Ativan Tablets

Name: Ativan Tablets

Warnings

Concomitant use of benzodiazepines, including Ativan, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Ativan concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Ativan than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Ativan, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Ativan is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS, Clinically Significant Drug Interactions).

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Ativan (lorazepam) is not recommended for use in patients with a primary depressive disorder or psychosis.

Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression. (See PRECAUTIONS, Clinically Significant Drug Interactions.)

Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.

As with all patients on CNS-depressant 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

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when lorazepam is used at the appropriate dose for short-term treatment. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving lorazepam or other psychotropic agents.

In general, benzodiazepines should be prescribed for short periods only (e.g., 2 to 4 weeks). Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Continuous long-term use of product is not recommended. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.

Abrupt termination of treatment may be accompanied by withdrawal symptoms. Symptoms reported following discontinuation of benzodiazepines include headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants.

There is evidence that tolerance develops to the sedative effects of benzodiazepines.

Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

Adverse Reactions

Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.

In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to Ativan (lorazepam) was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye function/visual disturbance (including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; SIADH, hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by Ativan (lorazepam).

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Ativan Tablets 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.

How is Ativan Tablets 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; NDC 0187-0063-50 – Bottles of 500 tablets; NDC 0187-0063-10 – Bottles of 1000 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 0187-0064-50 – Bottles of 500 tablets; NDC 0187-0064-10 - Bottles of 1000 tablets.

2 mg, white, five-sided (rectangular 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; NDC 0187-0065-50 – Bottles of 500 tablets; NDC 0187-0065-10 – Bottles of 1000 tablets.

BOTTLES:

Keep tightly closed.

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.

Manufactured by:
MEDA Manufacturing GmbH
Cologne, Germany 51063

For:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

Ativan is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

9508102
70012365

Rev. 12/16

Medication Guide

ATIVAN (AT-ivan)

(lorazepam) Tablets, C-IV

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. • ATIVAN 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 ATIVAN affects you. • 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. • Do not take more ATIVAN than prescribed.

What is ATIVAN?

• ATIVAN is 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 • ATIVAN is a federal controlled substance (C-IV) because it 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 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 should I avoid while taking ATIVAN?

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

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?” • Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including ATIVAN. • Abuse and dependence. Taking ATIVAN 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 ATIVAN 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 ATIVAN to avoid withdrawal symptoms.

The most common side effects of ATIVAN include:

• sedation • weakness • dizziness • 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 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°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

Manufactured by: MEDA Manufacturing GmbH, Cologne, Germany 51063 For: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. Ativan is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. For more information, call 1-800-321-4576.

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

9508102

70012365

Issued: 12/16

PRINCIPAL DISPLAY PANEL - 2.0 mg Bottle Label

NDC 0187-0065-01

Ativan®
(lorazepam)

2 mg

100 Tablets

CIV
SEALED
FOR YOUR
PROTECTION

Rx only

VALEANT

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