Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lorazepam Oral Concentrate, USP The 2 mg per mL oral concentrate is supplied as a clear colorless to light yellow solution. NDC 62135-549-43: Bottle of 30 mL PROTECT FROM LIGHT Store at cold temperature. Refrigerate at 2° to 8°C (36° to 46°F) [See USP Controlled Cold Temperature]. Dispense from this bottle. Discard opened bottle after 90 days . Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71400 Revised 04/2023-01 Print Medication Guide at www.chartwellpharma.com/medguides; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lorazepam Oral Concentrate, USP (CIV) 2 mg/mL - NDC 62135-549-43 - 30 mL - Bottle Label image description
- HOW SUPPLIED Lorazepam Oral Concentrate, USP The 2 mg per mL oral concentrate is supplied as a clear colorless to light yellow solution. NDC 62135-549-43: Bottle of 30 mL PROTECT FROM LIGHT Store at cold temperature. Refrigerate at 2° to 8°C (36° to 46°F) [See USP Controlled Cold Temperature]. Dispense from this bottle. Discard opened bottle after 90 days . Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71400 Revised 04/2023-01 Print Medication Guide at www.chartwellpharma.com/medguides
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lorazepam Oral Concentrate, USP (CIV) 2 mg/mL - NDC 62135-549-43 - 30 mL - Bottle Label image description
Overview
Lorazepam, an antianxiety agent, has the chemical formula, 2 H -1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-: C 15 H 10 Cl 2 N 2 O 2 MW: 321.16 Lorazepam, USP is a white or a practically white powder almost insoluble in water. Each mL of Lorazepam for oral administration contains 2 mg of lorazepam. The inactive ingredients present are polyethylene glycol and propylene glycol. image description
Indications & Usage
Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Dosage & Administration
Not available
Warnings & Precautions
WARNINGS
Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs 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 (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage ( DOSAGE AND ADMINISTRATION and WARNINGS ).
Contraindications
Lorazepam is contraindicated in patients with: • hypersensitivity to benzodiazepines or to any components of the formulation. • acute narrow-angle glaucoma.
Adverse Reactions
Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses. In a sample of about 3,500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age. Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; syndrome of inappropriate antidiuretic hormone (SIADH), hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations. 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 may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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