Lorazepam 2mg/ml Inj, 1ml

Manufacturer HOSPIRA Active Ingredient Lorazepam Injection Solution(lor A ze pam) Pronunciation lor-A-ze-pam
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.
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Drug Class
Anxiolytic, Sedative-Hypnotic, Anticonvulsant
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category D
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FDA Approved
May 1977
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Lorazepam injection is a medicine given by a doctor or nurse, usually into a vein or muscle, to help calm you down, reduce anxiety, or stop seizures. It works by affecting certain chemicals in your brain to slow down overactivity.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and follow all instructions provided. This drug is administered via injection into a muscle or vein.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid alcohol completely while receiving this medication, as it can dangerously increase drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medication affects you and you are no longer feeling drowsy or dizzy.
  • Do not take other sedatives, sleeping pills, or pain medications (especially opioids) without discussing with your doctor, as this can lead to dangerous side effects.
  • Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and route (IM/IV)

Condition-Specific Dosing:

Anxiety (IM): 2-4 mg, repeat every 6-8 hours as needed
Insomnia (IM): 2-4 mg at bedtime
Premedication (IM): 0.05 mg/kg (up to 4 mg) 2 hours prior to surgery
Premedication (IV): 0.044 mg/kg (up to 2 mg) 15-20 minutes prior to surgery
Status Epilepticus (IV): 4 mg slow IV push (2 mg/min), may repeat once after 10-15 minutes if seizures persist (max 8 mg/24 hours)
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, risk of propylene glycol toxicity)
Infant: Not established (use with extreme caution, risk of propylene glycol toxicity)
Child: Status Epilepticus (IV): 0.05-0.1 mg/kg (max 4 mg/dose) slow IV push, may repeat once after 10-15 minutes. Premedication (IM/IV): 0.05 mg/kg (max 2 mg) 15-20 minutes prior to procedure.
Adolescent: Status Epilepticus (IV): 0.05-0.1 mg/kg (max 4 mg/dose) slow IV push, may repeat once after 10-15 minutes. Premedication (IM/IV): 0.05 mg/kg (max 2 mg) 15-20 minutes prior to procedure.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed, monitor for increased sedation
Severe: Use with caution, consider lower initial doses and monitor closely for increased sedation
Dialysis: Not significantly dialyzable; use with caution, monitor for increased sedation

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: Use with caution, consider lower initial doses and monitor closely for increased sedation
Severe: Use with caution, consider lower initial doses and monitor closely for increased sedation

Pharmacology

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Mechanism of Action

Lorazepam, a benzodiazepine, binds to specific benzodiazepine receptors on the gamma-aminobutyric acid (GABA)-A receptor complex in the central nervous system. This binding enhances the inhibitory effects of GABA, the primary inhibitory neurotransmitter in the brain, by increasing the frequency of chloride channel opening. This leads to neuronal hyperpolarization, decreased neuronal excitability, and ultimately, anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects.
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Pharmacokinetics

Absorption:

Bioavailability: IM: Approximately 90%
Tmax: IM: 60-90 minutes; IV: Immediate onset of action, peak plasma levels not applicable in the same way as oral/IM
FoodEffect: Not applicable for injection

Distribution:

Vd: Approximately 1.3 L/kg
ProteinBinding: Approximately 85%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 10-20 hours
Clearance: Approximately 0.9-1.3 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugate)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: IV: 1-5 minutes; IM: 15-30 minutes
PeakEffect: IV: 5-10 minutes; IM: 60-90 minutes
DurationOfAction: 6-8 hours (sedation), anxiolytic effects may last up to 24 hours

Safety & Warnings

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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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although 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 medical attention immediately:

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 contact your doctor or seek medical help if you're bothered by any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Headache
Irritation at the injection site

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.
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Seek Immediate Medical Attention If You Experience:

  • Extreme drowsiness or difficulty waking up
  • Very slow or shallow breathing
  • Bluish lips or skin
  • Severe dizziness or lightheadedness
  • Unusual confusion or disorientation
  • Paradoxical reactions such as agitation, aggression, or hallucinations (rare but possible)
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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 symptoms you experienced.
Certain health conditions, including:
+ Glaucoma
+ Depression or specific mental health issues
+ Sleep apnea or breathing problems
+ 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 the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

Post-Treatment Precautions

Avoid driving and engaging in activities that require alertness for 1 to 2 full days after receiving this medication, or until its effects have worn off.
For at least 8 hours after using this medication, do not attempt to get out of bed without assistance, as you may be at risk of falling and injuring yourself.
Refrain from consuming alcohol for 1 to 2 full days after receiving this medication.

Special Considerations

Some products containing this medication may include benzyl alcohol. If possible, avoid using these products in newborns or infants, as benzyl alcohol can cause serious side effects in these children, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
Before using marijuana, cannabis, or prescription or over-the-counter medications that may slow your reactions, discuss the potential risks with your doctor.

Long-Term Use and Monitoring

If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition.
Do not take this medication for longer than prescribed by your doctor.
Prolonged use or high doses of this medication can lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.

Age-Related Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.

Pregnancy and Breastfeeding

This medication may harm the unborn baby if taken during pregnancy. If you become pregnant or are pregnant while taking this medication, notify your doctor immediately.
Taking this medication late in pregnancy may increase the risk of breathing or feeding problems, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
If you are breastfeeding or plan to breastfeed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.

Procedure-Related Risks

Studies have shown that frequent or long-term use of anesthesia or sleep medications in children under 3 years old may lead to long-term brain problems. This risk may also apply to unborn babies if the mother uses this medication during the third trimester of pregnancy. Consult your doctor to discuss the potential risks and benefits.
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Overdose Information

Overdose Symptoms:

  • Somnolence (extreme drowsiness)
  • Confusion
  • Lethargy
  • Hypotension (low blood pressure)
  • Ataxia (loss of coordination)
  • Hypoventilation (slow or shallow breathing)
  • Coma
  • Death

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including maintaining a patent airway, assisting ventilation, and monitoring vital signs. Flumazenil, a benzodiazepine receptor antagonist, may be used to reverse the effects but carries risks, especially in patients with chronic benzodiazepine use or seizure disorders.

Drug Interactions

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Major Interactions

  • Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for patients for whom alternative treatment options are inadequate.
  • Alcohol: Potentiation of CNS depressant effects, leading to severe sedation, respiratory depression, and hypotension.
  • Other CNS depressants (e.g., barbiturates, other benzodiazepines, tricyclic antidepressants, antipsychotics, antihistamines, general anesthetics): Additive CNS depressant effects.
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Moderate Interactions

  • Valproic acid: May inhibit lorazepam glucuronidation, leading to increased lorazepam plasma concentrations and enhanced CNS depression. Consider a 50% reduction in lorazepam dose.
  • Probenecid: May inhibit lorazepam glucuronidation, leading to increased lorazepam plasma concentrations and enhanced CNS depression. Consider a 50% reduction in lorazepam dose.
  • Scopolamine: Increased incidence of sedation, hallucinations, and disoriented behavior.
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Minor Interactions

  • Theophylline/Aminophylline: May antagonize the sedative effects of lorazepam.

Monitoring

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Baseline Monitoring

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression, especially with IV administration.

Timing: Prior to administration

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status and monitor for hypotension or bradycardia.

Timing: Prior to administration

Level of consciousness/Sedation score (e.g., Ramsay Sedation Scale)

Rationale: To establish baseline mental status and guide dosing.

Timing: Prior to administration

Oxygen saturation (SpO2)

Rationale: To assess baseline oxygenation, especially in patients with respiratory compromise.

Timing: Prior to administration

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Routine Monitoring

Respiratory rate and depth

Frequency: Every 5-15 minutes during IV administration and for 1-2 hours post-administration, then as clinically indicated.

Target: Maintain within patient's normal range, avoid significant depression.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of respiratory distress; administer oxygen, consider flumazenil if severe.

Blood pressure and heart rate

Frequency: Every 5-15 minutes during IV administration and for 1-2 hours post-administration, then as clinically indicated.

Target: Maintain within patient's normal range, avoid significant hypotension.

Action Threshold: Systolic BP <90 mmHg or significant drop from baseline; administer fluids, consider vasopressors if severe.

Level of consciousness/Sedation score

Frequency: Continuously during acute administration, then every 1-4 hours or as clinically indicated.

Target: Desired level of sedation (e.g., drowsy but arousable for anxiety, deeply sedated for procedures).

Action Threshold: Excessive sedation (unarousable), paradoxical excitation; reduce dose, consider flumazenil if severe.

Oxygen saturation (SpO2)

Frequency: Continuous pulse oximetry during IV administration and for 1-2 hours post-administration, then as clinically indicated.

Target: >92-94%

Action Threshold: <90% or significant drop from baseline; administer oxygen, consider airway support.

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Hypotension
  • Bradycardia
  • Paradoxical reactions (agitation, aggression, hallucinations)
  • Ataxia or uncoordination
  • Slurred speech
  • Dizziness

Special Patient Groups

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Pregnancy

Lorazepam is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Benzodiazepines can cross the placenta and may cause fetal harm.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested by some studies, though data are conflicting and not definitively established for all benzodiazepines.
Second Trimester: Risk of fetal exposure and potential for withdrawal symptoms in the neonate if used chronically.
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties, hypothermia, respiratory depression) if administered shortly before or during labor. Neonatal withdrawal symptoms (e.g., hypertonia, tremor, irritability, feeding difficulties, vomiting, diarrhea, seizures) may occur if used chronically during late pregnancy.
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Lactation

Lorazepam is excreted into breast milk. The American Academy of Pediatrics considers it to have an unknown effect on the nursing infant but may be of concern. The risk-benefit should be carefully weighed. Monitor the infant for sedation, poor feeding, and weight gain.

Infant Risk: L3 (Moderately safe - There are no controlled studies in breastfeeding women, but the risk of adverse effects to the infant is possible. Use only if the potential benefit justifies the potential risk to the infant.)
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Pediatric Use

Use with extreme caution, especially in neonates and infants, due to the risk of propylene glycol toxicity (a solvent in the injection formulation) and potential for paradoxical reactions (e.g., hyperactivity, agitation). Dosing must be carefully calculated based on weight. Long-term safety and efficacy in pediatric patients are not well-established.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may experience increased sedation, dizziness, ataxia, and an increased risk of falls. Lower initial doses (e.g., 0.5-1 mg) are recommended, and patients should be closely monitored. Renal and hepatic impairment, which are more common in the elderly, can further affect drug clearance.

Clinical Information

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Clinical Pearls

  • For IV administration, lorazepam injection should be diluted with an equal volume of compatible diluent (e.g., Sterile Water for Injection, Normal Saline, Dextrose 5% in Water) immediately before use. Administer slowly (no faster than 2 mg/min) to minimize the risk of respiratory depression and hypotension.
  • Ensure resuscitation equipment and personnel are readily available when administering IV lorazepam, especially for acute indications like status epilepticus.
  • Lorazepam injection contains propylene glycol and polyethylene glycol, which can cause toxicity (e.g., metabolic acidosis, renal dysfunction, CNS depression) with high doses or prolonged infusions, particularly in patients with renal impairment or in neonates/infants.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric or elderly patients, or those with underlying psychiatric conditions.
  • Abrupt discontinuation after prolonged use can lead to withdrawal symptoms (e.g., seizures, tremor, anxiety, insomnia). Tapering is necessary for chronic use.
  • Flumazenil is the antidote for benzodiazepine overdose but should be used with caution, especially in patients with a history of seizures or chronic benzodiazepine use, as it can precipitate acute withdrawal seizures.
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Alternative Therapies

  • For anxiety: Diazepam, alprazolam, oxazepam (other benzodiazepines); buspirone (non-benzodiazepine anxiolytic); SSRIs/SNRIs (for chronic anxiety).
  • For status epilepticus: Diazepam (IV/rectal), midazolam (IV/IM/buccal/intranasal), phenobarbital, fosphenytoin/phenytoin, levetiracetam.
  • For procedural sedation/premedication: Midazolam, propofol, etomidate, ketamine.
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Cost & Coverage

Average Cost: Varies widely per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will facilitate prompt and effective treatment.