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What is ATIVAN?

Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3 dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:

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.

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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.

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 (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.

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.

INDICATIONS AND USAGE

Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. 

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CONTRAINDICATIONS

Ativan (lorazepam) is contraindicated in patients with 

– hypersensitivity to benzodiazepines or to any components of the formulation. 

– acute narrow-angle glaucoma.

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.

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.

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.

HOW IT IS 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.

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.

INDICATIONS AND USAGE 

Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. 

CONTRAINDICATIONS Ativan (lorazepam) is contraindicated in patients with 

– hypersensitivity to benzodiazepines or to any components of the formulation. 

– acute narrow-angle glaucoma.

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.

Information for Patients 

To assure the safe and effective use of Ativan (lorazepam), patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. Essential Laboratory Tests Some patients on Ativan (lorazepam) have developed leukopenia, and some have had elevations of LDH. As with other benzodiazepines, periodic blood counts and liver function tests are recommended for patients on long-term therapy.

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.

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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 central nervous system 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.

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