Lorazepam 0.5mg Tablets
WARNING: This drug is a benzodiazepine. The use of a benzodiazepine drug along with opioid drugs has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and death. Opioid drugs include drugs like codeine, oxycodone, and morphine. Opioid drugs are used to treat pain and some are used to treat cough. Talk with the doctor.If you are taking this drug with an opioid drug, get medical help right away if you feel very sleepy or dizzy; if you have slow, shallow, or trouble breathing; or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up. Benzodiazepines can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose or death, especially when used along with certain other drugs, alcohol, or street drugs. Drug use disorder can happen even if you take this drug as your doctor has told you. Get medical help right away if you have changes in mood or behavior, suicidal thoughts or actions, seizures, or trouble breathing.You will be watched closely to make sure you do not misuse this drug or develop drug use disorder.Benzodiazepines may cause dependence. Lowering the dose or stopping this drug all of a sudden may cause withdrawal. This can be life- threatening. The risk of dependence and withdrawal are raised the longer you take this drug and the higher the dose. Talk to your doctor before you lower the dose or stop this drug. You will need to follow your doctor's instructions. Get medical help right away if you have trouble controlling body movements, seizures, new or worse behavior or mood changes like depression or thoughts of suicide, thoughts of harming someone, hallucinations (seeing or hearing things that are not there), losing contact with reality, moving around or talking a lot, or any other bad effects.Sometimes, withdrawal signs can last for several weeks to more than 12 months. Tell your doctor if you have anxiety; trouble with memory, learning, or focusing; trouble sleeping; burning, numbness, or tingling; weakness; shaking; muscle twitching; ringing in the ears; or any other bad effects. @ COMMON USES: It is used to treat anxiety.It is used to treat seizures.It is used to ease anxiety before surgery.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anxiolytic; Sedative-hypnotic; Anticonvulsant
Pharmacologic Class
Benzodiazepine; GABA-A receptor agonist
Pregnancy Category
Category D
FDA Approved
Jun 1977
DEA Schedule
Schedule IV
Overview
What is this medicine?
Lorazepam is a medication that helps calm your brain and nerves. It's used to treat anxiety, trouble sleeping, and sometimes seizures. It works by increasing the effects of a natural chemical in your body that helps you relax.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Avoid alcohol completely while taking this medication, as it can greatly increase drowsiness and dangerous side effects.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Do not stop taking this medication suddenly, especially if you have been taking it for a long time. This can lead to withdrawal symptoms. Your doctor will help you slowly reduce the dose.
- Inform your doctor about all other medications you are taking, especially opioids, as combining them can be very dangerous.
- This medication can be habit-forming. Use exactly as prescribed and do not share it with others.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Anxiety: 2-3 mg/day in 2-3 divided doses. Insomnia: 2-4 mg at bedtime. Premedication: 2-4 mg IM/IV 30-60 min prior to procedure. Status Epilepticus: 4 mg IV over 2-5 min, repeat once after 10-15 min if needed.
Dose Range:
0.5 - 10 mg
Condition-Specific Dosing:
anxiety:
0.5-2 mg orally 2-3 times daily, max 10 mg/day
insomnia:
2-4 mg orally at bedtime
premedication:
2-4 mg IM/IV
statusEpilepticus:
4 mg IV
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, risk of propylene glycol toxicity with IV formulation)
Infant:
Not established (use with extreme caution, risk of propylene glycol toxicity with IV formulation)
Child:
Anxiety: 0.05 mg/kg/dose (max 2 mg/dose) every 4-8 hours. Status Epilepticus: 0.05-0.1 mg/kg IV (max 4 mg/dose) over 2-5 min, may repeat once after 10-15 min.
Adolescent:
Anxiety: 0.5-2 mg orally 2-3 times daily. Insomnia: 2-4 mg orally at bedtime. Status Epilepticus: 4 mg IV over 2-5 min, repeat once after 10-15 min if needed.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment typically needed.
Moderate:
No dose adjustment typically needed.
Severe:
Use with caution; consider lower initial doses and titrate slowly. Accumulation of inactive glucuronide metabolite may occur but is generally not clinically significant.
Dialysis:
Not significantly dialyzable. No specific supplemental dose needed, but monitor for increased sedation.
Hepatic Impairment:
Mild:
No dose adjustment typically needed.
Moderate:
Use with caution; consider lower initial doses and titrate slowly.
Severe:
Use with extreme caution; significant dose reduction (e.g., 50%) may be necessary. Monitor closely for increased sedation and encephalopathy.
Pharmacology
Mechanism of Action
Lorazepam binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA)-A receptor complex in the central nervous system (CNS). This binding enhances the inhibitory effects of GABA by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuronal membrane and decreased neuronal excitability.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90% (oral)
Tmax:
Oral: 2 hours; IM: 3 hours; IV: 10-20 minutes
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.8-1.3 L/kg
ProteinBinding:
Approximately 85%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (mean 12 hours)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as inactive glucuronide conjugate)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Oral: 15-60 minutes; IM: 15-30 minutes; IV: 1-5 minutes
PeakEffect:
Oral: 2-4 hours; IM: 2-4 hours; IV: 10-20 minutes
DurationOfAction:
6-8 hours (sedative effects), up to 24 hours (anxiolytic effects)
Safety & Warnings
BLACK BOX WARNING
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use 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.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Changes in balance
Feeling confused
Feeling nervous and excitable
Restlessness
Trouble sleeping
Increased interest in sex
Memory problems or loss
Severe dizziness or fainting
Changes in eyesight
Muscle weakness
Dark urine or yellow skin and eyes
This medication can also cause severe and potentially life-threatening breathing problems. If you experience slow, shallow, or difficult breathing, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
* Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Changes in balance
Feeling confused
Feeling nervous and excitable
Restlessness
Trouble sleeping
Increased interest in sex
Memory problems or loss
Severe dizziness or fainting
Changes in eyesight
Muscle weakness
Dark urine or yellow skin and eyes
This medication can also cause severe and potentially life-threatening breathing problems. If you experience slow, shallow, or difficult breathing, contact your doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
* Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow or shallow breathing
- Severe dizziness or lightheadedness
- Confusion or unusual thoughts/behavior
- Slurred speech
- Loss of coordination or balance
- Yellowing of skin or eyes (jaundice)
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Depression or specific mental health issues
+ Sleep apnea or breathing difficulties
+ Kidney disease or liver disease
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Depression or specific mental health issues
+ Sleep apnea or breathing difficulties
+ Kidney disease or liver disease
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Additionally, avoid consuming alcohol while taking this medication, as it may exacerbate its effects.
Before using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) drugs that may cause drowsiness or slow your reactions, consult with your doctor. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
Adhere to your doctor's prescribed dosage and duration of treatment. Do not take this medication for an extended period beyond what your doctor has recommended. Prolonged use or high doses may lead to tolerance, reducing the drug's effectiveness. If you experience a decrease in the medication's efficacy, contact your doctor. Do not exceed the prescribed dose, as this may increase the risk of adverse effects.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in pediatric populations.
This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
If you are breast-feeding or plan to breast-feed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
Before using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) drugs that may cause drowsiness or slow your reactions, consult with your doctor. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
Adhere to your doctor's prescribed dosage and duration of treatment. Do not take this medication for an extended period beyond what your doctor has recommended. Prolonged use or high doses may lead to tolerance, reducing the drug's effectiveness. If you experience a decrease in the medication's efficacy, contact your doctor. Do not exceed the prescribed dose, as this may increase the risk of adverse effects.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in pediatric populations.
This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
If you are breast-feeding or plan to breast-feed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Lack of coordination
- Lethargy
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Flumazenil may be used as an antidote in severe cases, but it carries risks, especially in patients with benzodiazepine dependence or seizure disorders.
Drug Interactions
Contraindicated Interactions
- Opioid analgesics (concomitant use significantly increases risk of respiratory depression, profound sedation, coma, and death)
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics) - relative contraindication due to additive CNS depression
Major Interactions
- Alcohol
- Barbiturates (e.g., phenobarbital)
- Other benzodiazepines
- Antipsychotics (e.g., clozapine, olanzapine)
- Antidepressants (e.g., tricyclic antidepressants, mirtazapine)
- Antihistamines (e.g., diphenhydramine)
- Muscle relaxants (e.g., baclofen, carisoprodol)
- Narcotic analgesics (e.g., morphine, oxycodone)
- Sedative-hypnotics (e.g., zolpidem)
- Valproic acid (increases lorazepam levels)
- Probenecid (increases lorazepam levels)
Moderate Interactions
- Oral contraceptives (may increase lorazepam clearance)
- Theophylline/Aminophylline (may decrease benzodiazepine effects)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Mental status (orientation, alertness)
Rationale: To assess baseline neurological function and identify pre-existing cognitive impairment.
Timing: Prior to initiation of therapy.
Vital signs (blood pressure, heart rate, respiratory rate)
Rationale: To establish baseline cardiovascular and respiratory status, especially important before IV administration.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: Although not extensively metabolized by CYP450, severe hepatic impairment can affect clearance.
Timing: Prior to initiation in patients with known or suspected hepatic impairment.
Renal function tests (BUN, creatinine)
Rationale: To assess baseline renal function, though dose adjustment is usually not required for mild-moderate impairment.
Timing: Prior to initiation in patients with known or suspected renal impairment.
Routine Monitoring
Sedation level/Alertness
Frequency: Daily or as needed, especially during dose titration or initiation.
Target: Desired therapeutic effect without excessive sedation.
Action Threshold: Excessive drowsiness, lethargy, or unresponsiveness; consider dose reduction or discontinuation.
Respiratory rate and depth
Frequency: Regularly, especially with higher doses or concomitant CNS depressants.
Target: Normal respiratory rate (12-20 breaths/min) and adequate depth.
Action Threshold: Respiratory depression (<10 breaths/min, shallow breathing); requires immediate intervention.
Anxiety/Insomnia symptom control
Frequency: Regularly, based on clinical need.
Target: Reduction in target symptoms.
Action Threshold: Lack of efficacy after adequate trial; consider alternative therapy or dose adjustment.
Signs of dependence/withdrawal
Frequency: Periodically, especially with long-term use or during dose reduction.
Target: Absence of withdrawal symptoms (e.g., rebound anxiety, seizures, tremors).
Action Threshold: Emergence of withdrawal symptoms; requires slow tapering.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Ataxia (impaired coordination)
- Confusion
- Slurred speech
- Respiratory depression
- Paradoxical reactions (e.g., agitation, aggression, hallucinations, especially in children or elderly)
- Memory impairment (anterograde amnesia)
- Signs of withdrawal upon discontinuation (e.g., rebound anxiety, insomnia, tremors, seizures, muscle cramps, vomiting)
Special Patient Groups
Pregnancy
Category D. Lorazepam can cause fetal harm when administered to a pregnant woman. There is evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g., in life-threatening situations or for a serious disease for which safer drugs cannot be used or are ineffective).
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting.
Second Trimester:
Risk of fetal adverse effects (e.g., respiratory depression, hypotonia, feeding difficulties) if used close to delivery.
Third Trimester:
Risk of 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) and withdrawal symptoms (e.g., hypertonia, irritability, tremors, feeding difficulties) in neonates exposed late in pregnancy.
Lactation
L3 (Moderately Safe). Lorazepam is excreted into breast milk. While generally considered compatible with breastfeeding with caution, monitor the infant for sedation, poor feeding, and weight gain. Long-term use or high doses may be more concerning.
Infant Risk:
Sedation, lethargy, poor feeding, and weight loss in the infant. Risk is higher with higher maternal doses or in premature/neonatal infants.
Pediatric Use
Use with caution. Children, especially younger ones, may be more sensitive to the CNS depressant effects and may experience paradoxical reactions (e.g., hyperactivity, agitation). IV lorazepam contains propylene glycol, which can cause toxicity (e.g., metabolic acidosis, renal dysfunction) in neonates and young children, especially with high doses or prolonged infusions.
Geriatric Use
Elderly patients are more sensitive to the CNS depressant effects of benzodiazepines and are at increased risk of falls, cognitive impairment, and paradoxical reactions. Lower initial doses (e.g., 0.5-1 mg) are recommended, and titration should be slow. Monitor closely for sedation, dizziness, and cognitive changes.
Clinical Information
Clinical Pearls
- Lorazepam has a relatively short half-life compared to some other benzodiazepines, making it useful for acute anxiety or insomnia, but also increasing the risk of rebound anxiety and withdrawal symptoms upon abrupt discontinuation.
- It is metabolized primarily by glucuronidation, which is less affected by age or liver disease than oxidative metabolism, making it a preferred benzodiazepine in patients with hepatic impairment or in the elderly, though dose adjustments are still necessary in severe cases.
- Tolerance and physical dependence can develop with chronic use. Tapering the dose slowly over weeks to months is crucial to prevent severe withdrawal symptoms.
- Paradoxical reactions (e.g., agitation, aggression, disinhibition) can occur, particularly in children, elderly, or patients with psychiatric disorders.
- IV lorazepam is a first-line treatment for status epilepticus due to its rapid onset of action.
Alternative Therapies
- Other benzodiazepines (e.g., alprazolam, diazepam, clonazepam for anxiety; temazepam, zolpidem for insomnia)
- SSRIs/SNRIs (for anxiety disorders, long-term management)
- Buspirone (for generalized anxiety disorder, non-sedating)
- Hydroxyzine (antihistamine with anxiolytic/sedative properties)
- Beta-blockers (e.g., propranolol for performance anxiety)
- Non-pharmacological therapies (e.g., cognitive behavioral therapy, mindfulness, exercise)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (0.5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.