HomeNDC LookupIngredientsLorazepam › 71610-0008-45
Lorazepam .5 mg Tablet, 45-count — NDC 71610-0008-45 package photo

Lorazepam .5 mg Tablet, 45-count

by Aphena Pharma Solutions - Tennessee, LLC · 45 TABLET in 1 BOTTLE (71610-008-45)
NDC 71610-0008-45
🏷️ FDA NDC (as labeled) 71610-008-45 billing pads the product segment with a zero
This package
Contains45-count Pack sizes11 compare ↓
Also priced by: Part D plans $0.1178/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 Lorazepam (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 22, 2025 — Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0551-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71610-008-45
Product NDC 71610-008
11-digit billing NDC 71610000845
NCPDP billing unit EA — each (per item)
RxCUI 197900
UNII O26FZP769L
Application # ANDA078203
SPL Set ID e83ae439-3fa5-453f-9073-4bf8c797df47
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 2009-10-09
Route ORAL
Dosage form TABLET
Substance LORAZEPAM
GPI-14 57100060000305
GPI class LORazepam
GCN Seq No 003757
GCN 14160
HICL code 004846
Ingredient (HICL) Lorazepam
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H20
Therapeutic class — specific (HIC3) Anti-Anxiety - Benzodiazepines
AHFS code 28:12.08.00
AHFS class Benzodiazepines (Anticonvulsants)
FDB label name LORAZEPAM 0.5 MG TABLET
FDB brand name Lorazepam
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 71610-008-45 — 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 → 71610-0008-45. 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderLEADING PHARMA LLC
FDA applicationANDA078203 (ANDA)
Labeler code71610
First marketedOct 2009
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio795 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 LORAZEPAM 0.5 MG TABLET Ingredient Lorazepam
📖 What it is MedlinePlus · NLM

Lorazepam is used to relieve anxiety and treat insomnia. Lorazepam is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow for relaxation.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lorazepam is mainly prescribed for anxiety disorders — it can calm anxious feelings and physical tension, especially for short periods. In tablet or liquid form, it's used for ongo...
  • Yes, drowsiness is one of the most common effects — and for many people that's actually part of how it helps with anxiety. You may also notice some unsteadiness, dizziness, or mild...
  • Will lorazepam make me feel really drowsy?
  • No — please avoid alcohol completely while you're on lorazepam. Both alcohol and lorazepam slow down your central nervous system, and together they can make that effect dangerously...
📖 Read our full Lorazepam guide →
1
Nutrient depletion considerations

Lorazepam 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 White
ShapeRound
ImprintEP;904
Size5 mm
ScoringNot scored
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 0BZ5A00FQU
    Polacrilin potassium is a synthetic polymer that absorbs water and swells. It acts as a disintegrant, helping tablets or capsules break apart quickly so the active ingredient can be absorbed in your body.

4 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 $0.1178 $5.30 / 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
Lorazepam .5 mg 00093-3425-01 Teva 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 13107-0083-01 Aurolife 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 60687-0820-01 American 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 62135-0861-01 Chartwell 100 tablets $0.033 Availability likely
Lorazepam .5 mg 63304-0772-01 SUN 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 64980-0627-01 Rising 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 69315-0904-01 Leading 100 tablets $0.033 AB Availability likely
Lorazepam .5 mg 00904-6007-60 Major 100 tablets $0.046 AB Discontinued
Ativan .5 mg 00187-0063-01 Bausch 100 tablets $32.865 AB FDA listed
Lorazepam .5 mg 51407-0996-01 Golden 100 tablets AB FDA listed
Lorazepam .5 mg 58118-0904-08 Clinical 30 tablets AB FDA listed
Lorazepam .5 mg 61919-0062-02 DIRECT 2 tablets AB FDA listed
Lorazepam .5 mg 62559-0195-01 ANI 100 tablets AB FDA listed
Lorazepam .5 mg 67046-0786-03 Coupler 30 tablets AB FDA listed
Lorazepam .5 mg 67296-1478-01 Redpharm 10 tablets AB Discontinued
Lorazepam .5 mg 67296-1629-01 RedPharm 10 tablets AB FDA listed
Lorazepam .5 mg 68071-3096-03 NuCare 30 tablets AB FDA listed
Lorazepam .5 mg 68071-3121-06 NuCare 6 tablets AB FDA listed
Lorazepam .5 mg 68071-3751-06 NuCare 60 tablets AB FDA listed
Lorazepam .5 mg 68071-4916-04 NuCare 45 tablets AB FDA listed
Lorazepam .5 mg 68071-5068-06 NuCare 6 tablets AB FDA listed
Lorazepam .5 mg 68788-7355-01 Preferred 100 tablets AB FDA listed
Lorazepam .5 mg 70518-1520-00 REMEDYREPACK 30 tablets AB FDA listed
Lorazepam .5 mg 70518-3806-00 REMEDYREPACK 30 tablets AB Discontinued
Lorazepam .5 mg 71205-0166-02 Proficient 2 tablets AB FDA listed
Lorazepam .5 mg 71205-0228-02 Proficient 2 tablets AB FDA listed
Lorazepam .5 mg 71205-0756-10 Proficient 10 tablets AB FDA listed
Lorazepam .5 mg 71335-0329-01 Bryant 30 tablets AB FDA listed
Lorazepam .5 mg 71335-1455-01 Bryant 30 tablets AB Discontinued
Lorazepam .5 mgthis 71610-0008-45 Aphena 45 tablets AB FDA listed
Lorazepam .5 mg 71610-0199-10 Aphena 10 tablets AB FDA listed
Lorazepam .5 mg 71610-0225-15 Aphena 15 tablets AB FDA listed
Lorazepam .5 mg 71610-0654-10 Aphena 10 tablets AB FDA listed
Lorazepam .5 mg 71610-0764-10 Aphena 10 tablets AB FDA listed
Lorazepam .5 mg 71610-0827-10 Aphena 10 tablets AB FDA listed
Lorazepam .5 mg 72189-0351-02 DirectRx 2 tablets AB FDA listed
Lorazepam .5 mg 72789-0236-30 PD-Rx 30 tablets AB FDA listed
Lorazepam .5 mg 72789-0355-30 PD-Rx 30 tablets AB FDA listed
Lorazepam .5 mg 76420-0647-01 Asclemed 100 tablets AB FDA listed
Lorazepam .5 mg 76420-0872-00 Asclemed 1000 tablets AB FDA listed
Lorazepam .5 mg 87441-0050-01 Unit 30 tablets AB FDA listed
Lorazepam .5 mg 60760-0947-02 St. 2 tablets AB 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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 Lorazepam — the program that covers self-administered drugs. 17 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 Lorazepam. 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
$17.62M
Claims incl. refills
1.9M
Beneficiaries
1M
Spend / beneficiary
$17.50
Spend / claim
$9.14
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 Lorazepam — the ingredient across all brands.

Top reported reactions

Fatigue13,822
Nausea13,647
Diarrhoea10,647
Dyspnoea9,489
Anxiety9,034
Headache8,908
Pain8,868

Age at onset

Neonate239
Infant146
Child366
Adolescent522
Adult13,566
Elderly8,384

Reporter sex

178,727 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization74,527
Death25,757
Life-threatening13,111
Disabling6,981
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,188 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
71610-0008-10 10 TABLET in 1 BOTTLE (71610-008-10) 2017-10-24 Active
71610-0008-15 15 TABLET in 1 BOTTLE (71610-008-15) 2017-10-24 Active
71610-0008-20 20 TABLET in 1 BOTTLE (71610-008-20) 2018-10-03 Active
71610-0008-30 30 TABLET in 1 BOTTLE (71610-008-30) 2017-10-24 Active
71610-0008-45 You're viewing this 45 TABLET in 1 BOTTLE (71610-008-45) 2017-10-24 Active
71610-0008-53 60 TABLET in 1 BOTTLE (71610-008-53) 2017-10-24 Active
71610-0008-60 90 TABLET in 1 BOTTLE (71610-008-60) 2017-10-24 Active
71610-0008-70 120 TABLET in 1 BOTTLE (71610-008-70) 2017-10-05 Active
71610-0008-75 150 TABLET in 1 BOTTLE (71610-008-75) 2018-10-17 Active
71610-0008-80 180 TABLET in 1 BOTTLE (71610-008-80) 2018-10-03 Active
71610-0008-92 270 TABLET in 1 BOTTLE (71610-008-92) 2018-06-27 Active

You're viewing one of 11 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0008-45?
NDC 71610-0008-45 is a 45-count package — 45 tablet in 1 bottle.
What is the difference between NDC 71610-0008-45 and NDC 71610-0008-10?
Both are Lorazepam .5 mg Tablet — the drug itself is identical. NDC 71610-0008-45 is the 45-count package, while NDC 71610-0008-10 is the 10 tablets package.
What NDC number is used to bill for this package of Lorazepam .5 mg Tablet?
Bill NDC 71610-0008-45 — the 11-digit billing format is 71610000845. 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 ✓ 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.
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 71610-008-45, 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: 71610-0008-45, written without dashes as 71610000845. 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 71610-0008-45, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0008) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) 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 Aphena Pharma Solutions - Tennessee, LLC. 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 10 other package presentations of this same product, including 10 tablets (71610-0008-10), 15 tablets (71610-0008-15), 20 tablets (71610-0008-20). 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?
Aphena Pharma Solutions - Tennessee, LLC 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 81 words

INDICATIONS AND USAGE Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.

The physician should periodically reassess the usefulness of the drug for the individual patient.

⏱️ Dosage and Administration 167 words

DOSAGE AND ADMINISTRATION Lorazepam Tablets, USP are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.

The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dose may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d. For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.

For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated. The dosage of lorazepam tablets should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.

Contraindications 22 words

CONTRAINDICATIONS Lorazepam is contraindicated in patients with • hypersensitivity to benzodiazepines or to any components of the formulation. • acute narrow-angle glaucoma.

⚠️ Warnings ~2 min read

WARNINGS Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis. Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants may lead to potentially fatal respiratory depression.

(See PRECAUTIONS , Clinically Significant Drug Interactions ) Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. As with all patients on CNS-depressant drugs, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other CNS depressants will be diminished. Physical and Psychological Dependence The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.

The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when lorazepam is used at the appropriate dose for short-term treatment. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving lorazepam or other psychotropic agents.

In general, benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks). Extension of the treatment period should not take place without reevaluation of the need for continued therapy.

Continuous long-term use of the product is not recommended. Withdrawal symptoms (e.g. rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.

Abrupt termination of treatment may be accompanied by withdrawal symptoms. Symptoms reported following discontinuation of benzodiazepines include headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia.

Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. There is evidence that tolerance develops to the sedative effects of benzodiazepines. Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

🤒 Adverse Reactions 204 words

ADVERSE REACTIONS Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses. In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria, slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactic/oid reactions; dermatological symptoms, allergic skin reactions, alopecia; SIADH, hyponatremia, thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam.

🆘 Overdosage ~1 min read

OVERDOSAGE In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. Therefore, in the management of overdosage, it should be borne in mind that multiple agents may have been taken. Symptoms Overdosage of benzodiazepines is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma.

In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death. Management General supportive and symptomatic measures are recommended; vital signs must be monitored and the patient closely observed.

When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit drug absorption.

Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. 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.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Studies in healthy volunteers show that in single high doses Lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Lorazepam is readily absorbed with an absolute bioavailability of 90 percent. Peak concentrations in plasma occur approximately 2 hours following administration.

The peak plasma level of lorazepam from a 2 mg dose is approximately 20 ng/mL. The mean half-life of unconjugated lorazepam in human plasma is about 12 hours and for its major metabolite, lorazepam glucuronide, about 18 hours. At clinically relevant concentrations, lorazepam is approximately 85% bound to plasma proteins.

Lorazepam is rapidly conjugated at its 3-hydroxy group into lorazepam glucuronide which is then excreted in the urine. Lorazepam glucuronide has no demonstrable CNS activity in animals. The plasma levels of lorazepam are proportional to the dose given.

There is no evidence of accumulation of lorazepam on administration up to six months. Studies comparing young and elderly subjects have shown that advancing age does not have a significant effect on the pharmacokinetics of lorazepam. However, in one study involving single intravenous doses of 1.5 to 3 mg of Lorazepam, mean total body clearance of lorazepam decreased by 20% in 15 elderly subjects of 60 to 84 years of age compared to that in 15 younger subjects 19 to 38 years of age.

📦 How Supplied / Storage and Handling 197 words

HOW SUPPLIED Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg white, round, flat face, beveled edge tablets, debossed “EP 904” on one side and plain on the other side. They are available as follows: Bottles of 100 Tablets NDC# 0904-6007-60 Bottles of 500 Tablets NDC# 0904-6007-40 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6007-61 1 mg white, round, flat face, beveled edge tablets, debossed “EP 905” and scored on one side and "1" on the other side. They are available as follows: Bottles of 100 Tablets NDC# 0904-6008-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6008-61 2 mg white, round, flat face, beveled edge tablets, debossed “EP 906” and scored on one side and "2" on the other side.

They are available as follows: Bottles of 100 Tablets NDC# 0904-6009-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6009-61 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. BOTTLES: Keep tightly closed Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.

📋 Description 57 words

DESCRIPTION Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o -chlorophenyl)-1,3-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate. Lorazepam structure

💬 Medication Guide ~3 min read

Medication Guide Lorazepam Tablets, USP CIV (lor az' e pam) What is the most important information I should know about lorazepam tablets? • Lorazepam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death . • Lorazepam tablets can make you sleepy or dizzy, and can slow your thinking and motor skills. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how lorazepam tablets affect you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking lorazepam tablets without first talking to your healthcare provider.

When taken with alcohol or drugs that cause sleepiness or dizziness, lorazepam tablets may make your sleepiness or dizziness much worse. • Do not take more lorazepam tablets than prescribed. What are lorazepam tablets? • Lorazepam tablets are a prescription medicine used: o to treat anxiety disorders o for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression • Lorazepam tablets are a federal controlled substance (C-IV) because it can be abused or lead to dependence.

Keep lorazepam tablets in a safe place to prevent misuse or abuse. Selling or giving away lorazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if lorazepam tablets are safe and effective in children less than 12 years of age. • It is not known if lorazepam tablets are safe and effective for use for longer than 4 months.

Do not take lorazepam tablets if you: • are allergic to lorazepam, other benzodiazepines, or any of the ingredients in lorazepam tablets. See the end of this Medication Guide for a complete list of ingredients in lorazepam tablets. Before you take lorazepam tablets, tell your healthcare provider about all of your medical conditions, including if you: • have or have had depression, mood problems, or suicidal thoughts or behavior • have a history of drug or alcohol abuse or addiction • have lung disease or breathing problems (such as COPD, sleep apnea syndrome) • have liver or kidney problems • have or have had seizures • are pregnant or plan to become pregnant.

Lorazepam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take lorazepam tablets while you are pregnant. • are breastfeeding or plan to breastfeed. Lorazepam passes into your breast milk and may harm your baby.

Talk to your healthcare provider about the best way to feed your baby if you take lorazepam tablets. You should not breastfeed while taking lorazepam tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking lorazepam tablets with certain other medicines can cause side effects or affect how well lorazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. How should I take lorazepam tablets? • Take lorazepam tablets exactly as your healthcare provider tells you to take it.

Your healthcare provider will tell you how many lorazepam tablets to take and when to take it. • If you take too many lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid while taking lorazepam tablets? • Lorazepam tablets can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how lorazepam tablets affect you. • You should not drink alcohol while taking lorazepam tablets.

Drinking alcohol can increase your chances of having serious side effects. What are the possible side effects of lorazepam tablets? Lorazepam tablets may cause serio…

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.