HomeNDC LookupIngredientsLorazepam › 71610-0122-45
Lorazepam 1 mg Tablet, 45-count — NDC 71610-0122-45 package photo

Lorazepam 1 mg Tablet, 45-count

by Aphena Pharma Solutions - Tennessee, LLC · 45 TABLET in 1 BOTTLE (71610-122-45)
NDC 71610-0122-45
🏷️ FDA NDC (as labeled) 71610-122-45 billing pads the product segment with a zero
This package
Contains45-count Pack sizes12 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) 71610-122-45
Product NDC 71610-122
11-digit billing NDC 71610012245
NCPDP billing unit EA — each (per item)
RxCUI 197901
UNII O26FZP769L
Application # ANDA078203
SPL Set ID 8df3eed3-c936-4772-ab08-574c54dd8bf5
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 57100060000310
GPI class LORazepam
GCN Seq No 003758
GCN 14161
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 1 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 71610-122-45 — 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 → 71610-0122-45. 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 1 MG TABLET Ingredient Lorazepam
📗 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;905;1
Size7 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 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 1 mg 00093-3426-01 Teva 100 tablets $0.036 AB Availability likely
Lorazepam 1 mg 00904-6008-60 Major 100 tablets $0.036 AB Discontinued
Lorazepam 1 mg 13107-0084-01 Aurolife 100 tablets $0.036 AB Availability likely
Lorazepam 1 mg 60687-0831-01 American 100 tablets $0.036 AB Availability likely
Lorazepam 1 mg 63304-0773-01 SUN 100 tablets $0.036 AB Availability likely
Lorazepam 1 mg 64980-0628-01 Rising 100 tablets $0.036 AB Availability likely
Lorazepam 1 mg 69315-0905-01 Leading 100 tablets $0.036 AB Availability likely
Ativan 1 mg 00187-0064-01 Bausch 100 tablets $44.095 AB FDA listed
Lorazepam 1 mg 50090-5508-00 A-S 30 tablets AB FDA listed
Lorazepam 1 mg 50090-5509-00 A-S 10 tablets AB FDA listed
Lorazepam 1 mg 50090-5562-00 A-S 30 tablets AB FDA listed
Lorazepam 1 mg 50090-5563-00 A-S 10 tablets AB FDA listed
Lorazepam 1 mg 51407-0997-01 Golden 100 tablets AB FDA listed
Lorazepam 1 mg 54348-0049-01 PharmPak, 1 tablet AB FDA listed
Lorazepam 1 mg 58118-1095-08 Clinical 30 tablets AB FDA listed
Lorazepam 1 mg 62135-0862-01 Chartwell 100 tablets FDA listed
Lorazepam 1 mg 62559-0196-01 ANI 100 tablets AB FDA listed
Lorazepam 1 mg 67046-0230-03 Coupler 30 tablets AB FDA listed
Lorazepam 1 mg 67296-2238-02 Redpharm 5 tablets AB FDA listed
Lorazepam 1 mg 68071-3227-01 NuCare 10 tablets AB FDA listed
Lorazepam 1 mg 68071-3242-03 NuCare 3 tablets AB FDA listed
Lorazepam 1 mg 68071-4918-03 NuCare 30 tablets AB FDA listed
Lorazepam 1 mg 68071-5022-05 NuCare 15 tablets AB FDA listed
Lorazepam 1 mg 68071-5250-02 NuCare 20 tablets AB FDA listed
Lorazepam 1 mg 68788-7428-01 Preferred 100 tablets AB FDA listed
Lorazepam 1 mg 70518-0275-00 REMEDYREPACK 30 tablets AB FDA listed
Lorazepam 1 mg 70518-0486-00 REMEDYREPACK 30 tablets AB FDA listed
Lorazepam 1 mg 70518-2186-02 REMEDYREPACK 30 tablets AB Discontinued
Lorazepam 1 mg 70518-2442-00 REMEDYREPACK 30 tablets AB Discontinued
Lorazepam 1 mg 70518-3423-00 REMEDYREPACK 30 tablets AB Discontinued
Lorazepam 1 mg 70518-3870-00 REMEDYREPACK 30 tablets AB Discontinued
Lorazepam 1 mg 70518-4276-00 REMEDYREPACK 100 tablets AB FDA listed
Lorazepam 1 mg 71205-0235-02 Proficient 2 tablets AB FDA listed
Lorazepam 1 mg 71335-1467-00 Bryant 10 tablets AB Discontinued
Lorazepam 1 mg 71335-1694-00 Bryant 10 tablets AB FDA listed
Lorazepam 1 mgthis 71610-0122-45 Aphena 45 tablets AB FDA listed
Lorazepam 1 mg 71610-0229-15 Aphena 15 tablets AB FDA listed
Lorazepam 1 mg 71610-0255-30 Aphena 30 tablets AB FDA listed
Lorazepam 1 mg 71610-0674-15 Aphena 15 tablets AB FDA listed
Lorazepam 1 mg 71610-0828-10 Aphena 10 tablets AB FDA listed
Lorazepam 1 mg 72789-0226-04 PD-Rx 4 tablets AB FDA listed
Lorazepam 1 mg 72789-0356-30 PD-Rx 30 tablets AB FDA listed
Lorazepam 1 mg 76420-0873-00 Asclemed 1000 tablets AB FDA listed
Lorazepam 1 mg 80425-0465-01 Advanced 30 tablets AB FDA listed
Lorazepam 1 mg 60760-0948-02 St. 2 tablets AB FDA listed
Lorazepam 1 mg 68788-4180-01 Preferred 100 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
71610-0122-10 10 TABLET in 1 BOTTLE (71610-122-10) 2018-08-15 Active
71610-0122-15 15 TABLET in 1 BOTTLE (71610-122-15) 2018-08-15 Active
71610-0122-70 120 TABLET in 1 BOTTLE (71610-122-70) 2018-08-15 Active
71610-0122-20 20 TABLET in 1 BOTTLE (71610-122-20) 2018-10-03 Active
71610-0122-28 28 TABLET in 1 BOTTLE (71610-122-28) 2023-12-21 Active
71610-0122-30 30 TABLET in 1 BOTTLE (71610-122-30) 2018-10-03 Active
71610-0122-45 You're viewing this 45 TABLET in 1 BOTTLE (71610-122-45) 2018-10-03 Active
71610-0122-53 60 TABLET in 1 BOTTLE (71610-122-53) 2018-10-03 Active
71610-0122-55 75 TABLET in 1 BOTTLE (71610-122-55) 2019-11-26 Active
71610-0122-60 90 TABLET in 1 BOTTLE (71610-122-60) 2018-10-03 Active
71610-0122-75 150 TABLET in 1 BOTTLE (71610-122-75) 2019-01-07 Active
71610-0122-80 180 TABLET in 1 BOTTLE (71610-122-80) 2018-10-03 Active

You're viewing one of 12 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0122-45?
NDC 71610-0122-45 is a 45-count package — 45 tablet in 1 bottle.
What is the difference between NDC 71610-0122-45 and NDC 71610-0122-10?
Both are Lorazepam 1 mg Tablet — the drug itself is identical. NDC 71610-0122-45 is the 45-count package, while NDC 71610-0122-10 is the 10 tablets package.
What NDC number is used to bill for this package of Lorazepam 1 mg Tablet?
Bill NDC 71610-0122-45 — the 11-digit billing format is 71610012245. 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 71610-122-45, 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: 71610-0122-45, written without dashes as 71610012245. 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 71610-0122-45, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0122) 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 11 other package presentations of this same product, including 10 tablets (71610-0122-10), 15 tablets (71610-0122-15), 20 tablets (71610-0122-20). 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.
🚨 Boxed Warning 71 words

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death ( see WARNINGS; PRECAUTIONS, Clinically Significant Drug Interactions ). • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.

🎯 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 170 words

DOSAGE AND ADMINISTRATION Lorazepam is 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 dosage may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given two times a day or three times a day. 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 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 Concomitant use of benzodiazepines, including Lorazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe Lorazepam 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. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Lorazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Lorazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Lorazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see PRECAUTIONS , Clinically Significant Drug Interactions ). 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 comm…

🤒 Adverse Reactions ~1 min read

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. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS.

YOU MAY REPORT SIDE EFFECTS TO THE FDA AT Phone # 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

🆘 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 CNS 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 CONTRAINDICATION, 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%. 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 6 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 injection, 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 186 words

HOW SUPPLIED 0.5 mg White color, round, flat face beveled edge compressed tablets, debossed "EP" and "904" on one side, and plain on the other side. Bottles of 100 Tablets NDC# 0904-6007-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6007-61 1 mg White color, round, bisected flat face beveled edge compressed tablets, debossed "EP" above bisect and "905" below bisect on one side, and "1" on the other side. 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 color, round, bisected flat face beveled edge compressed tablets, debossed "EP" above bisect and "906" below bisect on one side, and "2" on the other side.

Bottles of 100 Tablets NDC# 0904-6009-60 Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6009-61 BOTTLES: Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. Keep this and all Medications out of the reach of children. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Excursions permitted to 59˚ to 86˚F (15˚ to 30˚C).

📋 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, magnesium stearate, microcrystalline cellulose and polacrilin potassium. Lorazepam structure

💬 Medication Guide ~3 min read

MEDICATION GUIDE Lorazepam Tablets, CIV (lor az' e pam) What is the most important information I should know about Lorazepam? • Lorazepam is 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 can make you sleepy or dizzy, and can slow your thinking and motor skills. • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Lorazepam affects you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Lorazepam without first talking to your healthcare provider.

When taken with alcohol or drugs that cause sleepiness or dizziness, Lorazepam may make your sleepiness or dizziness much worse. • Do not take more Lorazepam than prescribed. What is Lorazepam? • Lorazepam is a prescription medicine used: • to treat anxiety disorders • for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression • Lorazepam is a federal controlled substance (CIV) because it can be abused or lead to dependence. Keep Lorazepam in a safe place to prevent misuse and abuse.

Selling or giving away Lorazepam 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 is safe and effective in children less than 12 years of age. • It is not known if Lorazepam is safe and effective for use for longer than 4 months. Do not take Lorazepam if you: • are allergic to lorazepam, other benzodiazepines, or any of the ingredients in Lorazepam .

See the end of this Medication Guide for a complete list of ingredients in Lorazepam Before you take Lorazepam , 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 may harm your unborn baby.

You and your healthcare provider should decide if you should take Lorazepam 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 .

You should not breastfeed while taking Lorazepam Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Lorazepam with certain other medicines can cause side effects or affect how well Lorazepam or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take Lorazepam? • Take Lorazepam exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Lorazepam to take and when to take it. • If you take too much Lorazepam , call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid while taking Lorazepam? • Lorazepam can cause you to be drowsy.

Do not drive a car or operate heavy machinery until you know how Lorazepam affects you. • You should not drink alcohol while taking Lorazepam . Drinking alcohol can increase your chances of having serious side effects. What are the possible side effects of Lorazepam?

Lorazepam may cause serious side effects, including: • See “What is the most important information I should know about Lorazepam?” • Depression . Pre-existing depression may emerge or worsen during use of benzodiazepines including Lorazepam . • Abuse and dependence. Taking Lorazepam can cause physical…

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.