Prescription Drug Information: Lorazepam (Page 3 of 4)
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 CNS 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. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
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 develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence).
HOW SUPPLIED
Lorazepam Tablets, USP are available in the following dosage strengths:
0.5 mg: white to off-white, unscored, round flat faced beveled edge tablet, debossed with
TV over
0.5 on one side and
5R on the other side, supplied in:
Unit dose packages of 100 (10 x 10) NDC 60687-627-01
1 mg: white to off-white, scored on both sides, round flat faced beveled edge tablet, debossed with
TV over
1 on one side and
1 over
R on the other side, supplied in:
Unit dose packages of 100 (10 x 10) NDC 60687-638-01
2 mg: white to off-white, scored on both sides, round flat faced beveled edge tablet, debossed with
TV over
2 on one side and
2 over
R on the other side, supplied in:
Unit dose packages of 100 (10 x 10) NDC 60687-649-01
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Dispense with Medication Guide
To order more Medication Guides call American Health Packaging at 1-800-707-4621.
PACKAGING INFORMATION
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Teva Pharmaceuticals as follows:
(0.5 mg / 100 UD) NDC 60687-627-01 packaged from NDC 0093-3425
(1 mg / 100 UD) NDC 60687-638-01 packaged from NDC 0093-3426
(2 mg / 100 UD) NDC 60687-649-01 packaged from NDC 0093-3427
Distributed by:
American Health Packaging
Columbus, OH 43217
8464901/0122
MEDICATION GUIDE
Dispense with Medication Guide To order more Medication Guides call American Health Packaging at 1-800-707-4621.
8464901/0122 Lorazepam (lor azʹ e pam) Tablets C-IV |
What is the most important information I should know about lorazepam tablets?
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What are lorazepam tablets?
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Do not take lorazepam tablets if you:
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Before you take lorazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking lorazepam tablets with certain other medicines can cause side effects or affect how well lorazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. |
How should I take lorazepam tablets?
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What are the possible side effects of lorazepam tablets? Lorazepam tablets may cause serious side effects, including:
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The most common side effects of lorazepam tablets include:
These are not all the possible side effects of lorazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store lorazepam tablets?
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General information about the safe and effective use of lorazepam tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lorazepam tablets for a condition for which it was not prescribed. Do not give lorazepam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about lorazepam tablets that is written for health professionals. |
What are the ingredients in lorazepam tablets? Active ingredient: lorazepam Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and polacrilin potassium |
Distributed by: American Health Packaging Columbus, OH 43217 8464901/0122 For more information about the drug product, call Teva at 1-888-838-2872. For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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