Lorazepam 2mg/ml Inj 10ml

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
Jun 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 you down, reduce anxiety, stop seizures, or help you relax before a medical procedure. It works by affecting certain chemicals in your brain to slow down your nervous system.
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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 to you. It is essential to follow the 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 method.

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 sedating medications (e.g., pain medications, cold/allergy medicines) unless specifically approved by your doctor, as this can dangerously increase drowsiness and breathing problems.
  • 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 for anxiety or sleep, discuss non-pharmacological strategies with your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For status epilepticus: 4 mg IV over 2-5 minutes, may repeat once after 10-15 minutes if needed. For anxiety/sedation: 2-4 mg IM/IV.
Dose Range: 0.044 - 4 mg

Condition-Specific Dosing:

statusEpilepticus: 4 mg IV over 2-5 min, may repeat once after 10-15 min (max 8 mg/24h)
premedication: 0.05 mg/kg IM (max 4 mg) 2 hours pre-op; 0.044 mg/kg IV (max 2 mg) 15-20 min pre-op
anxiety: 2-4 mg IM/IV
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution if used for status epilepticus (0.05 mg/kg IV, max 2 mg)
Infant: Not established for routine use; extreme caution if used for status epilepticus (0.05 mg/kg IV, max 2 mg)
Child: Status epilepticus: 0.1 mg/kg IV (max 4 mg/dose), repeat once after 10-15 min if needed (max 8 mg/24h)
Adolescent: Status epilepticus: 0.1 mg/kg IV (max 4 mg/dose), repeat once after 10-15 min if needed (max 8 mg/24h)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed.
Moderate: No specific adjustment typically needed.
Severe: Use with caution; consider lower initial doses and monitor closely for increased sedation.
Dialysis: Not significantly dialyzable. No specific supplemental dose needed, but monitor for increased effects.

Hepatic Impairment:

Mild: No specific adjustment typically needed.
Moderate: Use with caution; consider lower initial doses and monitor closely for increased sedation.
Severe: Use with extreme caution; significantly reduced clearance. Consider lower initial doses (e.g., 50% of usual dose) and titrate slowly based on response and tolerability. Monitor for encephalopathy.

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 (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.
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Pharmacokinetics

Absorption:

Bioavailability: IM: ~90%
Tmax: IM: 60-90 minutes; IV: immediate
FoodEffect: Not applicable for injection.

Distribution:

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

Elimination:

HalfLife: 10-20 hours
Clearance: Not readily available as a single rate, but primarily hepatic metabolism.
ExcretionRoute: Renal (primarily as inactive 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), anxiolytic effects may last longer (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

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 yellowing of the 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 or seek medical help:

Dizziness
Drowsiness
Fatigue
Weakness
Headache
Irritation at the injection site

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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
  • Confusion or unusual thoughts/behavior
  • Muscle weakness or loss of coordination
  • 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 allergic reaction you experienced, including any symptoms that occurred.
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

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 change the dosage of any medication without first consulting your doctor to ensure your safety.
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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 actions, 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 an unborn baby if taken during pregnancy. If you become pregnant or are pregnant while taking this medication, notify your doctor immediately.
Using 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. Consult your doctor to discuss the potential risks and benefits.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness
  • Confusion
  • Slurred speech
  • Slowed reflexes
  • Lack of coordination
  • Hypotension (low blood pressure)
  • Respiratory depression (slow or stopped breathing)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Opioids (e.g., fentanyl, oxycodone, hydrocodone): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, general anesthetics): Additive CNS depression.
  • Sodium oxybate: Additive CNS depression.
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Moderate Interactions

  • Valproate: May increase lorazepam plasma concentrations and enhance its effects by inhibiting glucuronidation.
  • Probenecid: May increase lorazepam plasma concentrations and prolong its half-life by inhibiting glucuronidation.
  • Scopolamine: Increased incidence of sedation, hallucinations, and irrational behavior.
  • Clozapine: Increased risk of sedation, hypotension, respiratory depression, and rarely, seizures.
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Minor Interactions

  • Oral contraceptives: May slightly decrease lorazepam clearance.

Monitoring

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Baseline Monitoring

Respiratory rate, oxygen saturation

Rationale: To assess baseline respiratory function, especially before IV administration or with concomitant CNS depressants.

Timing: Prior to administration

Blood pressure, heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to administration

Level of consciousness/sedation score

Rationale: To establish baseline mental status and guide dosing.

Timing: Prior to administration

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Routine Monitoring

Respiratory rate, oxygen saturation

Frequency: Continuously or frequently (e.g., every 5-15 min) during acute IV administration and until stable; less frequently for IM.

Target: Normal for patient, SpO2 >92%

Action Threshold: Respiratory depression (<10 breaths/min), SpO2 <90%, or signs of hypoventilation; intervene with airway support/reversal agent if severe.

Blood pressure, heart rate

Frequency: Frequently during acute IV administration (e.g., every 5-15 min) and until stable.

Target: Within patient's normal limits

Action Threshold: Significant hypotension or bradycardia/tachycardia.

Level of consciousness/sedation score (e.g., RASS, Ramsay)

Frequency: Continuously or frequently during acute administration and until desired effect/recovery.

Target: Desired level of sedation (e.g., RASS -2 to 0, Ramsay 2-3)

Action Threshold: Excessive sedation (e.g., RASS -4 to -5, Ramsay 4-6) or paradoxical excitation.

Liver function tests (LFTs)

Frequency: Periodically, if used for prolonged periods or in patients with hepatic impairment.

Target: Within normal limits

Action Threshold: Significant elevation indicating liver injury.

Complete Blood Count (CBC)

Frequency: Periodically, if used for prolonged periods.

Target: Within normal limits

Action Threshold: Significant abnormalities (e.g., leukopenia, agranulocytosis).

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Hypotension
  • Paradoxical excitation (agitation, aggression)
  • Dizziness
  • Ataxia
  • Confusion
  • Memory impairment
  • Signs of withdrawal (if abruptly discontinued after prolonged use): anxiety, insomnia, irritability, tremors, seizures, hallucinations

Special Patient Groups

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Pregnancy

Category D. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Benzodiazepines can cause fetal harm, including congenital malformations (e.g., cleft lip/palate) if used during the first trimester, and neonatal flaccidity, respiratory depression, feeding difficulties (floppy infant syndrome), and withdrawal symptoms if used late in pregnancy.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate).
Second Trimester: Potential for fetal CNS depression, though less data on specific malformations.
Third Trimester: Risk of neonatal flaccidity, respiratory depression, feeding difficulties, and withdrawal symptoms (e.g., irritability, hypertonia, tremors, seizures) in the neonate.
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Lactation

Excreted into breast milk. Use with caution. Monitor breastfed infant for sedation, poor feeding, and weight gain. Consider alternative agents or temporary interruption of breastfeeding.

Infant Risk: Moderate risk (L3). Potential for sedation, lethargy, poor feeding, and weight loss in the infant. Long-term effects unknown.
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Pediatric Use

Use with caution, especially in neonates and infants, due to increased sensitivity to CNS depressant effects and potential for paradoxical reactions. Dosing for status epilepticus is weight-based and carefully titrated. Not recommended for routine anxiety or insomnia in children.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Lorazepam IV is a first-line agent for status epilepticus due to its rapid onset and relatively long duration of action compared to other short-acting benzodiazepines.
  • When administering IV, dilute with an equal volume of compatible diluent (e.g., Sterile Water for Injection, Normal Saline, D5W) and administer slowly (no faster than 2 mg/minute) to minimize local irritation and systemic adverse effects.
  • Monitor respiratory status closely, especially with IV administration or concomitant opioid use, as respiratory depression can be severe.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, particularly in pediatric and geriatric patients, or those with underlying psychiatric conditions.
  • Risk of physical dependence and withdrawal symptoms with prolonged use; taper dose gradually if discontinuing after chronic therapy.
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Alternative Therapies

  • For status epilepticus: Diazepam, Midazolam, Phenobarbital, Levetiracetam, Fosphenytoin.
  • For anxiety: Other benzodiazepines (e.g., alprazolam, clonazepam, diazepam), Buspirone, Antidepressants (SSRIs, SNRIs), Hydroxyzine.
  • For sedation/premedication: Midazolam, Propofol, Dexmedetomidine.
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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, do not share your medication with others, and never take someone else's medication. 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, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be a safe and convenient way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information about its use. 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, 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 was taken, as this will help healthcare professionals provide appropriate treatment.