Prescribing InformationMedication Guide
For us healthcare professionals onlyOnce-Daily Loreev XR® (lorazepam) Extended-Release Capsules

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Patient Profiles

Angela
(she/her)
Angela
Actor portrayals.
Age
40
Marital Status
Divorced, mother of 2
Profession
Teacher
Diagnosis
Generalized anxiety disorder (GAD) @ 38 years old
GAD Treatment
Lorazepam 0.5 mg TID
Other Treatments
Cognitive behavioral therapy
Comorbidities
None
Insurance
PPO provided by employer

Angela's challenge:

She is worried about missing a dose during the day yet does not want to carry medication with her into her classroom.

In recent office visits:

With the newfound responsibilities of single parenthood since her divorce, Angela reported being very worried about how her anxiety may affect her.

Angela's doctor prescribed lorazepam 0.5 mg TID. This is helping, but she finds it challenging to take the midday dose. She would like to know if a once-daily lorazepam option is available.

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.

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References:

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