LOREEV XR 3 mg/1
lorazepam · CAPSULE, EXTENDED RELEASE · Almatica Pharma LLC
LOREEV XR is a capsule, extended release containing lorazepam at 3 mg/1, taken oral. Manufactured by Almatica Pharma LLC.
Key Facts
- Brand Name
- LOREEV XR
- Generic Name
- lorazepam
- NDC Code (Product)
52427-667- Manufacturer
- Almatica Pharma LLC
- Strength
- 3 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA214826
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 08/31/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. LOREEV XR is a benzodiazepine indicated for the treatment of anxiety disorders in adults who are receiving stable, evenly divided, three times daily dosing with lorazepam tablets ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage of LOREEV XR is equal to the total daily dose of lorazepam tablets (at the previous three times daily dosage) ( 2.1 ) Administer LOREEV XR orally once daily in the morning ( 2.2 ) Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce. Do not crush or chew ( 2.2 ) For dosage adjustments, discontinue LOREEV XR and switch to lorazepam tablets to adjust dosage ( 2.3 ) 2.1 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 bee…
Contraindications
4 CONTRAINDICATIONS LOREEV XR is contraindicated in patients with: hypersensitivity to benzodiazepines or to any of the ingredients in LOREEV XR [see Warnings and Precautions ( 5.7 )] . acute narrow-angle glaucoma Hypersensitivity to benzodiazepines or any ingredients in LOREEV XR ( 4 ) Acute narrow-angle glaucoma ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1 presents clinically significant interactions with LOREEV XR. Use with Opioids: Increase the risk of respiratory depression ( 7 ) CNS depressants: Additive CNS depressant effects (7) Alcohol: Avoid use. Increases the release rate of LOREEV XR (7) UGT Inhibitors: Avoid initiation of UGT inhibitors. Dose reduction requires switching to lorazepam tablets for dose adjustment (7) Table 1: Clinically Significant Drug Interactions with LOREEV XR. Opioids Clinical Impact The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at gamma-aminobutyric acid (GABA A ) sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists [see Warnings and Precautions ( 5.1 )] . Intervention Limit dosage and duration of concomitant use of LOREEV XR and opioids, and monitor patients closely for respiratory depression and sedation. Alcohol Clinical Impact Based on an in vitro study, alcohol incr…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Central Nervous System (CNS) Depression [see Warnings and Precautions ( 5.4 )] Patients with Depression or Psychosis [see Warnings and Precautions ( 5.5 )] Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) [see Warnings and Precautions ( 5.7 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.8 )] Risk in Patients with Impaired Respiratory Function [see Warnings and Precautions ( 5.9 )] The safety of LOREEV XR in adults is based on studies with lorazepam tablets. The following adverse reactions associated with the use of lorazepam tablets were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In a sample of approximately …
Frequently Asked Questions
What is LOREEV XR used for?
LOREEV XR contains lorazepam. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is LOREEV XR a controlled substance?
Yes, LOREEV XR is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for LOREEV XR?
The generic name for LOREEV XR is lorazepam. There are 11 other brand versions of lorazepam.
What is the NDC code for LOREEV XR 3 mg/1?
The NDC (National Drug Code) for LOREEV XR 3 mg/1 is 52427-667, listed by Almatica Pharma LLC.