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CLONAZEPAM 1 mg Tablet, 30-count

by DIRECT RX · 30 TABLET in 1 BOTTLE (61919-485-30)
NDC 61919-0485-30
🏷️ FDA NDC (as labeled) 61919-485-30 billing pads the product segment with a zero
Rx only Generic Discontinued CIV ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Clonazepam (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0179-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0181-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0178-2025
Class I · Nov 18, 2024 — Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. (Endo USA, Inc.) · FDA recall D-0180-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-485-30
Product NDC 61919-485
11-digit billing NDC 61919048530
NCPDP billing unit EA — each (per item)
Application # ANDA077147
SPL Set ID 78f87e87-6d36-4ee8-9d2d-ec75666c71ce
Chemical class Benzodiazepine [EPC], Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form TABLET
Substance CLONAZEPAM
GCN Seq No 004561
GCN 17471
HICL code 001894
Ingredient (HICL) Clonazepam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4A
Therapeutic class — specific (HIC3) Anticonvulsant - Benzodiazepine Type
AHFS code 28:12.08.00
AHFS class Benzodiazepines (Anticonvulsants)
FDB label name CLONAZEPAM 1 MG TABLET
FDB brand name Clonazepam
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-485-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0485-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerDIRECT RX
Application holderACCORD HEALTHCARE INC
FDA applicationANDA077147 (ANDA)
Labeler code61919
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio204 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CLONAZEPAM 1 MG TABLET Ingredient Clonazepam
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Clonazepam guide →
1
Nutrient depletion considerations

Clonazepam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clonazepam nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clonazepam 1 mg 00093-3212-01 Teva 100 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 00904-7728-61 Major 100 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 16729-0137-00 Accord 100 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 43547-0407-10 Solco 100 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 50268-0174-15 AvPAK 50 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 59651-0723-01 Aurobindo 100 tablets $0.025 — Availability likely —
Clonazepam 1 mg 60687-0872-01 American 100 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 62135-0770-90 Chartwell 90 tablets $0.025 AB Availability likely —
Clonazepam 1 mg 72603-0308-01 Northstar 100 tablets $0.025 — Availability likely —
Clonazepam 1 mg 72888-0153-00 Advagen 1000 tablets $0.025 — Availability likely —
Klonopin 1 mg 61269-0610-10 H2-Pharma, 100 tablets $3.050 AB Availability likely —
Clonazepam 1 mg 43063-0794-30 PD-Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 50090-2022-00 A-S 60 tablets — AB Discontinued —
Clonazepam 1 mg 55154-4319-00 Cardinal 100 tablets — AB FDA listed —
Clonazepam 1 mg 58118-0153-08 Clinical 30 tablets — — FDA listed —
Clonazepam 1 mg 60760-0300-30 St 30 tablets — AB FDA listed —
Clonazepam 1 mg 63187-0888-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 63629-1116-01 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 63629-1204-01 Bryant 500 tablets — AB Discontinued —
Clonazepam 1 mg 63629-1205-01 Bryant 1000 tablets — AB FDA listed —
Clonazepam 1 mg 63629-8988-01 Bryant 30 tablets — AB FDA listed —
Clonazepam 1 mg 67046-0493-03 Coupler 30 tablets — AB FDA listed —
Clonazepam 1 mg 67046-0794-03 Coupler 30 tablets — AB FDA listed —
Clonazepam 1 mg 68071-5247-09 NuCare 90 tablets — AB FDA listed —
Clonazepam 1 mg 68788-8401-02 Preferred 20 tablets — AB FDA listed —
Clonazepam 1 mg 68788-8473-02 Preferred 20 tablets — — FDA listed —
Clonazepam 1 mg 70518-1521-01 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-2334-00 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-2533-00 REMEDYREPACK 30 tablets — AB Discontinued —
Clonazepam 1 mg 70518-3144-00 REMEDYREPACK 100 tablets — AB FDA listed —
Clonazepam 1 mg 70518-4074-00 REMEDYREPACK 30 tablets — AB FDA listed —
Clonazepam 1 mg 71205-0529-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 71335-0022-00 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 71335-1843-00 Bryant 100 tablets — AB FDA listed —
Clonazepam 1 mg 71335-2414-00 Bryant 100 tablets — — FDA listed —
Clonazepam 1 mg 71610-0040-30 Aphena 30 tablets — AB FDA listed —
Clonazepam 1 mg 71610-0771-15 Aphena 15 tablets — AB FDA listed —
Clonazepam 1 mg 71610-0852-12 Aphena 12 tablets — AB FDA listed —
Clonazepam 1 mg 72189-0475-30 Direct_Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 72789-0314-30 PD-Rx 30 tablets — AB FDA listed —
Clonazepam 1 mg 80425-0135-01 Advanced 30 tablets — AB FDA listed —
Clonazepam 1 mg 80425-0357-01 Advanced 30 tablets — AB FDA listed —
Clonazepam 1 mg 82804-0272-30 Proficient 30 tablets — AB FDA listed —
Clonazepam 1 mg 87441-0022-01 Unit 30 tablets — — FDA listed —
Clonazepam 1 mgthis 61919-0485-30 DIRECT 30 tablets — AB Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clonazepam — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clonazepam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.53M
Claims incl. refills
2.1M
Beneficiaries
936.4K
Spend / beneficiary
$16.58
Spend / claim
$7.45
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Clonazepam — the ingredient across all brands.

Top reported reactions

Fatigue10,473
Nausea9,818
Anxiety8,896
Headache8,763
Depression8,232
Pain8,226
Dizziness7,402

Age at onset

Neonate212
Infant161
Child399
Adolescent334
Adult12,315
Elderly4,853

Reporter sex

0 reports

Serious outcomes

Hospitalization47,319
Death18,608
Life-threatening6,316
Disabling4,481
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,027 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0485-30 You're viewing this 30 TABLET in 1 BOTTLE (61919-485-30) 2018-03-14 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61919-485-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61919-0485-30, written without dashes as 61919048530. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61919-0485-30, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0485) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
DIRECT RX is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🎯 Indications and Usage ~1 min read ▾

INDICATIONS & USAGE SECTION Seizure Disorders: Clonazepam tablets, USP are 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. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration.

In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. 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 CLlNICAL PHARMACOLOGY: Clinical Trials ). Panic disorder (DSM-IV) 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 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 ~2 min read ▾

DOSAGE & ADMINISTRATION SECTION Clonazepam tablets should be administered with water by swallowing the tablet whole. Seizure Disorders: Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase.

Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg. The use of multiple anticonvulsants may result in an increase of depressant adverse effects.

This should be considered before adding clonazepam to an existing anticonvulsant regimen. 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 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 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 51 words ▾

CONTRAINDICATIONS SECTION Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow angle glaucoma.

⚠️ Warnings ~3 min read ▾

WARNINGS SECTION 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 clonazepam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.

Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. 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 Drug Patients with Relative Risk: Risk Difference: with Events Per Events Per 1000 Incidence of Events Additional Drug 1000 Patients Patients in Drug Patients with Events Patients/Incidence per 1000 Patients in Placebo Patients Epilepsy 1 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The 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 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 suicid…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS SECTION 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, are: 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. 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.

Musculoskeletal: Muscle weakness, pains. Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain. Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia.

Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase. 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 for which the incidence was greater than that in p…

🆘 Overdosage ~1 min read ▾

OVERDOSAGE SECTION 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 ~3 min read ▾

CLINICAL PHARMACOLOGY SECTION 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.

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.

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…

📦 How Supplied / Storage and Handling 108 words ▾

HOW SUPPLIED SECTION Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. 1 mg — Each yellow, round tablet imprinted and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. 2 mg — Each white, round tablet imprinted and 35 on one side and scored on the other side contains 2 mg of clonazepam USP.

Store at 25(C (77(F); excursions permitted to 15( to 30(C (59( to 86(F). Dispense in tight, light-resistant containers as defined in the USP.

📋 Description 90 words ▾

DESCRIPTION SECTION Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake.

The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(o-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: image description

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE SECTION CLONAZEPAM TABLETS, USP CIV Rx only Read this Medication Guide before you start taking clonazepam and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Clonazepam can cause serious side effects. Because stopping clonazepam suddenly can also cause serious problems, do not stop taking clonazepam without talking to your healthcare provider first. What is the most important information I should know about clonazepam?

Do not stop taking clonazepam without first talking to your healthcare provider. Stopping clonazepam suddenly can cause serious problems. Clonazepam can cause serious side effects, including: 1.

Clonazepam can slow your thinking and motor skills •Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam affects you.•Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam 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.2.Like other antiepileptic drugs, clonazepam may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: •thoughts about suicide or dying•attempt to commit suicide•new or worse depression•new or worse anxiety•feeling agitated or restless•panic attacks•trouble sleeping (insomnia)•new or worse irritability•acting aggressive, being angry, or violent•acting on dangerous impulses•an extreme increase in activity and talking (mania)•other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? •Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.•Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not stop clonazepam without first talking to a healthcare provider. Stopping clonazepam suddenly can cause serious problems. Stopping clonazepam suddenly can cause seizures that will not stop (status epilepticus).

3. Clonazepam may harm your unborn or developing baby. •If you take clonazepam 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 clonazepam) 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 clonazepam. You and your healthcare provider should decide if you will take clonazepam while you are pregnant.•If you become pregnant while taking clonazepam, 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.•Clonazepam can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clonazepam.

You and your healthcare provider should decide if you will take clonazepam or breast feed. You should not do both. 4.

Clonazepam can cause abuse and dependence. •Do not stop taking clonazepam all of a sudden. Stopping…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.