Loreev XR Side Effects Center

Last updated on RxList: 11/4/2021
Loreev XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Loreev XR?

Loreev XR (lorazepam capsule, extended release) 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.

What Are Side Effects of Loreev XR?

Side effects of Loreev XR include:

The use of benzodiazepines, including Loreev XR, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. 

Abrupt discontinuation or rapid dosage reduction of Loreev XR after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures).

Dosage for Loreev XR

The recommended dosage of Loreev XR is equal to the total daily dose of lorazepam tablets (at the previous three times daily dosage). 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.

Loreev XR In Children

The safety and effectiveness of Loreev XR has not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Loreev XR?

Loreev XR may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Loreev XR During Pregnancy and Breastfeeding

 Tell your doctor if you are pregnant or plan to become pregnant before using Loreev XR; infants born to mothers using benzodiazepines during the later stages of pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Loreev XR during pregnancy. Loreev XR passes into breast milk. Because of the potential for serious adverse reactions, including sedation and withdrawal, breastfeeding is not recommended while using Loreev XR. 

Additional Information

Our Loreev XR (lorazepam capsule, extended release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Panic attacks are repeated attacks of fear that can last for several minutes. See Answer
Loreev XR Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
  • Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS]
  • Dependence and Withdrawal Reactions [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System (CNS) Depression [see WARNINGS AND PRECAUTIONS]
  • Patients with Depression or Psychosis [see WARNINGS AND PRECAUTIONS]
  • Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) [see WARNINGS AND PRECAUTIONS]
  • Risk in Patients with Impaired Respiratory Function [see WARNINGS AND PRECAUTIONS]

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 3,500 patients treated for anxiety, the most frequent adverse reactions to lorazepam tablets were sedation (15.9%), dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

The following reported adverse reactions are categorized by System Organ Class (SOC)

Blood and Lymphatic System Disorders: agranulocytosis, leukopenia, pancytopenia, thrombocytopenia

Endocrine Disorders: syndrome of inappropriate antidiuretic hormone (SIADH)

Eye Disorder: eye function/visual disturbance (including diplopia and blurred vision)

Gastrointestinal Disorder: constipation, gastrointestinal symptoms including nausea

General Disorders and Administration Site Conditions: asthenia, fatigue, hypothermia

Hepatobiliary Disorders: jaundice

Immune System Disorders: anaphylactoid reactions, hypersensitivity reactions

Investigations: increase in bilirubin, increase in liver transaminases (including elevated LDH), increase in alkaline phosphatase Metabolism and Nutrition Disorders: change in appetite, hyponatremia

Nervous System Disorders: ataxia, autonomic manifestations, coma, convulsions/seizures, drowsiness, dysarthria/slurred speech, extrapyramidal symptoms, headache, tremor, vertigo, memory impairment

Psychiatric Disorders: amnesia, change in libido, confusion, decreased orgasm, depression, disinhibition, disorientation, euphoria, suicidal ideation/attempt, unmasking of depression

Reproductive System and Breast Disorders: impotence

Respiratory Thoracic and Mediastinal Disorders: apnea, respiratory depression, worsening of obstructive pulmonary disease, worsening of sleep apnea

Skin and Subcutaneous Tissue Disorder: allergic skin reactions, alopecia, dermatological symptoms

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur.

Small decreases in blood pressure and hypotension have been reported with immediate-release lorazepam.

Many adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.

DRUG INTERACTIONS

Table 1 presents clinically significant interactions with LOREEV XR.

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 ) 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].
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 increases the release rate of LOREEV XR [see CLINICAL PHARMACOLOGY].
Intervention Avoid concomitant use of alcohol during treatment with LOREEV XR [see WARNINGS AND PRECAUTIONS].
CNS-Depressants
Clinical Impact Benzodiazepines, including LOREEV XR, increase CNS-depressant effects when administered with other CNS depressants. Concomitant use of clozapine and LOREEV XR may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.
Intervention InterventionAvoid co-administration of alcohol with LOREEV XR. Use caution if LOREEV XR is co-administered with other CNS-depressants [see WARNINGS AND PRECAUTIONS].
Inhibitors of UGT
Clinical Impact Concomitant use of LOREEV XR with UGT inhibitors may increase lorazepam exposure [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions.
Intervention Avoid initiating an UGT inhibitor during treatment with LOREEV XR. If an UGT inhibitor is initiated, discontinue LOREEV XR and switch to lorazepam tablets [see DOSAGE AND ADMINISTRATION].

Drug Abuse And Dependence

Controlled Substance

LOREEV XR contains lorazepam, a Schedule IV controlled substance.

Abuse

LOREEV XR is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see WARNINGS AND PRECAUTIONS].

The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

Dependence

Physical Dependence

LOREEV XR may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see WARNINGS AND PRECAUTIONS].

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue LOREEV XR or reduce the dosage [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Acute Withdrawal Signs and Symptoms

Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality.

Protracted Withdrawal Syndrome

Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential reemergence or continuation of symptoms for which the benzodiazepine was being used.

Tolerance

Tolerance to LOREEV XR may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of LOREEV XR may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Read the entire FDA prescribing information for Loreev XR (Lorazepam Extended-release Capsules)

SLIDESHOW

Anxiety Disorder Pictures: Symptoms, Panic Attacks, and More with Pictures See Slideshow

© Loreev XR Patient Information is supplied by Cerner Multum, Inc. and Loreev XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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