Pronunciation:

lor-AZ-e-pam

Brand Names:

• Ativan
• Lorazepam Intensol
• Loreev XR

Dosage Forms:

• Tablet
• Solution
• Capsule, Extended Release

Warnings:

Risks From Concomitant Use With Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions:Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including lorazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing lorazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including lorazepam may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage .

Classifications:

Therapeutic—

Antianxiety

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

Lorazepam is used to treat anxiety disorders. It is also used for short-term relief of the symptoms of anxiety or anxiety caused by depression. Lorazepam is a benzodiazepine that works in the brain to relieve symptoms of anxiety. Benzodiazepines are central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lorazepam tablets and oral liquid in children younger than 12 years of age and extended-release capsules in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lorazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness or unsteadiness) and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clobazam
• Clonazepam
• Codeine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Dezocine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Doxylamine
• Esketamine
• Ethchlorvynol
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Ivacaftor
• Ketamine
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Opium
• Opium Alkaloids
• Orlistat
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Piritramide
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Tilidine
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Posaconazole
• Probenecid
• Pyrimethamine
• Rifapentine
• St John's Wort
• Theophylline
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, or history of or
• Lung or breathing problems (eg, COPD, respiratory depression, sleep apnea) or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Depression or
• Mental problems (eg, psychosis)—Use is not recommended in patients with these conditions.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

Swallow the extended-release capsule whole. Do not crush, break, or chew it. If you cannot swallow the extended-release capsule, you may open it and sprinkle the medicine onto a tablespoon of applesauce. Stir this mixture well and swallow it without chewing. Drink water after swallowing the mixture. Take the mixture within 2 hours of mixing. Do not store for future use.

Measure the oral liquid using the marked medicine dropper that comes with the package. Dilute each dose with water, juice, soda, applesauce and puddings.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (oral solution):
  • For anxiety:
    • Adults and children 12 years of age and older—2 to 6 milligrams (mg) in divided doses per day. Your doctor may adjust your dose as needed.
    • Older adults—At first, 1 to 2 mg in divided doses per day. Your doctor may adjust your dose as needed.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For anxiety:
    • Adults and children 12 years of age and older—At first, 2 to 3 milligrams (mg) in divided doses per day. Your doctor may adjust your dose as needed.
    • Older adults—At first, 1 to 2 mg in divided doses per day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For insomnia caused by anxiety or transient situational stress:
    • Adults and children 12 years of age and older—2 to 4 milligrams (mg) taken as a single dose at bedtime. Your doctor may adjust your dose as needed.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release capsules):
  • For anxiety:
    • Adults—One capsule once a day in the morning. Dose is based on the total daily dose of lorazepam tablets, which you take three times a day in equally divided doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to see if this medicine is working and allow for changes in the dose. Blood tests may be needed to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later part of a pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you develop any unusual and strange thoughts or behavior while you are taking lorazepam be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), thoughts of killing oneself, and unusual excitement, nervousness, or irritability.

This medicine may cause drowsiness, trouble with thinking, trouble with controlling movements, or trouble with seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Symptoms of an overdose include: blurred vision, change in consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hallucinations, increased sweating, loss of consciousness, loss of strength or energy, muscle pain or weakness, nightmares, shakiness and unsteady walk, slow or irregular heartbeat, sweating, trouble in speaking, unsteadiness, trembling, or other problems with muscle control or coordination, trouble sleeping, unusual excitement, nervousness, restlessness, or irritability, or unusual tiredness or weakness. Call your doctor right away if you notice these symptoms.

This medicine may cause respiratory depression (serious breathing problem that can be life-threatening), especially when used with narcotic pain medicines. Tell your doctor if you are using any narcotic medicine.

Do not stop taking it without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including hallucinations, headache, seizures, stomach or muscle cramps, tremors, trouble sleeping, or unusual behavior.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Drowsiness

relaxed and calm

sleepiness

Incidence not known

Aggressive, angry

agitation

attack, assault, or force

black, tarry stools

bleeding gums

blood in the urine or stools

bluish lips or skin

blurred vision

change in consciousness

chest tightness

chills

coma

confusion

confusion about identity, place, and time

cough or hoarseness

dark urine

decreased urine output

difficulty with breathing or swallowing

difficulty with speaking

discouragement

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drooling

dry mouth

excitation

false or unusual sense of well-being

fast or irregular heartbeat

feeling sad or empty

fever with or without chills

general feeling of tiredness or weakness

headache

hives, itching, or rash

hyperventilation

increased thirst

irregular, fast or slow, or shallow breathing

irritability

loss of appetite

loss of balance control

loss of consciousness

loss of interest or pleasure

loss of memory

lower back or side pain

muscle pain, cramps, trembling, jerking, or stiffness

nausea or vomiting

not breathing

painful or difficult urination

pale or blue lips, fingernails, or skin

pinpoint red spots on the skin

problems with memory

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

reddening of the skin, especially around ears

restlessness

seeing, hearing, or feeling things that are not there

seizures

shaking

shuffling walk

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stiffness of the limbs

stomach pain

sweating

swelling of the eyes or inside of the nose

swelling of the face, ankles, or hands

swollen glands

thoughts or attempts at killing oneself

trouble concentrating

trouble sleeping

twisting movements of body

uncontrolled movements, especially of the face, neck, and back

unexplained bleeding or bruising

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

changes in patterns and rhythms of speech

confusion

excitement

increased sweating

irritability

loss of strength or energy

nightmares

restlessness

shakiness and unsteady walk

slurred speech

talkativeness

trouble speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual excitement, nervousness, restlessness, or irritability

unusual paleness

unusual weak feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Being forgetful

clumsiness

constipation

decreased interest in sexual intercourse

disturbed color perception

dizziness or lightheadedness

double vision

drowsiness

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

halos around lights

inability to have or keep an erection

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

lack or loss of self-control

lethargy

loss in sexual ability, desire, drive, or performance

muscle aches, twitching, or weakness

night blindness

overbright appearance of lights

rapid weight gain

sensation of spinning

shakiness in the legs, arms, hands, or feet

shivering

stupor

trembling or shaking of the hands or feet

tunnel vision

weak or feeble pulse

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.