LOREEV XR™ (lorazepam) Important Safety Information

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant use 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.
Use of LOREEV XR exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
Abrupt discontinuation or rapid dosage reduction of LOREEV XR after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce this risk, use a gradual taper to discontinue or reduce the dosage.

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, please see the Full Prescribing Information 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 call 1‑800‑FDA‑1088.

Reference:

LOREEV XR. Prescribing information. Almatica Pharma LLC; 2021.

LOREEV XR and the LOREEV XR logo are trademarks or registered trademarks of Almatica Pharma LLC.
Almatica and the Almatica logo are trademarks or registered trademarks of Alvogen TM S.a.r.l.