LOREEV XR Dosage & Rx Info | Uses, Side Effects

Loreev Xr Generic Name & Formulations

Legal Class

CIV

General Description

Lorazepam 1mg+, 1.5mg, 2mg, 3mg; ext-rel caps; +contains tartrazine.

Pharmacological Class

Benzodiazepine.

How Supplied

Caps—30, 100

Manufacturer

Almatica Pharma

Generic Availability

Mechanism of Action

Lorazepam exerts its effect for the treatment of anxiety disorders through binding to the benzodiazepine site of the gamma-aminobutyric acid-A (GABA_A) receptors in the brain and enhances GABA-mediated synaptic inhibition.

Loreev Xr Indications

Indications

Anxiety disorders in adults who are receiving stable, evenly divided, 3 times daily dosing with lorazepam tabs.

Loreev Xr Dosage and Administration

Adult

Swallow whole or open cap and sprinkle contents onto applesauce (1 tbsp). Administer the 1^st dose the day after the final dose of lorazepam tabs. Give once daily in the morning. Recommended once daily dose = the total daily dose of lorazepam tabs. For inadequate clinical response, concomitant UGT inhibitors: discontinue Loreev XR, switch to lorazepam tabs, and then adjust dosage.

Children

Not established.

Loreev Xr Contraindications

Contraindications

Acute narrow-angle glaucoma.

Loreev Xr Boxed Warnings

Boxed Warning

Risk from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Loreev Xr Warnings/Precautions

Warnings/Precautions

Increased risk of drug-related mortality from concomitant use with opioids. Therapy for >4 months. Discontinue if paradoxical reactions occur. Primary depressive disorder or psychosis: not recommended. Suicidal ideation (monitor). Compromised respiratory function (eg, respiratory depression, apnea); monitor closely. Reevaluate periodically. Monitor CBCs, LFTs during long-term therapy. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Change dose gradually. Write ℞ for smallest practical amount. Drug or alcohol abuse. Severe hepatic impairment and/or encephalopathy. Elderly. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: not recommended.

Loreev Xr Pharmacokinetics

Absorption

Following a single 3 mg dose of Loreev XR under fasted conditions, the median time to attain C_max (T_max) is 14 hours, with a range of 7–24 hours.

Distribution

The mean apparent volume of distribution is ~117 L.

Lorazepam is ~85% plasma protein bound.

Metabolism

Hepatic.

Elimination

Renal. Half-life: 20.2 ± 7.2 hours.

Loreev Xr Interactions

Interactions

Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Potentiates CNS depression with alcohol (avoid), clozapine, other CNS depressants; caution. May be potentiated by UGT inhibitors (eg, valproate, probenecid); if unavoidable, reduce dose (see Adult).

Loreev Xr Adverse Reactions

Adverse Reactions

Sedation, dizziness, weakness, unsteadiness; withdrawal reactions, CNS depression.

Loreev Xr Clinical Trials

See Literature

Loreev Xr Note

Not Applicable

Loreev Xr Patient Counseling