Lorazepam (oral)

Lorazepam (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Lorazepam (oral) is an antianxiety drug that is FDA approved for the treatment of anxiety disorders, status epilepticus, insomnia and as premedication for anesthetic procedure. Common adverse reactions include fatigue, drowsiness, amnesia, confusion, disorientation, depression, euphoria, ataxia, asthenia, tremor, and vertigo.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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

• Lorazepam is 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 b.i.d. or t.i.d.

• 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 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lorazepam (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lorazepam (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Lorazepam (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lorazepam (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lorazepam (oral) in pediatric patients.

Contraindications

There is limited information regarding Lorazepam (oral) Contraindications in the drug label.

Warnings

There is limited information regarding Lorazepam (oral) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Lorazepam (oral) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Lorazepam (oral) in the drug label.

Drug Interactions

• 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 reduced to approximately 50% when coadministered with valproate.

• Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.

• The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.

• Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lorazepam (oral) in women who are pregnant.
Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lorazepam (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lorazepam (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lorazepam (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Lorazepam (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Lorazepam (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Lorazepam (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lorazepam (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lorazepam (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lorazepam (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lorazepam (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lorazepam (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Lorazepam (oral) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Lorazepam (oral) in the drug label.

Overdosage

• In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. Therefore, in the management of overdosage, it should be borne in mind that multiple agents may have been taken.

Symptoms

• Overdosage of benzodiazepines is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death.

MANAGEMENT

• General supportive and symptomatic measures are recommended; vital signs must be monitored and the patient closely observed. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit drug absorption. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.

• The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

Pharmacology

There is limited information regarding Lorazepam (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Lorazepam (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Lorazepam (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Lorazepam (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Lorazepam (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Lorazepam (oral) in the drug label.

How Supplied

• Lorazepam Tablets USP are available in the following dosage strengths:

• 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000.

• 1 mg: white, scored, round flat faced beveled edge, debossed with 241 over 1 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000.

2 mg: white, scored, round flat faced beveled edge, debossed with 242 over 2 on one side and WATSON on the other side, supplied in bottles of 100, 500 and 1000.

Storage

• Store at 20°-25°C (68°-77°F).

• Dispense in a tight, light-resistant container as defined in the USP.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Lorazepam (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Lorazepam (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• LORAZEPAM®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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