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?

  • Lorazepam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens:
  • shallow or slowed breathing
  • breathing stops (which may lead to the heart stopping)
  • excessive sleepiness (sedation)
  • Do not drive or operate heavy machinery until you know how taking lorazepam tablets with opioids affects you.
  • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including lorazepam tablets which can lead to overdose and serious side effects including coma and death.
  • Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including lorazepam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
  • You can develop an addiction even if you take lorazepam tablets exactly as prescribed by your healthcare provider.
  • Take lorazepam tablets exactly as your healthcare provider prescribed.
  • Do not share your lorazepam tablets with other people.
  • Keep lorazepam tablets in a safe place and away from children.
  • Physical dependence and withdrawal reactions. Lorazepam tablets can cause physical dependence and withdrawal reactions.
  • Do not suddenly stop taking lorazepam tablets. Stopping lorazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
  • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
  • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
  • Do not take more lorazepam tablets than prescribed or take lorazepam tablets for longer than prescribed.

What are lorazepam tablets?

  • Lorazepam tablets are a prescription medicine used:
  • to treat anxiety disorders
  • for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression
  • Lorazepam tablets are a federal controlled substance (CIV) because they contain lorazepam that can be abused or lead to dependence. Keep lorazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away lorazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if lorazepam tablets are safe and effective for use in children less than 12 years of age.
  • It is not known if lorazepam tablets are safe and effective for use for longer than 4 months.

Do not take lorazepam tablets if you:

  • are allergic to lorazepam, other benzodiazepines, or any of the ingredients in lorazepam tablets. See the end of this Medication Guide for a complete list of ingredients in lorazepam tablets.

Before you take lorazepam tablets, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have a history of drug or alcohol abuse or addiction
  • have lung disease or breathing problems (such as COPD, sleep apnea syndrome)
  • have liver or kidney problems
  • have or have had seizures
  • are pregnant or plan to become pregnant. Lorazepam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take lorazepam tablets while you are pregnant.
  • are breastfeeding or plan to breastfeed. Lorazepam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take lorazepam tablets. You should not breastfeed while taking lorazepam tablets.

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?

  • Take lorazepam tablets exactly as your healthcare provider tells you to take them. Your healthcare provider will tell you how many lorazepam tablets to take and when to take them.
  • If you take too many lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of lorazepam tablets?

Lorazepam tablets may cause serious side effects, including:

  • See “What is the most important information I should know about lorazepam tablets?”
  • Lorazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how lorazepam tablets affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking lorazepam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, lorazepam tablets may make your sleepiness or dizziness much worse.
  • Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam tablets.

The most common side effects of lorazepam tablets include:

  • sedation
  • dizziness
  • weakness
  • unsteadiness

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?

  • Store lorazepam tablets at 68° to 77°F (20° to 25°C).
  • Keep lorazepam tablets and all medicines out of the reach of children.

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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