Clonazepam .5 mg Tablet, 30-count
Other active recalls for Clonazepam (different manufacturers) — 4 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Benzodiazepine class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Clonazepam is used to control certain types of seizures. It is also used to treat 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.
Read the full MedlinePlus article ↗- Clonazepam is used for two main things: certain types of seizures and panic disorder. On the seizure side, it's approved for Lennox-Gastaut syndrome, akinetic seizures, myoclonic s...
- It's a fair concern, and the honest answer is yes — clonazepam can cause physical dependence with regular use, and there is a real risk of misuse and addiction. This doesn't mean e...
- Is it true clonazepam is addictive? Should I be worried?
- Drowsiness is the big one — about half of people taking it for seizures experience it. Problems with balance or coordination (called ataxia) are also common. You might also notice...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clonazepam — tap one for details:
Clonazepam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.0628 | $1.88 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clonazepam .5 mg 00093-0832-01 | Teva | 100 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 00904-7227-61 | Major | 100 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 16729-0136-00 | Accord | 100 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 43547-0406-10 | Solco | 100 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 50268-0173-15 | AvPAK | 50 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 59651-0722-01 | Aurobindo | 100 tablets | $0.020 | — | Availability likely | — |
| Clonazepam .5 mg 60687-0861-01 | American | 100 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 62135-0769-90 | Chartwell | 90 tablets | $0.020 | AB | Availability likely | — |
| Clonazepam .5 mg 72603-0307-01 | Northstar | 100 tablets | $0.020 | — | Availability likely | — |
| Clonazepam .5 mg 72888-0152-00 | Advagen | 1000 tablets | $0.020 | — | Availability likely | — |
| Klonopin .5 mg 61269-0605-10 | H2-Pharma, | 100 tablets | $2.671 | AB | Availability likely | — |
| Clonazepam .5 mg 43063-0797-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 50090-2088-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 50090-4841-02 | A-S | 90 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 55154-4318-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 58118-0152-08 | Clinical | 30 tablets | — | — | FDA listed | — |
| Clonazepam .5 mg 58118-0832-08 | Clinical | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 63187-0226-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 63187-0603-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 63629-1201-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 63629-1202-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 63629-1203-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 67046-1521-03 | Coupler | 30 tablets | — | — | FDA listed | — |
| Clonazepam .5 mg 67544-0529-15 | Aphena | 15 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 68071-4021-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 68788-8420-02 | Preferred | 20 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 70518-1297-01 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 70518-1801-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 70518-2507-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 70518-3891-00 | REMEDYREPACK | 30 tablets | — | — | FDA listed | — |
| Clonazepam .5 mg 70518-3960-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71205-0827-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71335-0113-01 | Bryant | 20 tablets | — | AB | Discontinued | — |
| Clonazepam .5 mg 71335-1810-01 | Bryant | 20 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71335-2509-01 | Bryant | 20 tablets | — | — | FDA listed | — |
| Clonazepam .5 mg 71610-0039-45 | Aphena | 45 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71610-0368-10 | Aphena | 10 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71610-0790-10 | Aphena | 10 tablets | — | — | FDA listed | — |
| Clonazepam .5 mg 71610-0855-10 | Aphena | 10 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 71610-0863-10 | Aphena | 10 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 72162-1364-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 72189-0081-30 | DIRECT | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 72789-0307-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mgthis 80425-0125-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 80425-0358-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 80425-0402-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Clonazepam .5 mg 87441-0021-01 | Unit | 30 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80425-0125-01 You're viewing this | 30 TABLET in 1 BOTTLE (80425-0125-1) | 2011-06-03 | Active |
| 80425-0125-02 | 60 TABLET in 1 BOTTLE (80425-0125-2) | 2011-06-03 | Active |
| 80425-0125-03 | 90 TABLET in 1 BOTTLE (80425-0125-3) | 2011-06-03 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 80425-0125-01?
What is the difference between NDC 80425-0125-01 and NDC 80425-0125-02?
What NDC number is used to bill for this package of Clonazepam .5 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
Boxed Warning WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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, 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 and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS) The continued use of benzodiazepines, including clonazepam, 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 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 or reduce the dosage DOSAGE AND ADMINISTRATION)
🎯 Indications and Usage ▾
Indications and Usage Section INDICATIONS AND USAGE Seizure Disorders: Clonazepam 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, clonazepam may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS : Loss of Effect).
Panic Disorder: Clonazepam 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 clonazepam 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, i.e., 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 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 for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
⏱️ Dosage and Administration ▾
Dosage and Administration Section DOSAGE AND ADMINISTRATION Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole. Seizure Disorders: The use of multiple anticonvulsants may result in an increase of CNS depressant adverse effects.
This should be considered before adding clonazepam to an existing anticonvulsant regimen. 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 mg 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. Pediatric Patients: Clonazepam is administered orally.
In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 mg to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses.
If doses are not equally divided, the largest dose should be given before retiring. Geriatric Patients: There is no clinical trial experience with clonazepam in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: GERIATRIC USE).
Panic Disorder: Adults: The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day.
Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 mg to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn. There is no body of evidence available to answer the question of how long the patient treated with clonazepam should remain on it. Therefore, the physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Pediatric Patients: There is no clinical trial experience with clonazepam in panic disorder patients under 18 years of age. Geriatric Patients: There is no clinical trial experience with clonazepam in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam and observed closely (see PRECAUTIONS: GERIATRIC USE).
⛔ Contraindications ▾
Contraindications Clonazepam is 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 Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including clonazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use 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 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 is used with opioids (see PRECAUTIONS : INFORMATION FOR PATIENTS and PRECAUTIONS : DRUG INTERACTIONS). Abuse, Misuse, and Addiction: The use of benzodiazepines, including clonazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE: ABUSE). Before prescribing clonazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).
Use of clonazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clonazepam 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: To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of clonazepam). 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, may lead to clinically significant physical dependence.
Abrupt discontinuation or rapid dosage reduction of clonazepam 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 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 therapy (see PRECAUTIONS: DRUG INTERACTIONS and INFORMATION FOR PATIENTS). Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including clonaz…
🤒 Adverse Reactions ▾
Adverse Reactions The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders: The most frequently occurring side effects of clonazepam 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 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: irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares, abnormal dreams, hallucinations. Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages Panic Disorder: Adverse events during exposure to clonazepam were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories.
In the tables and tabulations that follow, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below. 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: Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6- to 9-week trials. The most common events (≥ 1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following: Table 2 Most Common Adverse Events (≥ 1%) Associated with Discontinuation of Treatment Adverse Event Clonazepam (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-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 (doses ranging from 0.5 to 4 mg/day) and fo…
🆘 Overdosage ▾
Overdosage Human Experience: Symptoms of clonazepam overdosage, like those produced by other CNS depressants, include somnolence, confusion, coma, and diminished reflexes. Overdose Management: Treatment includes monitoring of respiration, pulse and blood pressure, general supportive measures and immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained.
Hypotension may be combated by the use of levarterenol or metaraminol. Dialysis is of no known value. Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.
Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment.
The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, should be consulted prior to use. Flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines.
Antagonism of the benzodiazepine effect in such patients may provoke seizures. Serious sequelae are rare unless other drugs or alcohol have been taken concomitantly.
🧬 Clinical Pharmacology ▾
Clinical Pharmacology 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. 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.
Pharmacokinetics in Demographic Subpopulations and in Disease States: 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.
(see CONTRAINDICATIONS). In children, clearance values of 0.42 ± 0.32 mL/min/kg (ages 2 – 18 years) and 0.88 ± 0.4 mL/min/kg (ages 7 – 12 years) were reported; these values decreased with increasing body weight. Ketogenic diet in children does not affect clonazepam concentrations.
Clinical Trials: Panic Disorder: The effectiveness of clonazepam 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, clonazepam 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 clonazepam 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 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 clonazepam 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.
📦 How Supplied / Storage and Handling ▾
How Supplied/Storage and Handling Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 30: NDC 80425-0125-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA.
Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 0533 3 6007149 Issued February 2021
📋 Description ▾
Description Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake.
Chemically, clonazepam 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 a molecular weight of 315.72 and the following structural formula: Structure
💬 Medication Guide ▾
Medication Guide Section MEDICATION GUIDE Medication Guide Clonazepam Tablets, USP (kloe-NA-za-pam) CIV What is the most important information I should know about clonazepam tablets? • Clonazepam tablets is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines. •Clonazepam 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 tablets affects you. Clonazepam 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 tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam may make your sleepiness or dizziness worse.
Like other antiepileptic drugs, clonazepam 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 attempt to commit suicide new or worse depression new or worse anxiety trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. •Do not stop clonazepam tablets without first talking to a healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems.
Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus). •Clonazepam tablets can cause abuse and dependence. Do not stop taking clonazepam all of a sudden. Stopping clonazepam tablets suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
Talk to your healthcare provider about slowly stopping clonazepam tablets 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.
Clonazepam tablets is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep clonazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam tablets may harm others, and is against the law.
Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. What is Clonazepam tablets? Clonazepam tablets 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 clonazepam tablets is safe or effective in treating panic disorder in children younger than 18 years old.
Who should not take Clonazepam tablets? Do not take clonazepam tablets if you: are allergic to benzodiazepines have significant liver disease have an eye disease called acute narrow angle glaucoma Ask your healthcare provider if you are not sure if you have any of the problems listed above. Before you take clonazepam tablet…