HomeNDC LookupIngredientsClonazepam › 71335-2509-09
Clonazepam .5 mg Tablet, 45-count — NDC 71335-2509-09 package photo

Clonazepam .5 mg Tablet, 45-count

by Bryant Ranch Prepack · 45 TABLET in 1 BOTTLE (71335-2509-9)
NDC 71335-2509-09
🏷️ FDA NDC (as labeled) 71335-2509-9 billing pads the package segment with a zero
This package
Contains45-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.0628/unit — full pricing hub ↓
Rx only Generic On market CIV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-2509-9
Product NDC 71335-2509
11-digit billing NDC 71335250909
RxCUI 197527
UNII 5PE9FDE8GB
Application # ANDA075468
SPL Set ID c4b87c17-efcd-4b66-96e7-159a04c808b5
Established class (EPC) Benzodiazepine
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-14
Route ORAL
Dosage form TABLET
Substance CLONAZEPAM
GCN Seq No 004560
GCN 17470
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 0.5 MG TABLET
FDB brand name Clonazepam
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71335-2509-9 — a 5-4-1 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 package segment → 71335-2509-09. 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.

🏷️ RxNorm drug class

This medicine belongs to the Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderRUBICON RESEARCH LTD
FDA applicationANDA075468 (ANDA)
Labeler code71335
First marketedApr 2022
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio4,433 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 0.5 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.

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.

💊 What it looks like

Color orange
ShapeRound
ImprintUpArrowhead;66
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII R95B8J264J
    Polyethylene glycol 200 is a clear, colorless liquid made from petroleum. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture to keep the product stable.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 · Q2 2026 $0.0628 $2.83 / 45 tablets
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 .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 mgthis 71335-2509-09 Bryant 45 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 mg 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
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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
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
71335-2509-01 20 TABLET in 1 BOTTLE (71335-2509-1) 2024-10-21 Active
71335-2509-02 30 TABLET in 1 BOTTLE (71335-2509-2) 2024-10-21 Active
71335-2509-03 60 TABLET in 1 BOTTLE (71335-2509-3) 2024-10-21 Active
71335-2509-04 90 TABLET in 1 BOTTLE (71335-2509-4) 2024-10-21 Active
71335-2509-05 120 TABLET in 1 BOTTLE (71335-2509-5) 2024-10-21 Active
71335-2509-06 56 TABLET in 1 BOTTLE (71335-2509-6) 2024-10-21 Active
71335-2509-07 28 TABLET in 1 BOTTLE (71335-2509-7) 2024-10-21 Active
71335-2509-08 100 TABLET in 1 BOTTLE (71335-2509-8) 2024-10-21 Active
71335-2509-09 You're viewing this 45 TABLET in 1 BOTTLE (71335-2509-9) 2024-10-21 Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2509-09?
NDC 71335-2509-09 is a 45-count package — 45 tablet in 1 bottle.
What is the difference between NDC 71335-2509-09 and NDC 71335-2509-01?
Both are Clonazepam .5 mg Tablet — the drug itself is identical. NDC 71335-2509-09 is the 45-count package, while NDC 71335-2509-01 is the 20 tablets package.
What NDC number is used to bill for this package of Clonazepam .5 mg Tablet?
Bill NDC 71335-2509-09 — the 11-digit billing format is 71335250909. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
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 71335-2509-9, 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: 71335-2509-09, written without dashes as 71335250909. 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 71335-2509-09, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2509) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 20 tablets (71335-2509-01), 28 tablets (71335-2509-07), 30 tablets (71335-2509-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
🚨 Boxed Warning 217 words

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 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 tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including clonazepam 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 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 tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).

🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE Seizure Disorders: Clonazepam tablets 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 tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ).

Panic Disorder: Clonazepam tablets are 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 tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR 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 tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).

⏱️ Dosage and Administration ~3 min read

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 tablets 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 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 tablets are 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 tablets in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of clonazepam tablets and observed closely (see PRECAUTIONS, Geriatric Use ) .

Panic Disorder: Adults: The initial dose for adults with panic disorder is 0.25 mg twice daily. 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 twice daily 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 tablets 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 tablets in panic disorder patients under 18 years of age. Geriatric Patients: There is no clinical trial experience with clonazepam tablets 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 ) .

Discontinuation or Dosage Reduction of clonazepam tablets: To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue clonazepam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ) .

Contraindications 43 words

CONTRAINDICATIONS Clonazepam 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 ~3 min read

WARNINGS Risks from Concomitant Use With Opioids: Concomitant use of benzodiazepines, including clonazepam tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe clonazepam tablets concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when clonazepam tablets are used with opioids (see PRECAUTIONS; Information for Patients and PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction: The use of benzodiazepines, including clonazepam tablets, 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 tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).

Use of clonazepam tablets, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of clonazepam tablets along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

Dependence and Withdrawal Reactions: To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clonazepam tablets 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 Tablets ) . Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had long durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including clonazepam tablets, may lead to clinically significant physical dependence.

Abrupt discontinuation or rapid dosage reduction of clonazepam tablets after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: Dependence ). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence ) . Interference With Cognitive and Motor Performance: Since clonazepam tablets produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle.

They should also be warned about the concomitant use of alcohol or other CNS-depressant drugs during clonazepam tablets therapy (see PRECAUTIONS, Drug Interactions and In…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS The adverse experiences for clonazepam tablets are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders: The most frequently occurring side effects of clonazepam tablets are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%.

In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of clonazepam tablets are: Cardiovascular: Palpitations Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums Genitourinary: Dysuria, enuresis, nocturia, urinary retention Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase Musculoskeletal: Muscle weakness, pains Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia, dysarthria, dysdiadochokinesis, “glassy-eyed” appearance, headache, hemiparesis, hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis (the behavior effects are more likely to occur in patients with a history of psychiatric disturbances).

The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams Respiratory : Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages Panic Disorder: Adverse events during exposure to clonazepam tablets 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 tablets 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 tablets than that of placebo included the following: Table 2 Most Common Adverse Events (≥1%) Associated with Discontinuation of Treatment Adverse Event Clonazepam Orally Disintegrating Tablets (N=574) Placebo (N=294) Somnolence 7% 1% Depression 4% 1% Dizziness 1% <1% Nervousness 1% 0% Ataxia 1% 0% Intellectual Ability Reduced 1% 0% Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam Tablets-Treated Patients : Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials.

Events reported in 1%…

🔄 Drug Interactions ~2 min read

Drug Interactions: Effect of Concomitant Use of Benzodiazepine and Opioids: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.

Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation. Effect of Clonazepam on the Pharmacokinetics of Other Drugs: Clonazepam does not appear to alter the pharmacokinetics of carbamazepine or phenobarbital. Clonazepam has the potential to influence concentrations of phenytoin.

Monitoring of phenytoin concentration is recommended when clonazepam is co-administrated with phenytoin. The effect of clonazepam on the metabolism of other drugs has not been investigated. Effect of Other Drugs on the Pharmacokinetics of Clonazepam: Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics.

In a study in which the 2 mg clonazepam tablet was administered with and without propantheline (an anticholinergic agent with multiple effects on the GI tract) to healthy volunteers, the AUC of clonazepam was 10% lower and the Cmax of clonazepam was 20% lower when the tablet was given with propantheline compared to when it was given alone. The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam.

Cytochrome P450 inducers, such as phenytoin, carbamazepine, lamotrigine, and phenobarbital induce clonazepam metabolism, causing an approximately 38% decrease in plasma clonazepam levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents (e.g., fluconazole), should be used cautiously in patients receiving clonazepam because they may impair the metabolism of clonazepam leading to exaggerated concentrations and effects.

Pharmacodynamic Interactions: The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors and the tricyclic antidepressants, and by other anticonvulsant drugs. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis Carcinogenicity studies have not been conducted with clonazepam. Mutagenesis The data currently available are not sufficient to determine the genotoxic potential of clonazepam.

Impairment of Fertility In a two-generation fertility study in which clonazepam was given orally to rats at 10 and 100 mg/kg/day, there was a decrease in the number of pregnancies and in the number of offspring surviving until weaning. The lowest dose tested is approximately 5 and 24 times the maximum recommended human dose (MRHD) of 20 mg/day for seizure disorders and 4 mg/day for panic disorder, respectively, on a body surface area (mg/m 2 ). Pregnancy: There are no adequate and well-controlled studies of clonazepam tablets in pregnant women.

Available human data on the risk of teratogenicity are inconclusive. There is insufficient evidence in humans to assess the effect of benzodiazepine exposure during pregnancy on neurodevelopment. Administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding.

In addition, infants born to mothers who have…

🤰 Pregnancy ~3 min read

Pregnancy: There are no adequate and well-controlled studies of clonazepam tablets in pregnant women. Available human data on the risk of teratogenicity are inconclusive. There is insufficient evidence in humans to assess the effect of benzodiazepine exposure during pregnancy on neurodevelopment.

Administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding. In addition, infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period. In three studies in which clonazepam was administered orally to pregnant rabbits at doses of 0.2, 1, 5, or 10 mg/kg/day during the period of organogenesis, a similar pattern of malformations (cleft palate, open eyelid, fused sternebrae and limb defects) was observed at all doses, in a low, non-dose-related incidence.

The lowest dose tested is less than the maximum recommended human dose (MRHD) of 20 mg/day for seizure disorders and similar to the MRHD of 4 mg/day for panic disorder, on a mg/m 2 basis. Reductions in maternal weight gain occurred at doses of 5 mg/kg/day or greater and reduction in embryofetal growth occurred in one study at a dose of 10 mg/kg/day. No adverse maternal or embryofetal effects were observed in mice or rats following oral administration of clonazepam during organogenesis of doses up to 15 or 40 mg/kg/day, respectively (4 and 20 times the MRHD of 20 mg/day for seizure disorders and 20 and 100 times the MRHD of 4 mg/day for panic disorder, respectively, on a mg/m 2 basis).

Data for other benzodiazepines suggest the possibility of adverse developmental effects (long-term effects on neurobehavioral and immunological function) in animals following prenatal exposure to benzodiazepines. To provide information regarding the effects of in utero exposure to clonazepam tablets, physicians are advised to recommend that pregnant patients taking clonazepam enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.

Information on this registry can also be found at the website http://www.aedpregnancyregistry.org/. Labor and Delivery: The effect of clonazepam tablets on labor and delivery in humans has not been specifically studied; however, perinatal complications have been reported in children born to mothers who have been receiving benzodiazepines late in pregnancy, including findings suggestive of either excess benzodiazepine exposure or of withdrawal phenomena (see WARNINGS, Pregnancy Risks ) . Nursing Mothers: The effects of clonazepam tablets on the breastfed infant and on milk production are unknown.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clonazepam tablets and any potential adverse effects on the breastfed infant from the underlying maternal condition. Pediatric Use: Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of clonazepam tablet is important in pediatric patients being treated for seizure disorder (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ) .

Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established. Geriatric Use: Clinical studies of clonazepam tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac f…

🧒 Pediatric Use ~1 min read

Pediatric Use: Because of the possibility that adverse effects on physical or mental development could become apparent only after many years, a benefit-risk consideration of the long-term use of clonazepam tablet is important in pediatric patients being treated for seizure disorder (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ) . Safety and effectiveness in pediatric patients with panic disorder below the age of 18 have not been established. Geriatric Use: Clinical studies of clonazepam tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Because clonazepam undergoes hepatic metabolism, it is possible that liver disease will impair clonazepam tablets elimination.

Metabolites of clonazepam tablets are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of clonazepam tablets and observed closely.

🧓 Geriatric Use 191 words

Geriatric Use: Clinical studies of clonazepam tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because clonazepam undergoes hepatic metabolism, it is possible that liver disease will impair clonazepam tablets elimination. Metabolites of clonazepam tablets are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function. Because elderly patients are more likely to have decreased hepatic and/or renal function, care should be taken in dose selection, and it may be useful to assess hepatic and/or renal function at the time of dose selection.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of clonazepam tablets and observed closely.

🆘 Overdosage ~1 min read

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 ~3 min read

CLINICAL PHARMACOLOGY Pharmacodynamics: The precise mechanism by which clonazepam exerts its anti-seizure and anti-panic 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 tablets 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-lllR) with or without agoraphobia. In these studies, clonazepam tablets were 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 tablets doses of 0.5, 1, 2, 3 or 4 mg/day or placebo. This study was conducted in four phases: a 1-week placebo lead-in, a 3- week upward titration, a 6-week fixed dose and a 7-week discontinuance phase. A significant difference from placebo was observed consistently only for the 1 mg/day group.

The difference between the 1 mg dose group and placebo in reduction from baseline in the number of full panic attacks was approximately 1 panic attack per week. At endpoint, 74% of patients receiving clonazepam 1 mg/day were free of full panic attacks, compared to 56% of placebo-treated patients. Study 2 was a 6-week, flexible-dose study involving clonazepam tablets in a dose range of 0.5 to 4 mg/day or placebo.

This study was conducted in three phases: a 1-week placebo lead- in, a 6-week optimal-dose and a 6-week discontinuance phase. The mean clonazepam dose during the optimal dosing period was 2.3 mg/day. The difference between clonazepam tablets and placebo in reduction from baseline in the number of full panic attacks was approximately 1 panic attack per week.

At endpoint, 62% of patients receiving clonazepam were free of full panic attacks, compared to 37% of placebo-treated patients. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of race or gender.

📦 How Supplied / Storage and Handling 110 words

HOW SUPPLIED Clonazepam Tablets USP, 0.5 mg are mottled orange, round, flat-faced, beveled edge tablet, debossed with Λ on one side and scored on the other side. NDC: 71335-2509-1: 20 Tablets in a BOTTLE NDC: 71335-2509-2: 30 Tablets in a BOTTLE NDC: 71335-2509-3: 60 Tablets in a BOTTLE NDC: 71335-2509-4: 90 Tablets in a BOTTLE NDC: 71335-2509-5: 120 Tablets in a BOTTLE NDC: 71335-2509-6: 56 Tablets in a BOTTLE NDC: 71335-2509-7: 28 Tablets in a BOTTLE NDC: 71335-2509-8: 100 Tablets in a BOTTLE NDC: 71335-2509-9: 45 Tablets in a BOTTLE Store at 20°C to 25°C (68°F -77°F) [See USP Controlled Room Temperature].

Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 114 words

DESCRIPTION Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ and Λ containing 1 mg or 2 mg of clonazepam respectively. Each tablet also contains lactose monohydrate, polyethylene 66 67 69 glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, with the following colourants: 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H -1,4-benzodiazepin-2-one.

It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

💬 Information for Patients ~3 min read

Information for Patients: A clonazepam tablets Medication Guide must be given to the patient each time clonazepam tablets are dispensed, as required by law. Patients should be instructed to take clonazepam tablets only as prescribed. Physicians are advised to discuss the following issues with patients for whom they prescribe clonazepam tablets.

Risks from Concomitant Use With Opioids Inform patients and caregivers that potentially fatal additive effects may occur if clonazepam is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider (see WARNINGS: Risks from Concomitant Use With Opioids and PRECAUTIONS: Drug Interactions ) . Abuse, Misuse, and Addiction: Inform patients that the use of clonazepam tablets, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances .

Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS: Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE ) Withdrawal Reactions: Inform patients that the continued use of clonazepam tablets may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of clonazepam tablets may precipitate acute withdrawal reactions, which can be life-threatening.

Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of clonazepam tablets may require a slow taper (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE ). Interference With Cognitive and Motor Performance : Because benzodiazepines have the potential to impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that clonazepam tablets therapy does not affect them adversely.

Suicidal Thinking and Behavior: Patients, their caregivers, and families should be counseled that AEDs, including clonazepam tablet, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with clonazepam tablets (see WARNINGS: Pregnancy Risks ).

Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy ) .

Nursing : Patients should be advised to notify their physician if they are breastfeeding or intend to breastfeed during therapy. Concomitant Medication: Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions. Alcohol: Patients should be advised to avoid alcohol while taking clonazepam tablets.

Drug Interactions: Effect of Concomitant Use of Benzodiazepine and Opioids: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites, a…

💬 Medication Guide ~3 min read

MEDICATION GUIDECLONAZEPAM (kloe NAZ e pam) tablet, for oral use, C-IV What is the most important information I should know about clonazepam tablets? Clonazepam 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 tablets with opioids affects you. Risk of abuse, misuse, and addiction . There is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam tablet 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 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 tablets as prescribed by your healthcare provider. Take clonazepam tablets exactly as your healthcare provider prescribed. Do not share your clonazepam tablets with other people.

Keep clonazepam tablets in a safe place and away from children. Physical dependence and withdrawal reactions. Clonazepam tablets can cause physical dependence and withdrawal reactions.

Do not suddenly stop taking clonazepam tablets . Stopping clonazepam 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 tablets than prescribed or take clonazepam tablets for longer than prescribed. 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 tablets 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 ◦ feeling…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.