Lorazepam 2 mg/mL
Lorazepam · SOLUTION, CONCENTRATE · Hikma Pharmaceuticals USA Inc.
Lorazepam is a benzodiazepine medication used to treat anxiety, insomnia, and seizures. It comes as an oral liquid concentrate that you swallow, and it requires a prescription from your doctor.
Key Facts
- Brand Name
- Lorazepam
- Generic Name
- Lorazepam
- NDC Code (Product)
0054-3532- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 2 mg/mL
- Dosage Form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA072755
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 06/28/1991
Recall History
Family Pharmacy of Statesville
Lack of Assurance of Sterility
Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Safecor Health, LLC
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Leading Pharma, LLC
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Lorazepam tablets are 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 tablets 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
DOSAGE AND ADMINISTRATION Lorazepam tablets are administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available. The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given two times a day or three times a day. For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime. For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated. The dosage of lorazepam tablets should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses. Discontinuation or Dosage Reduction of Lorazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage. If a patient d…
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including lorazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe lorazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of lorazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking lorazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when lorazepam is used …
Contraindications
CONTRAINDICATIONS Lorazepam is contraindicated in patients with: • hypersensitivity to benzodiazepines or to any components of the formulation • acute narrow-angle glaucoma.
Drug Interactions
Drug Interactions 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 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. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics. Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest. Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be r…
Adverse Reactions
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 3500 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;…
Frequently Asked Questions
What is Lorazepam used for?
Lorazepam is a benzodiazepine medication used to treat anxiety, insomnia, and seizures. It comes as an oral liquid concentrate that you swallow, and it requires a prescription from your doctor.
Is Lorazepam a controlled substance?
Yes, Lorazepam is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Lorazepam?
The generic name for Lorazepam is Lorazepam. There are 4 other brand versions of Lorazepam.
What is the NDC code for Lorazepam 2 mg/mL?
The NDC (National Drug Code) for Lorazepam 2 mg/mL is 0054-3532, listed by Hikma Pharmaceuticals USA Inc..