Lorazepam Full Prescribing Information

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Brand Name: Ativan
Generic Name: Lorazepam

Lorazepam, Ativan is an anti-anxiety medication to relieve anxiety and anxiety associated with depressive symptoms. Usage, dosage, side effects of Lorazepam.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Ativan patient information (in plain English)

Description

Lorazepam (Ativan) is a benzodiazepine used to relieve anxiety.

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Pharmacology

Studies in healthy volunteers show that in single high doses Lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Peak concentrations in plasma occur approximately 2 hours following administration. The peak plasma level of lorazepam from a 2 mg dose is approximately 20 ng/ml.

Anterograde amnesia, decreased or lack of recall of events during period of drug action, has been reported after administration of lorazepam and appears to be dose-related.

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Indications and Usage

Ativan (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.

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Injectable lorazepam is useful as an initial anticonvulsant medication for the control of status epilepticus and fpr producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery

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Contraindications

Lorazepam is contraindicated in patients with known sensitivity to the benzodiazepines or with acute narrow-angle glaucoma or myasthenia gravis.

Lorazepam injectable is also contraindicated in patients with known hypersensitivity to polyethylene glycol, propylene glycol or benzyl alcohol.

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Warnings

Lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis. As with all patients on CNS-acting drugs, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other CNS depressants will be diminished.

Physical and Psychological Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of lorazepam. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving lorazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

As with any premedicant, extreme care must be used in administering lorazepam injection to elderly or very ill patients and to those with limited pulmonary reserve, because of the possibility that apnea and/or cardiac arrest may occur. Because of the lack of sufficient clinical experience lorazepam injection is not recommended for use in patients less than 18 years of age.

Since the liver is the most likely site of conjugation of lorazepam and since excretion of conjugated lorazepam (glucuronide) is a renal function, this drug is not recommended for use in patients with hepatic and/or renal failure. This does not preclude use of the drug in patients with mild-to-moderate hepatic or renal disease, the lowest effective dose should be considered since drug effect may be prolonged. Experience with other benzodiazepines and limited experience with parenteral lorazepam has demonstrated that tolerance to alcoholic beverages and other central- nervous-system depressants is diminished when used concomitantly.

As is true of similar CNS-acting drugs, patients receiving injectable lorazepam should not operate machinery or engage in hazardous occupations or drive a motor vehicle for a period of 34 to 48 hours. Impairment of performance may persist for greater intervals because of extremes of age, concomitant use of other drugs, stress of surgery, or the general condition of the patient.

Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged sedation with intravenous lorazepam. Ordinarily, an initial dose of 2 mg may be adequate unless a greater degree of lack of recall is desired.

As with all central-nervous system depressant drugs, care should be exercised in patients given injectable lorazepam that premature ambulation may result in injury from falling.

There is no added beneficial effect to the addition of scopolamine to injectable lorazepam, and their combined effect may result in an increased incidence of sedation, hallucination, and irrational behavior.

Usage in Pregnancy

LORAZEPAM MAY CAUSE FETAL DAMAGE WHEN ADMINISTERED TO PREGNANT WOMEN. An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. In humans, blood levels obtained from umbilical cord blood indicate placental transfer of lorazepam and lorazepam glucuronide.

Lorazepam injection should not be used during pregnancy. There is insufficient data regarding obstetrical safety of parenteral lorazepam, including use in cesarean section. Such use, therefore, is not recommended. It is not known whether oral lorazepam is excreted in human milk like the other benzodiazepine tranquilizers. As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.

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Precautions

In patients with depression accompanying anxiety, a possibility for suicide should be kept in mind.

For elderly or debilitated patients, the initial daily dosage should not exceed 2 mg in order to avoid oversedation. Elderly and debilitated patients, or those with organic brain syndrome, have been found to be prone to CNS depression after even low doses of benzodiazepines. Therefore, medication should be initiated in these patients with very low initial doses, and increments should be made gradually, depending on the patient's response, in order to avoid oversedation or neurological impairment. Extreme care must be used in administering lorazepam injection to elderly patients, very ill patients, and to patients with limited pulmonary reserve, because of the possibility that underventilation and/or hypoxic cardiac arrest may occur. Resuscitative equipment for ventilatory support should be readily available.

Usage in Children:: Safety and effectiveness of Lorazepam in children of less than 12 years have not been established.

Information for the Patient: To assure the safe and effective use of Lorazepam, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Essential Laboratory Tests: Some patients on Lorazepam have developed leukopenia, and some have had elevations of LDH. As with other benzodiazepines, periodic blood counts and liver-function tests are recommended for patients on long-term therapy.

Both elevation and lowering of blood sugar levels have been reported.

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Drug Interactions

Clinically Significant Drug Interactions: The benzodiazepines, including Lorazepam, produce CNS-depressant effects when administered with such medications as barbiturates or alcohol.

Lorazepam injection, like other injectable benzodiazepines, produces depression of the central nervous system when administered with ethyl alcohol, phenothiazines, barbiturates, MAO inhibitors, and other antidepressants.When scopolamine is used concomitantly with injectable lorazepam, an increased incidence of sedation, hallucinations, and irrational behavior has been observed.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes clozapine, valproic acid, and medicines used to treat moderate to severe pain. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

Adverse reactions, if they occur, are usually observed at the beginning of therapy and generally disappear on continued medication or upon decreasing the dose. In a sample of about 3,500 anxious patients, the most frequent adverse reaction to Lorazepam is sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). Less frequent adverse reactions are disorientation, depression, nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms, eye-function disturbance, together with various gastrointestinal symptoms and autonomic manifestations. The incidence of sedation and unsteadiness increased with age.

Small decreases in blood pressure have been noted but are not clinically significant, probably being related to the relief of anxiety produced by Lorazepam.

Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.

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Overdose

In the management of overdosage with any drug, it should be kept 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, and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, sypmtoms may include ataxia, hypotonia, hypotension, hypnotic state, stage one (1) to three (3) coma, and very rarely, death.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Induced vomiting and/or gastric lavage should be undertaken, followed by general supportive care, monitoring of vital signs, and close observation of the patient. Hypotension, though unlikely, usually may be controlled with Levarterenol Bitartrate Injection, USP. The usefulness of dialysis has not been determined.

Vital signs and fluid balance should be carefully monitored. An adequate airway should be maintained and assisted respiration used as needed. With normally functioning kidneys, forced diureses with intravenous fluids and electrolytes may accelerate elimination of benzodiazepines from the body. In addition, osmotic diuretics, such as mannitol, may be effective as adjunctive measures. In more critical situations, renal dialysis and exchange blood transfusions may be indicated.

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Dosage

Several days to weeks may pass before you feel the full benefit of this medicine.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, away from heat and light.
  • If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

Dosage must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment. As with other anxiolytic sedatives, short courses of treatment should usually be the rule for the symptomatic relief of disabling anxiety in psychoneurotic patients and the initial course of treatment should not last longer than 1 week without reassessment of the need for a limited extension. Initially, not more than 1 week's supply of the drug should be provided and automatic prescription renewals should not be allowed. Subsequent prescriptions, when required, should be limited to short courses of therapy.

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.

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How Supplied

Tablets:: Lorazepam Tablets are available in the following dosage strengths: 0.5 mg, 1 mg, 2 mg.

Ativan Patient Information Sheet (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Anxiety Disorders

Detailed Info on Signs, Symptoms, Causes, Treatments of Depression


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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