For us healthcare professionals onlyOnce-Daily Loreev XR® (lorazepam) Extended-Release Capsules
Actor portrayal.

Help patients gain control of their day.
Treat their anxiety with LOREEV XR®, a once-daily extended-release capsule.1

Convenient once-daily dosing

Administer once daily in the morning, with or without food1

Sprinkle dose option1

  • Patients have the option to open the capsule and sprinkle the entire contents over a tablespoon of applesauce, followed by drinking water
  • Do not crush or chew LOREEV XR


To switch patients from lorazepam IR to LOREEV XR:

  • Discontinue lorazepam immediate-release (IR) tablets and administer the first dose of LOREEV XR the next morning1
  • Once-daily dosage of LOREEV XR is equal to the total daily dose of lorazepam IR tablets1

Formulated to deliver a smooth PK profile throughout the day for patients124

Steady-state, 24-hour PK profile2

  • Median Tmax of 9 hours at steady state2
  • Minimal fluctuations throughout the day2
  • Bioequivalent to lorazepam IR tablets dosed 3 times daily at steady state4

LOREEV XR 3 mg once daily vs lorazepam IR tablets 1 mg q8h14

Chart that shows the benefits of the LoreevXR formulation

Study design (N=48):

Randomized, open-label, 2-way crossover, 2-period, 2-sequence, 2-treatment, relative bioavailability study at steady state, with a 10-day washout period. PK profile draws on day 8. Steady state was achieved by day 5.14

Diagram showing capsule containing beads
Visual representation. Not actual pill or bead size.

Two-bead extended-release delivery system

LOREEV XR combines 2 types of extended-release beads to provide a smooth 24-hour profile2

  • Extended-release beads begin to slowly release after ingestion; delayed extended-release beads begin to release several hours after ingestion2
  • The combination of different bead-release profiles delivers:
    • Slow plasma level rise to Cmax (Tmax 9 hours)2
    • Minimal plasma level fluctuation over 24 hours2

Metabolism

Approximately 70% to 80% of all drugs in clinical use are metabolized through the cytochrome P450 (CYP450) pathway.5 Lorazepam is not.13

Why does this matter?

Lorazepam is metabolized differently—via glucuronidation13

This difference is important because concomitant administration of multiple drugs that share the CYP450 metabolic pathway has the potential for drug-to-drug interactions that may lead to6:

  • Reduced efficacy
  • Drug toxicity

Fewer drug-to-drug interactions may be associated with glucuronidation metabolism vs the CYP450 system.78

Lorazepam is metabolized differently from these common benzodiazepines, SSRIs, and SNRIs.

Metabolic Pathway
MedicationCYP450 2C19CYP450 2D6CYP450 3A4 inhibitors and inducersGlucuronidation via UGTs
Benzodiazepines
Lorazepam1
Alprazolam9
Clonazepam10
Diazepam11
SSRIs and SNRIs
Citalopram12
Duloxetine13Metabolized via multiple paths
Escitalopram14
Fluoxetine15
Fluvoxamine16
Levomilnacipran17
Paroxetine18
Sertraline19
Vilazodone20
Vortioxetine21
Venlafaxine22
SSRIs=selective serotonin reuptake inhibitors; SNRIs=serotonin-norepinephrine reuptake inhibitors; UGTs=UDP-glucuronosyltransferases.

Help your patients manage their medication costs

Copay Card
Not actual copay card.

With the LOREEV Patient Savings Program, eligible insured patients pay as little as $20/month for LOREEV XR*

Download information about the Patient Savings Program

* Applies to commercially insured patients. Individual costs may vary. Program eligibility and restrictions apply.

Important Safety Information

Indication for Use

LOREEV XR is indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets.

Contraindications

LOREEV XR is contraindicated in patients with:

  • Hypersensitivity to benzodiazepines or any ingredients in LOREEV XR
  • Acute narrow-angle glaucoma

Warnings and Precautions

Central Nervous System (CNS) Depression

  • LOREEV XR may produce CNS depression. Caution against engaging in hazardous occupations or activities requiring complete mental alertness.
  • Use alone and with other CNS depressants may lead to potentially fatal respiratory depression. Alcohol should be avoided, and other CNS depressants used with caution.

Patients with Depression or Psychosis

  • LOREEV XR is not recommended in patients with a primary depressive disorder or psychosis. Preexisting depression may emerge or worsen.
  • A possibility for suicide should be kept in mind in patients with depression. Benzodiazepines should not be used without adequate antidepressant therapy.

Risk of Paradoxical Reactions

  • Paradoxical reactions have occasionally been reported during benzodiazepine use and are more likely to occur in the elderly. If this occurs, discontinue LOREEV XR.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine)

  • LOREEV XR 1 mg capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions in certain individuals and is seen frequently in patients who also have aspirin hypersensitivity.

Neonatal Sedation and Withdrawal Syndrome

  • LOREEV XR use during later stages of pregnancy can result in sedation and/or withdrawal symptoms in the neonate. Monitor neonates during pregnancy and labor for signs of sedation and withdrawal.

Risk in Patients With Impaired Respiratory Function

  • Closely monitor patients taking LOREEV XR for impaired respiratory function, and consider discontinuing it if signs and symptoms of respiratory depression or apnea occur.

Laboratory Tests

  • Leukopenia and elevations of lactase dehydrogenase (LDH) have developed in patients receiving lorazepam tablets. Periodic blood counts and liver function tests are recommended during long-term therapy.

Adverse reactions

Most frequent adverse reactions in clinical trials were sedation (15.9%), dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%).

Drug interactions

Avoid initiation of UDP-glucuronosyltransferase (UGT) inhibitors. Dose reduction requires switching to lorazepam tablets for dose adjustment.

Use in specific populations

Because of the potential for serious adverse reactions, breastfeeding is not recommended during treatment with LOREEV XR.

For additional safety information about LOREEV XR, see the LOREEV XR Full Prescribing Information including Boxed Warning and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979, or the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Request a rep
Request a rep

References:

  1. LOREEV XR. Prescribing information. Almatica Pharma LLC; 2023.
  2. Saltel DA, Vachon M. Edgemont Pharmaceuticals LLC. Sustained release formulations of lorazepam. US patent 8,999,393 B1. April 7, 2015.
  3. Altamura AC, Moliterno D, Paletta S, Maffini M, Mauri MC, Bareggi S. Understanding the pharmacokinetics of anxiolytic drugs. Expert Opin Drug Metab Toxicol. 2013;9(4):423-440.
  4. Data on file. Almatica Pharma LLC; 2020.
  5. Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther. 2013;138(1):103-141.
  6. Ogu CC, Maxa JL. Drug interactions due to cytochrome P450. Proc (Bayl Univ Med Cent). 2000;13(4):421-423.
  7. Deodhar M, Al Rihani SB, Arwood MJ, et al. Mechanisms of CYP450 inhibition: understanding drug-drug interactions due to mechanism-based inhibition in clinical practice.Pharmaceutics. 2020;12(9):846.
  8. Ramadan MI, Werder SF, Preskorn SH. Protect against drug-drug interactions with anxiolytics.Curr Psychiatry. 2006;5(5):16-28.
  9. Xanax. Prescribing information. Pfizer Inc; 2021.
  10. Klonopin. Prescribing information. Genentech, Inc; 2021.
  11. Valium. Prescribing information. Hoffmann-La Roche, Inc; 2021.
  12. Citalopram. Prescribing information. Almatica Pharma LLC; 2023.
  13. Cymbalta. Prescribing information. Lilly USA, LLC; 2023.
  14. Lexapro. Prescribing information. Allergan USA, Inc; 2016.
  15. Prozac. Prescribing information. Lilly USA, LLC, 2016.
  16. Fluvoxamine maleate. Prescribing information. ANI Pharmaceuticals, Inc; 2012.
  17. Fetzima. Prescribing information. AbbVie Inc; 2023.
  18. Paxil CR. Prescribing information. Apotex Inc; 2024.
  19. Zoloft. Prescribing information. Viatris Specialty LLC; 2023.
  20. Viibryd. Prescribing information. AbbVie Inc; 2023.
  21. Trintellix. Prescribing information. Takeda Pharmaceuticals America, Inc; 2023.
  22. Venlafaxine. Prescribing information. Almatica Pharma LLC; 2023.