablets (10 blister cards of 6 tablets each)
Package/Label Display panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-9292-67 CIV Clonazepam Orally Disintegrating Tablets, USP 0.5 mg Each tablet contains 0.5 mg clonazepam, USP. Phenylketonurics: Contains phenylalanine 2.4 mg per tablet. Pharmacist: Dispense with the accompanying Medication Guide to each patient. Rx only 60 Tablets (10 blister cards of 6 tablets each)
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-9293-67 CIV Clonazepam Orally Disintegrating Tablets, USP 1 mg Each tablet contains 1 mg clonazepam, USP. Phenylketonurics: Contains phenylalanine 2.4 mg per tablet. Pharmacist: Dispense with the accompanying Medication Guide to each patient. Rx only 60 Tablets (10 blister cards of 6 tablets each)
Package/Label Display panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0093-9294-67 CIV Clonazepam Orally Disintegrating Tablets, USP 2 mg Each tablet contains 2 mg clonazepam, USP. Phenylketonurics: Contains phenylalanine 2.4 mg per tablet. Pharmacist: Dispense with the accompanying Medication Guide to each patient. Rx only 60 Tablets (10 blister cards of 6 tablets each)