Lorazepam 0 5 mg

Ativan

Generic Name: lorazepam
Product Name: Ativan

Indication: What Ativan is used for

Ativan is used to relieve anxiety. However, anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

It is also used before surgery to help relax you.

In general, benzodiazepines such as Ativan should be taken for short periods only (for example 2-4 weeks). Continuous long-term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

Ask your doctor if you have any questions about why Ativan has been prescribed for you. Your doctor may have prescribed it for another purpose.

This medicine is available only with a doctor’s prescription.

Action: How Ativan works

Ativan contains lorazepam as the active ingredient which belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.

The exact mechanism of action of benzodiazepines has not yet been elucidated; however, benzodiazepines appear to work through several mechanisms. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system either by potentiating the effects of synaptic or pre-synaptic inhibition mediated by gamma-aminobutyric acid or by directly affecting the action potential generating mechanisms.

Each Ativan 1 mg tablet contains 1 mg lorazepam.

Each Ativan 2.5 mg tablet contains 2.5 mg lorazepam.

It also contains the inactive ingredients magnesium stearate, cellulose-microcrystalline, polacrilin potassium, lactose, iron oxide yellow (2.5 mg only), and quinoline yellow (2.5 mg only).

Ativan does not contain gluten, sucrose, tartrazine or any other azo dyes.

Dose advice: How to use Ativan

Before you take it

When you must not take it

Do not take Ativan if:

  • You are allergic to:
    • Lorazepam or any of the ingredients listed here;
    • Any other medicine from the benzodiazepine group of medicines.
  • You have severe and chronic lung disease;
  • You have sleep apnoea, a condition where you have breathing problems when you sleep;
  • You are depressed with or without anxiety problems. Lorazepam can increase thoughts of death or suicide.

Do not take Ativan if the packaging is torn or shows signs of tampering.

Do not take Ativan after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well or have no effect at all.

Do not give this medicine to children unless advised by the child’s doctor. The safety and effectiveness of Ativan in children under 16 years have not been established.

You must tell your doctor if:

  • You have any allergies to:
    • Any other medicines;
    • Any other substances, such as foods, preservatives or dyes;
  • You are pregnant or planning to become pregnant.
    • Do not take Ativan if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits involved;
  • You are breastfeeding or plan to breastfeed.
    • Do not take Ativan if you are breastfeeding or planning to breastfeed unless you and your doctor have discussed the risks and benefits involved;
  • You have or have had any other medical conditions including:
    • Liver, kidney or lung disease;
    • Blood disorders;
    • Fits or convulsions;
    • Severe muscle weakness known as myasthenia gravis;
    • Low blood pressure;
    • Glaucoma (high pressure in the eye);
    • Depression, psychosis or schizophrenia.
  • You drink alcohol regularly.
    • Alcohol may increase the effects of Ativan.

If you have not told your doctor about any of the above, tell them before you take any Ativan.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with Ativan. These include:

  • Other sleeping tablets, sedatives or tranquillisers;
  • Medicines for depression;
  • Medicines for allergies for example antihistamines or cold tablets;
  • Pain relievers;
  • Muscle relaxants;
  • Medicines to control fits.

These medicines may increase the effects of Ativan. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking Ativan.

How to take it

How much to take

The dose of Ativan may be different for each person. Your doctor will decide the right dose for you.

For anxiety, the usual daily dose is 2 to 3 mg administered in divided doses. However, the daily dose can range from 1 to 10 mg.

For sleeping problems (insomnia) due to anxiety, a dose of 1 to 2 mg taken at bedtime is usually prescribed.

If you are taking Ativan before surgery the usual dose is 2 to 4 mg the night before surgery. Another dose of 2 to 4 mg may also be given 1 to 2 hours before surgery.

Elderly people may need a lower dose.

Swallow Ativan with a glass of water.

It may be taken with or without food.

When to take it

Your doctor will tell you how many times during the day you need to take Ativan.

How long to take it

Do not take Ativan for longer than your doctor says.

Ativan is usually used for short periods only (for example 2-4 weeks). Continuous long-term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

Continue taking Ativan as long as your doctor recommends it.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed. If you have missed more than two doses in a row, speak to your doctor or pharmacist.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

If you are taking Ativan for insomnia due to anxiety and forget to take Ativan before you go to bed, do not take any Ativan if you wake up late in the night or early morning. Taking Ativan late at night or early in the morning may make it hard for you to wake in the morning. If you have any questions about this, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (in Australia telephone 13 11 26, in New Zealand telephone 0800 764 766) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much Ativan. Do this even if there are no signs of discomfort or poisoning. Also, report any other medicine or alcohol which has been taken. You may need urgent medical attention.

If you take too much Ativan you may feel drowsy, confused, tired, dizzy, have difficulty breathing, feel weak or become unconscious.

While you are taking it

Things you must do

Take Ativan exactly as your doctor has prescribed.

Tell all doctors, dentists, and pharmacists who are treating you that you are taking Ativan.

If you become pregnant while you are taking Ativan, tell your doctor immediately.

Tell your doctor if you feel Ativan is not helping your condition.

If you are being treated for anxiety, be sure to discuss with your doctor any problems you may have and how you feel, especially if your anxiety attacks are getting worse or more frequent. This will help your doctor to determine the best treatment for you.

Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking Ativan.

Always discuss with your doctor any problems or difficulties you have during or after taking Ativan.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough Ativan to last weekends and holidays.

Things you must not do

Do not drive or operate machinery until you know how Ativan affects you. This medicine may cause drowsiness or dizziness in some people and therefore may affect alertness. Make sure you know how you react to Ativan before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert. Even if you take Ativan at night, you may still be drowsy or dizzy the next day.

Do not take Ativan for a longer time than your doctor has prescribed. Ativan should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.

Do not change your dose without first checking with your doctor.

Do not stop taking Ativan or lower the dose, without first checking with your doctor. Stopping this medicine suddenly may cause some unwanted effects. Your doctor will slowly reduce your dose before you can stop taking it completely.

Do not suddenly stop taking Ativan if you suffer from epilepsy. Stopping this medicine suddenly may make your epilepsy worse.

Do not use this medicine to treat any other complaints unless your doctor says to.

Do not give Ativan to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful when drinking alcohol while taking Ativan. Combining Ativan and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking Ativan.

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness, and unsteadiness, which may increase the risk of a fall.

After taking it

Storage

Keep Ativan in a cool dry place where the temperature stays below 25°C.

Keep your tablets in their blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.

Do not store it or any other medicines, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Ativan or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

Schedule of Ativan

Ativan is an S4 (prescription only) medicine.

Side effects of Ativan

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Ativan. Ativan helps most people with anxiety but it may have unwanted side effects in some people. All medicines may have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If side effects do happen, they are more likely to happen when you first start taking Ativan. These side effects may go away during treatment as your body adjusts to the dose.

However, tell your doctor if you notice any of the following and they worry you:

  • Drowsiness;
  • Dizziness;
  • Sleepiness;
  • Clumsiness or unsteadiness;
  • Weakness;
  • Loss of memory.

These are the more common side effects of Ativan.

Other less common or rare side effects include:

  • Skin rashes;
  • Feeling sick or vomiting;
  • Outbursts of anger and increased excitement;
  • Confusion or depression;
  • Headache;
  • Sleep disturbances;
  • Blurred vision;
  • Low blood pressure;
  • Dry mouth;
  • Excessive salivation;
  • Changes in appetite;
  • Nausea.

Tell your doctor if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking, Ativan. Other side effects not listed above may occur in some people.

Ask your doctor or pharmacist if there is anything you don’t understand.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

For further information talk to your doctor.

ATIVAN (lorazepam) Dosage And Administration

Dosage And Administration

DOSAGE: The dosage and duration of therapy of Ativan (lorazepam) must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment.

As with other anxiolytic sedatives, short courses of treatment should usually be the rule for the symptomatic relief of disabling anxiety in psychoneurotic patients and the initial course of treatment should not last longer than one week without reassessment of the need for a limited extension. Initially, not more than one week’s supply of the drug should be provided and automatic prescription renewals should not be allowed. Subsequent prescriptions, when required, should be limited to short courses of therapy.

The lowest effective dose of Ativan (lorazepam) should be prescribed for the shortest duration possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore the drug should be discontinued gradually. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of lorazepam should be avoided and a gradual, dose-tapering schedule followed after extended therapy.

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.

Generalized Anxiety Disorder: The recommended initial adult daily oral dosage is 2 mg in divided doses of 0.5, 0.5 and 1 mg, or of 1 mg and 1 mg. The daily dosage should be carefully increased or decreased by 0.5 mg depending upon tolerance and response. The usual daily dosage is 2 to 3 mg. However, the optimal dosage may range from 1 to 4 mg daily in individual patients. Usually, a daily dosage of 6 mg should not be exceeded.

In elderly and debilitated patients, the initial daily dose should not exceed 0.5 mg and should be very carefully and gradually adjusted, depending upon tolerance and response.

Excessive Anxiety Prior to Surgical Procedures: Adults: Usually 0.05 mg/kg to a maximum of 4 mg total, given by the sublingual route 1 to 2 hours before surgery. As with all premedicant drugs, the dose should be individualized. Doses of other central nervous system depressant drugs should be ordinarily reduced.

ADMINISTRATION: The sublingual tablet, when placed under the tongue, will dissolve in approximately 20 seconds. The patients should not swallow for at least 2 minutes to allow sufficient time for absorption.

About lorazepam

Type of medicine A benzodiazepine
Used for Anxiety; insomnia associated with anxiety; as pre-medication before surgery or medical procedures; acute panic attacks; convulsions
Available as Tablets and injection

Lorazepam works by affecting the way certain substances in your brain (called neurotransmitters) pass messages to your brain cells. It has a calming effect on various functions of your brain.

The calming effect is helpful in a variety of conditions which can be caused by anxiety, such as panic attacks and difficulties sleeping. The calming effect is also used to relax and/or sedate people who are having certain medical investigations or treatments. It is given as a pre-med, particularly during procedures that can cause anxiety or discomfort. The calming action also helps to relax muscles, so lorazepam injection is used to treat fits, such as those caused by epilepsy.

Before taking lorazepam

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking lorazepam it is important that your doctor knows:

  • If you are pregnant or breastfeeding.
  • If you have any breathing problems.
  • If you have any problems with the way your liver works, or if you have any problems with the way your kidneys work.
  • If you have a mental health problem. This includes conditions such as psychosis, depression, obsessive conditions, phobias and personality disorders.
  • If you have ever had a drug or alcohol addiction.
  • If you have a condition causing severe muscle weakness, called myasthenia gravis.
  • If you have ever had an allergic reaction to a medicine.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

How to take lorazepam

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about lorazepam, and will also provide you with a full list of the side-effects which you could experience from taking it.
  • Take lorazepam exactly as your doctor tells you to – the dose will be individualised to suit your needs. The directions for taking the tablets will be printed on the label of the pack to remind you about what the doctor said to you. You could be asked to take just one single dose (if it is before a medical procedure, for example), or to take regular doses for a short while. If you are to take lorazepam regularly for anxiety, you will probably be prescribed two or three doses to take a day. If you are taking it because you are having difficulty sleeping, you will be prescribed a dose to take at bedtime only. The course of treatment prescribed will be as short as possible. If you have any questions about how to take the tablets, please ask your doctor or pharmacist for further advice.
  • Try to take your doses of lorazepam at the same times of day each day, as this will help you to remember to take them. Swallow the tablet(s) with a drink of water. You can take lorazepam either with or without food.
  • If you forget to take a dose at the usual time, take it when you remember. Try to take the correct number of doses each day, but do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

  • Remember to keep any follow-up appointments with your doctor. This is so your doctor can check on your progress.
  • Lorazepam is likely to affect your reactions and ability to drive. It is an offence to drive while your reactions are impaired. Do not drive until you know how you react, especially when you first start treatment. Please also be aware that the effects of lorazepam can last into the following day. Even if your driving ability is not impaired, should you drive, you are advised to carry with you some evidence that the medicine has been prescribed for you – a repeat prescription form or a patient information leaflet from the pack is generally considered suitable.
  • You should not drink alcohol while you are on lorazepam. It will increase the risk of sedative side-effects.
  • Lorazepam is taken for short periods of time only, often for just a few days. It will not be for longer than four weeks, as this may lead to you feeling dependent on it. Also, your body gets used to it quickly, and after this time it is unlikely to have the same effect.
  • It is possible that drinking grapefruit juice can increase the amount of lorazepam in your bloodstream, which may increase the risk of side-effects. It is probably best to avoid drinking grapefruit juice while you are taking lorazepam.
  • If you are due to have an operation or any dental treatment, please tell the person carrying out the treatment that you are taking lorazepam. This is because lorazepam increases the effects of some anaesthetics.
  • Your doctor could recommend that you reduce your dose of lorazepam gradually when it is time to stop taking it. This is to reduce the risk of you experiencing withdrawal effects. Follow carefully any instructions your doctor gives to you.

Can lorazepam cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the more common ones associated with lorazepam. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer’s printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer’s information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common lorazepam side-effects What can I do if I experience this?
Feeling sleepy, weak, or light-headed (these can continue into the following day) Do not drive and do not use tools or machines. Do not drink alcohol
Forgetfulness, feeling confused or unsteady If any of these become troublesome, speak with your doctor
Feeling (or being) aggressive This can happen in some people – let your doctor know about it as soon as possible

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store lorazepam

  • Keep all medicines out of the sight and reach of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

If you buy any medicines check with a pharmacist that they are safe to take with your other medicines.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Alprazolam (Xanax®) versus Lorazepam (Ativan®)

Based on “Essential Psychopharmacology”
written by Stephen M. Stahl, MD, PhD

Which is stronger Ativan® or Xanax®?

Many people wonder is lorazepam stronger than alprazolam. Alprazolam (Xanax) is more potent benzodiazepine than Lorazepam (Ativan).

How many mg of Ativan® equals Xanax®?

It should be noted that potency equivalence between benzodiazepine drugs is not clearly established.

The approximate equivalent dose of lorazepam to 10 mg diazepam: 1.7 mg 1.

The approximate equivalent dose of alprazolam to 10 mg diazepam: 1 mg 1.

So alprazolam 1 mg is equipotent to lorazepam 1.7 mg.

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Can you mix Ativan® and Xanax®?

There are no strict contraindications regarding the use of two benzodiazepines. Concomitant use of two different benzodiazepines is exceedingly rare in practice and is not recommended. If you have questions regarding the medications prescribed to you, please check with your doctor.

Difference between Alprazolam and Lorazepam chart

From the comparison chart below you can see what is common and what is different between the two benzos:

Alprazolam Lorazepam
• Xanax ®
• Xanax XR®
• Ativan®
Drug class
Benzodiazepines,
Anti-anxiety drugs
Dose formulations
• Tablets
• Tablets, extended-release
• Tablets, orally disintegrating
• Oral solution
• Tablets
• Oral concentrate
• Injectable solution
Legal status
• Controlled substance, Schedule IV
• Prescription only
FDA-approved indications
• Anxiety disorder
• Panic attacks
• Excessive anxiety
• Status epilepticus
• Pre-anesthetic for preoperative sedation and anxiety relief
“Off-label” uses
• Premenstrual syndrome • Panic disorder
• Acute mania
• Social anxiety disorder
• Depression (fast improvement of symptoms) 2
• Dental work and other surgical procedures to relax the patient
• Decrease of alcohol and sedative-hypnotic withdrawal symptoms
• Insomnia
Mechanism of action
• All benzodiazepines have a common molecular structure and similar mechanism of action.
• Benzodiazepines work by stimulating the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the CNS.
Half-life
• 11.2 hours • 12-15 hours
Oral bioavailability
• 90%, well-absorbed orally • 90%, well-absorbed orally
Metabolism, Elimination
• Alprazolam is metabolized by the liver, primarily by cytochrome CYP3A4.
It is metabolized to two major metabolites: 4-hydroxyalprazolam and α-hydroxyalprazolam.
• Alprazolam and its metabolites are excreted primarily by kidneys and some via feces.
• Metabolism of lorazepam is different from other benzodiazepines as it is metabolized in the liver by the process of glucuronidation.
• Lorazepam is not metabolized by cytochrome P450 enzymes.
• Lorazepam is extensively conjugated to the 3- O-phenolic glucuronide in the liver and undergoes enterohepatic recirculation.
• 88% of lorazepam is excreted in the urine (with 75% excreted as the glucuronide) and 7% in feces.
Contraindications
• Concomitant use with CYP3A4 inhibitors (e.g. itraconazole, ketoconazole) • Myasthenia gravis
• Hypersensitivity to benzodiazepines
• Acute narrow angle glaucoma
Warnings & precautions
• Risk of dependence
• Tolerance – long term use leads to tolerance and reduced therapeutic effect
• Withdrawal symptoms upon discontinuation of a drug
• Depression of CNS function
• Daytime sedation
• Amnesiac effects – high benzodiazepine doses may cause amnesia
Side effects
• Drowsiness
• Sedation
• Somnolence
• Fatigue
• Weakness
• Lightheadedness
• Memory impairment, confusion
• Impaired motor coordination
Pregnancy category
• D

From the analysis of clinical trials you can conclude which medication is better for a specific medical condition.

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Alprazolam vs Lorazepam for Panic Attacks

Important distinction here is that Xanax® has FDA approval for treatment of panic disorder, while Ativan® has not.

Lorazepam is as effective as alprazolam in the acute treatment of panic disorder5, 6.

Alprazolam vs Lorazepam for Sleep and Insomnia

Both alprazolam and lorazepam are used to treat sleep problems “off-label”. Benzodiazepines reduce sleep onset latency (time to get to sleep), decreased duration of slow-wave sleep, and improve sleep quality.

Lorazepam dosage for insomnia from anxiety: 2-4 mg at bedtime.

Alprazolam dosage for insomnia: 0.25-1 mg at bedtime7.

The utility of alprazolam and lorazepam in the treatment of sleep problems is limited by a relatively rapid development of tolerance to hypnotic effects and occurrence of rebound insomnia8.

Alprazolam advantages over Lorazepam

Is Alprazolam better than Lorazepam?

  • Alprazolam appears to be a more appropriate benzodiazepine for treating immunocompromised patients3.
  • Lorazepam provides more significant prolongation of reaction time, while alprazolam produces less impairment4.
  • Alprazolam is absorbed more rapidly and produces a quick anxiolytic effect.

Lorazepam advantages over Alprazolam

Is Lorazepam better than Alprazolam?

  • Lorazepam is a bit less addictive than alprazolam.
  • Lorazepam is considered to be best tolerated benzodiazepine by patients with liver disease.
  • Lorazepam is metabolized solely through conjugation and has fewer CYP450 drug interactions.

Further reading

    • Clonazepam (Klonopin) vs Lorazepam (Ativan)
    • Alprazolam (Xanax) vs Hydroxyzine (Vistaril)
    • Alprazolam (Xanax) vs Zolpidem (Ambien)
    • Anti Anxiety Benzodiazepines List
  • 1. Kroll DS, Nieva HR, Barsky AJ, Linder JA. Benzodiazepines are Prescribed More Frequently to Patients Already at Risk for Benzodiazepine-Related Adverse Events in Primary Care. J Gen Intern Med. 2016 Sep;31(9):1027-34 PubMed
  • 2. Laakman G, Faltermaier-Temizel M, Bossert-Zaudig S, Baghai T, Lorkowski G. Treatment of depressive outpatients with lorazepam, alprazolam, amytriptyline and placebo. Psychopharmacology (Berl). 1995 Jul;120(1):109-15.
  • 3. Covelli V, Maffione AB, Greco B, Cannuscio B, Calvello R, Jirillo E.In vivo effects of alprazolam and lorazepam on the immune response in patients with migraine without aura. Immunopharmacol Immunotoxicol. 1993 Aug;15(4):415-28.)
  • 4. Crombez G, Kupers R, Adriaensen H.The effects of a single oral dose of lorazepam and alprazolam on reaction times in young healthy volunteers. Acta Anaesthesiol Belg. 1991;42(2):79-84.
  • 5. Schweizer E, Pohl R, Balon R, Fox I, Rickels K, Yeragani VK. Lorazepam vs. alprazolam in the treatment of panic disorder. Pharmacopsychiatry. 1990 Mar;23(2):90-3.
  • 6. Charney DS, Woods SW. Benzodiazepine treatment of panic disorder: a comparison of alprazolam and lorazepam. J Clin Psychiatry. 1989 Nov;50(11):418-23.
  • 7. Bonnet MH, Kramer M, Roth T. A dose response study of the hypnotic effectiveness of alprazolam and diazepam in normal subjects. Psychopharmacology (Berl). 1981;75(3):258-61.
  • 8. Kales A, Bixler EO, Vela-Bueno A, Soldatos CR, Manfredi RL. Alprazolam: effects on sleep and withdrawal phenomena. J Clin Pharmacol. 1987 Jul;27(7):508-15. PubMed

Published: April 05, 2018
Last updated: July 07, 2018

PRECAUTIONS

In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy.

Lorazepam should be used with caution in patients with compromised respiratory function (e.g. COPD, sleep apnea syndrome).

Elderly or debilitated patients may be more susceptible to the sedative effects of lorazepam. Therefore, these patients should be monitored frequently and have their dosage adjusted carefully according to patient response; the initial dosage should not exceed 2 mg.

Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

The usual precautions for treating patients with impaired renal or hepatic function should be observed. As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy; therefore, lorazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy. Dosage for patients with severe hepatic insufficiency should be adjusted carefully according to patient response; lower doses may be sufficient in such patients.

In patients where gastrointestinal or cardiovascular disorders coexist with anxiety, it should be noted that lorazepam has not been shown to be of significant benefit in treating the gastrointestinal or cardiovascular component.

Esophageal dilation occurred in rats treated with lorazepam for more than one year at 6 mg/kg/day. The no-effect dose was 1.25 mg/kg/day (approximately 6 times the maximum human therapeutic dose of 10 mg per day). The effect was reversible only when the treatment was withdrawn within two months of first observation of the phenomenon. The clinical significance of this is unknown. However, use of lorazepam for prolonged periods and in geriatric patients requires caution, and there should be frequent monitoring for symptoms of upper G.I. disease.

Safety and effectiveness of Ativan (lorazepam) in children of less than 12 years have not been established.

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.

Carcinogenesis And Mutagenesis

No evidence of carcinogenic potential emerged in rats during an 18-month study with Ativan (lorazepam). No studies regarding mutagenesis have been performed.

Pregnancy

Reproductive studies in animals were performed in mice, rats, and two strains of rabbits. Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to dosage. Although all of these anomalies were not present in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg and higher, there was evidence of fetal resorption and increased fetal loss in rabbits which was not seen at lower doses.

The clinical significance of the above findings is not known. However, an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because the use of these drugs is rarely a matter of urgency, the use of lorazepam during this period should be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.

In humans, blood levels obtained from umbilical cord blood indicate placental transfer of lorazepam and lorazepam glucuronide. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery.

Nursing Mothers

Lorazepam has been detected in human breast milk; therefore, it should not be administered to breastfeeding women, unless the expected benefit to the woman outweighs the potential risk to the infant.

Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines. Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).

Geriatric Use

Clinical studies of Ativan generally were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects; however, the incidence of sedation and unsteadiness was observed to increase with age (see ADVERSE REACTIONS).

Age does not appear to have a significant effect on lorazepam kinetics (see CLINICAL PHARMACOLOGY).

Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, and lower doses may be sufficient in these patients (see DOSAGE AND ADMINISTRATION).

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