Lorazepam 4mg/ml Inj 1ml

Manufacturer WEST-WARD 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
Sep 1977
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Lorazepam injection is a medicine used to calm the brain and nerves. It can help treat severe anxiety, stop seizures, or help you relax before a medical procedure. It works by slowing down brain activity.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle or vein.

Storing and Disposing of Your Medication

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

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid alcohol and other medications that cause drowsiness (e.g., opioids, sleeping pills) while receiving lorazepam, as this can lead to dangerous breathing problems or excessive sedation.
  • Do not drive or operate heavy machinery until you know how this medication affects you and you are no longer feeling drowsy or dizzy.
  • If you are receiving this medication regularly, do not stop it suddenly without consulting your doctor, as this can cause withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and route. For status epilepticus: 4 mg IV over 2-5 minutes, may repeat once after 10-15 minutes. For anxiety: 2-4 mg IM/IV, repeat q4-6h PRN. For pre-anesthesia: 0.05 mg/kg IM (max 4 mg) 2 hours prior or 0.044 mg/kg IV (max 2 mg) 15-20 minutes prior.
Dose Range: 0.5 - 8 mg

Condition-Specific Dosing:

statusEpilepticus: 4 mg IV over 2-5 min, may repeat once after 10-15 min (max 8 mg total)
anxiety: 2-4 mg IM/IV, repeat q4-6h PRN
insomnia: 2-4 mg IM/IV at bedtime
preAnesthesia: 0.05 mg/kg IM (max 4 mg) 2h prior; 0.044 mg/kg IV (max 2 mg) 15-20 min prior
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Pediatric Dosing

Neonatal: Not established for routine use; used off-label for status epilepticus (0.05-0.1 mg/kg IV)
Infant: Not established for routine use; used off-label for status epilepticus (0.05-0.1 mg/kg IV)
Child: Status Epilepticus (â‰Ĩ2 years): 0.05-0.1 mg/kg IV over 2-5 min (max 4 mg/dose), may repeat once after 10-15 min if needed.
Adolescent: Status Epilepticus: 0.05-0.1 mg/kg IV (max 4 mg/dose). Pre-anesthesia (â‰Ĩ12 years): 0.05 mg/kg IM (max 4 mg) 2 hours prior.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for increased sedation. No specific dose reduction guidelines, but consider lower end of dosing range.
Dialysis: Not significantly dialyzable; no supplemental dose needed post-dialysis. Use with caution.

Hepatic Impairment:

Mild: Initiate with lower doses (e.g., 50% of usual dose).
Moderate: Initiate with lower doses (e.g., 50% of usual dose); monitor closely for increased sedation and adverse effects.
Severe: Avoid or use with extreme caution and significant dose reduction; monitor closely for profound sedation and respiratory depression.

Pharmacology

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Mechanism of Action

Lorazepam binds allosterically 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 by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuronal membrane and decreased neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%; IM: ~90%
Tmax: IV: 1-5 minutes (onset); IM: 60-90 minutes
FoodEffect: Not applicable for injection.

Distribution:

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

Elimination:

HalfLife: 10-20 hours
Clearance: ~0.9 mL/min/kg
ExcretionRoute: Primarily renal (as glucuronide conjugate)
Unchanged: <10%
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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 (sedative effects); up to 24 hours (anxiolytic effects)

Safety & Warnings

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BLACK BOX WARNING

Concomitant use of benzodiazepines, including lorazepam, 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. Monitor 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. Before prescribing lorazepam, assess each patient's risk of abuse, misuse, and addiction. The continued use of benzodiazepines, including lorazepam, may lead to physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher doses. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening.
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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 immediately or seek emergency 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 immediately.

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
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:

  • Severe drowsiness or difficulty waking up
  • Very slow or shallow breathing
  • Bluish lips or skin
  • Confusion or unusual thoughts/behavior (paradoxical reactions)
  • Slurred speech
  • Severe dizziness or feeling like you might pass out
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 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 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 other medications and health conditions. Never start, stop, or adjust the dose 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.

Safety 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 administering this medication to children, use caution, as the risk of certain side effects may be higher in this age group.

Pregnancy and Breastfeeding

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are already pregnant, inform 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 Considerations

Research in young animals and children has 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. Discuss the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness or sedation
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Ataxia (loss of coordination)
  • Hypotension (low blood pressure)
  • Respiratory depression (slow, shallow, or stopped breathing)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management is primarily supportive, focusing on maintaining a patent airway, assisting ventilation, and supporting cardiovascular function. Flumazenil, a benzodiazepine receptor antagonist, may be used in specific cases but carries risks (e.g., precipitating seizures in dependent patients).

Drug Interactions

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Contraindicated Interactions

  • Acute narrow-angle glaucoma (relative contraindication for benzodiazepines, though less relevant for single-dose IV)
  • Severe respiratory insufficiency (without ventilatory support)
  • Sleep apnea syndrome
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Major Interactions

  • Opioids (e.g., fentanyl, morphine, oxycodone): Profound sedation, respiratory depression, coma, death.
  • Alcohol: Additive CNS depression, respiratory depression.
  • Other CNS depressants (e.g., barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics): Additive CNS depression.
  • Valproate: Increases lorazepam plasma concentrations and effects by inhibiting glucuronidation.
  • Probenecid: Increases lorazepam plasma concentrations and effects by inhibiting glucuronidation.
  • Clozapine: Increased risk of sedation, respiratory depression, hypotension, and rarely, respiratory arrest.
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Moderate Interactions

  • Theophylline/Aminophylline: May antagonize the sedative effects of lorazepam.
  • Oral Contraceptives: May slightly increase lorazepam clearance (minor clinical significance).
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Confidence Interactions

Monitoring

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Baseline Monitoring

Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate)

Rationale: To establish baseline and monitor for cardiovascular and respiratory depression.

Timing: Prior to administration

Level of Consciousness/Sedation Score (e.g., RASS, Ramsay)

Rationale: To assess baseline neurological status and guide dosing.

Timing: Prior to administration

Liver Function Tests (LFTs)

Rationale: If prolonged use or suspected hepatic impairment, as lorazepam is metabolized in the liver.

Timing: Prior to initiation of prolonged therapy

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Routine Monitoring

Respiratory Rate and Depth

Frequency: Continuously during IV administration and for several hours post-administration; frequently with IM.

Target: Normal for age (e.g., 12-20 breaths/min for adults)

Action Threshold: <10 breaths/min or signs of respiratory distress

Oxygen Saturation (SpO2)

Frequency: Continuously during IV administration and for several hours post-administration; frequently with IM.

Target: >92-94%

Action Threshold: <90% or significant drop from baseline

Blood Pressure and Heart Rate

Frequency: Every 5-15 minutes during IV administration, then periodically.

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia/tachycardia

Level of Consciousness/Sedation Score

Frequency: Every 5-15 minutes during IV administration, then periodically.

Target: Desired level of sedation

Action Threshold: Excessive sedation (e.g., unarousable) or paradoxical agitation

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Hypotension
  • Ataxia (loss of coordination)
  • Dizziness
  • Confusion
  • Paradoxical reactions (agitation, aggression, hallucinations, excitement)
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Category D. Avoid during pregnancy, especially in the first trimester due to potential increased risk of congenital malformations (e.g., cleft lip/palate). Use in the third trimester may lead to neonatal withdrawal syndrome (irritability, hypertonia, tremors, feeding difficulties) or 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression) due to placental transfer.

Trimester-Specific Risks:

First Trimester: Potential increased risk of congenital malformations (e.g., cleft lip/palate).
Second Trimester: Limited data, but generally considered less risky than first or third trimester.
Third Trimester: Risk of neonatal withdrawal syndrome, 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression).
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Lactation

L3 (Moderately Safe). Lorazepam is excreted into breast milk. Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Use the lowest effective dose for the shortest duration possible. Consider alternatives if prolonged use is necessary.

Infant Risk: Sedation, lethargy, poor feeding, poor weight gain, respiratory depression (rare).
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Pediatric Use

Use with caution. Neonates and infants are more sensitive to the CNS depressant effects. Dosing for status epilepticus is established for children â‰Ĩ2 years. Safety and efficacy for other indications in younger children are not well-established. Monitor closely for respiratory depression and paradoxical reactions.

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Geriatric Use

Increased sensitivity to CNS depressant effects (sedation, dizziness, ataxia, falls). Start with lower doses (e.g., 50% of usual adult dose) and titrate slowly. Increased risk of paradoxical reactions, cognitive impairment, and falls. Monitor closely.

Clinical Information

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Clinical Pearls

  • IV lorazepam should be administered slowly (no faster than 2 mg/minute) to minimize the risk of respiratory depression, hypotension, and excessive sedation.
  • For IV administration, lorazepam injection should be diluted with an equal volume of a compatible diluent (e.g., Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection) immediately prior to use.
  • IM administration is an option for rapid tranquilization in agitated patients when IV access is difficult, but onset is slower than IV.
  • Lorazepam is generally preferred over diazepam for patients with liver impairment due to its metabolism primarily by glucuronidation (Phase II), which is less affected by liver disease than oxidative metabolism (Phase I).
  • Not recommended for long-term daily use due to the significant risk of physical dependence and withdrawal symptoms upon discontinuation.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations, increased anxiety) can occur, especially in children, the elderly, and patients with psychiatric disorders.
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Alternative Therapies

  • For Anxiety: Diazepam, alprazolam (other benzodiazepines); buspirone; SSRIs/SNRIs (for chronic anxiety).
  • For Insomnia: Zolpidem, zaleplon, eszopiclone (Z-drugs); ramelteon; trazodone (antidepressant).
  • For Status Epilepticus: Diazepam (IV/rectal), midazolam (IV/IM/buccal/intranasal), phenobarbital, fosphenytoin/phenytoin, levetiracetam.
  • For Pre-anesthesia: Midazolam (IV/IM), diazepam (IV/oral).
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Cost & Coverage

Average Cost: Varies widely, typically $5-$20 per 4mg/ml 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.