Recommended Dosage

Initiate LOREEV XR in patients who are being treated with lorazepam tablets, administered three times daily in evenly divided doses (refer to the Prescribing Information of lorazepam tablets for the recommended dosage of lorazepam tablets).

Discontinue lorazepam tablets and administer the first dose of LOREEV XR in the morning the day after the final dose of lorazepam tablets.

The recommended once daily dosage of LOREEV XR is equal to the total daily dose of lorazepam tablets. For example, the recommended dosage for patients who have been receiving lorazepam tablets at a dosage of 1 mg three times daily is LOREEV XR 3 mg once daily in the morning.

The effectiveness of LOREEV XR use for more than 4 months has not been assessed in clinical studies. Healthcare providers should periodically re-evaluate longer term use of LOREEV XR.

Administration Information

Administer LOREEV XR orally once daily, in the morning, with or without food. Do not crush or chew LOREEV XR.

Swallow LOREEV XR capsules whole or open the capsule and sprinkle the entire contents over a tablespoon of applesauce, followed by drinking water. Consume all the sprinkled LOREEV XR in its entirety, (without chewing) within 2 hours; do not store for future use.

Dosage Increase for Inadequate Clinical Response

If the clinical response to LOREEV XR is inadequate and a dosage increase in needed, discontinue LOREEV XR and switch to lorazepam tablets to increase the dosage. If an adequate clinical response is achieved with a stable, evenly divided three times daily dosage of lorazepam tablets, resume LOREEV XR once daily dosing with the total daily dose of lorazepam tablets [see Dosage and Administration (2.1)].

Discontinuation or Dosage Reduction of LOREEV XR

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue LOREEV XR or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].

Concomitant Use with UDP-glucuronosyltransferase (UGT) Inhibitors

If an UGT inhibitor is initiated during treatment with LOREEV XR, discontinue LOREEV XR and switch to lorazepam tablets to reduce the dosage [see Dosage and Administration (2.4), Drug Interactions (7)].