Lorazepam (Page 3 of 3)

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 mg/day to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 mg/day to 10 mg/day.

For anxiety, most patients require an initial dose of 2 mg/day 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 mg to 4 mg may be given, usually at bedtime.

For elderly or debilitated patients, an initial dosage of 1 mg/day 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.

HOW SUPPLIED

Lorazepam Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of lorazepam, USP.

The 0.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 321 on the other side. They are available as follows:

NDC 51079-417-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 1 mg tablets are white to off-white, round, scored tablets debossed with MYLAN above the score and 457 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-386-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 2 mg tablets are white to off-white, round, scored tablets debossed with MYLAN above the score and 777 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-387-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

PHARMACIST: Dispense a Medication Guide with each prescription.

Medication Guide

Lorazepam Tablets, USP CIV (lor az’ e pam)

What is the most important information I should know about lorazepam tablets?

  • Lorazepam tablets are 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.
  • 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 affect 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.
  • Do not take more lorazepam tablets 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 (C-IV) because it can be abused or lead to dependence. Keep lorazepam tablets in a safe place to prevent misuse or 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 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 it. Your healthcare provider will tell you how many lorazepam tablets to take and when to take it.
  • If you take too many lorazepam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking lorazepam tablets?

  • Lorazepam tablets can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how lorazepam tablets affect you.
  • You should not drink alcohol while taking lorazepam tablets. Drinking alcohol can increase your chances of having serious side effects.

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?”
  • Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam tablets.
  • Abuse and Dependence. Taking lorazepam tablets can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Withdrawal Symptoms. You may have withdrawal symptoms if you stop taking lorazepam tablets suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping lorazepam tablets to avoid withdrawal symptoms.

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 in a tightly closed container at 20° to 25°C (68° to 77°F). Protect from light.
  • 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, microcrystalline cellulose, polacrilin potassium and sodium stearyl fumarate.

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

This Medication Guide has been approved by the U.S. Food and Drug Administration

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12193 R1
9/17

PRINCIPAL DISPLAY PANEL — 0.5 mg

NDC 51079-417-20

Lorazepam
Tablets, USP
CIV
0.5 mg

100 Tablets (10 x 10)

Each tablet contains:
Lorazepam, USP . . . . 0.5 mg

Usual Dosage: One to six mg
per day, given in divided doses.
See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-9450 R2

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Lorazepam 0.5 mg Tablets C-IV Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mg

NDC 51079-386-20

Lorazepam
Tablets, USP
CIV
1 mg

100 Tablets (10 x 10)

Each tablet contains:
Lorazepam, USP . . . . 1 mg

Usual Dosage: One to six mg
per day, given in divided doses.
See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-9452 R2

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Lorazepam 1 mg Tablets C-IV Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 mg

NDC 51079-387-20

Lorazepam
Tablets, USP
CIV
2 mg

100 Tablets (10 x 10)

Each tablet contains:
Lorazepam, USP . . . . 2 mg

Usual Dosage: One to six mg
per day, given in divided doses.
See accompanying prescribing
information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-9456 R2

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Lorazepam 2 mg Tablets C-IV Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LORAZEPAM lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-417(NDC:0378-2321)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code M;321
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-417-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-417-01)
1 NDC:51079-417-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-417-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077657 12/27/2006
LORAZEPAM lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-386(NDC:0378-2457)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code MYLAN;457
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-386-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-386-01)
1 NDC:51079-386-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-386-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077657 12/29/2006
LORAZEPAM lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-387(NDC:0378-2777)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (LORAZEPAM) LORAZEPAM 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POLACRILIN POTASSIUM
SODIUM STEARYL FUMARATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code MYLAN;777
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-387-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-387-01)
1 NDC:51079-387-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-387-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077657 12/28/2006
Labeler — Mylan Institutional Inc. (039615992)

Revised: 12/2018 Mylan Institutional Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.