Ativan (Page 4 of 5)

DOSAGE AND ADMINISTRATION

Ativan (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 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 Ativan (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.

Discontinuation or Dosage Reduction of Ativan

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Ativan 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

Ativan® (lorazepam) Tablets are available in the following dosage strengths:

0.5 mg, white, five-sided (shield shape) tablet with a raised “A” on one side and “BPI” and “63” impressed on reverse side.

NDC 0187-0063-01 — Bottles of 100 tablets.

1 mg, white, five-sided (shield shape) tablet with a raised “A” on one side and “BPI” and “64” impressed on scored reverse side.

NDC 0187-0064-01 — Bottles of 100 tablets.

NDC 0187-0064-10 — Bottles of 1,000 tablets.

2 mg, white, five-sided (regular pentagon) tablet with a raised “A” and impressed “2” on one side and “BPI” and “65” impressed on scored reverse side.

NDC 0187-0065-01 — Bottles of 100 tablets.

Keep bottles tightly closed. Keep out of reach of children.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada
Ativan is a trademark of Bausch Health Companies Inc. or its affiliates.


© 2021 Bausch Health Companies Inc. or its affiliates

9644302Rev. 02/2021

Medication Guide

MEDICATION GUIDE

ATIVAN (AT-ivan)

(lorazepam) Tablets

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What is the most important information I should know about ATIVAN?

ATIVAN 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 ATIVAN with opioids affects you.
Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including ATIVAN which can lead to overdose and serious side effects including coma and death.
o
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including ATIVAN. 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.
o
You can develop an addiction even if you take ATIVAN exactly as prescribed by your healthcare provider.
o
Take ATIVAN exactly as your healthcare provider prescribed.
o
Do not share your ATIVAN with other people.
o
Keep ATIVAN in a safe place and away from children.
Physical dependence and withdrawal reactions. ATIVAN can cause physical dependence and withdrawal reactions.
o
Do not suddenly stop taking ATIVAN. Stopping ATIVAN 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.
o
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.
o
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 ATIVAN than prescribed or take ATIVAN for longer than prescribed.

What is ATIVAN?

ATIVAN is a prescription medicine used:
o
to treat anxiety disorders
o
for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression
ATIVAN is a federal controlled substance (CIV) because it contains lorazepam that can be abused or lead to dependence. Keep ATIVAN in a safe place to prevent misuse and abuse. Selling or giving away ATIVAN 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 ATIVAN is safe and effective for use in children less than 12 years of age.
It is not known if ATIVAN is safe and effective for use for longer than 4 months.

Do not take ATIVAN if you:

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

Before you take ATIVAN, 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. ATIVAN may harm your unborn baby. You and your healthcare provider should decide if you should take ATIVAN while you are pregnant.
are breastfeeding or plan to breastfeed. ATIVAN 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 ATIVAN. You should not breastfeed while taking ATIVAN.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking ATIVAN with certain other medicines can cause side effects or affect how well ATIVAN or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take ATIVAN?

Take ATIVAN exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much ATIVAN to take and when to take it.
If you take too much ATIVAN, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of ATIVAN?

ATIVAN may cause serious side effects, including:

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

The most common side effects of ATIVAN include:

• sedation • dizziness

• weakness • unsteadiness

These are not all the possible side effects of ATIVAN. 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 ATIVAN?

Store ATIVAN in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
Keep ATIVAN and all medicines out of the reach of children.

General information about the safe and effective use of ATIVAN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ATIVAN for a condition for which it was not prescribed. Do not give ATIVAN 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 ATIVAN that is written for health professionals.

What are the ingredients in ATIVAN?

Active ingredient: lorazepam

Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.

Distributed by: Bausch Health US, LLCBridgewater, NJ 08807 USAManufactured by: Bausch Health Companies Inc.Steinbach, MB R5G 1Z7, Canada

ATIVAN is a trademark of Bausch Health Companies Inc. or its affiliates. For more information, call 1-800-321-4576.

© 2021 Bausch Health Companies Inc. or its affiliates

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

Revised: 02/2021

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