Lorazepam 4mg/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 the brain and nerves. It belongs to a group of drugs called benzodiazepines. It works by slowing down brain activity, which helps to treat severe anxiety, stop seizures (like in epilepsy), or make you sleepy before medical procedures. Because it can cause strong sedation, it's usually given in a hospital or clinic setting.
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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 be sure to follow all instructions provided. This medication 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 procedure.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (e.g., opioids, sleeping pills) unless specifically instructed by your doctor, as this can dangerously increase drowsiness and breathing problems.
  • Do not drive or operate heavy machinery after receiving lorazepam, as it can impair your ability to perform these tasks safely.
  • Inform your healthcare provider about all medications you are taking, including over-the-counter drugs, herbal supplements, and recreational drugs.
  • If you are receiving this medication regularly, do not stop it suddenly without consulting your doctor, as this can lead to withdrawal symptoms.

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: 0.02 - 4 mg

Condition-Specific Dosing:

statusEpilepticus: 4 mg IV over 2-5 minutes, may repeat once after 10-15 minutes (max 8 mg/24h)
anxiety: 2-4 mg IM/IV
premedication: 0.05 mg/kg (up to 4 mg) IM 2 hours prior to surgery, or IV 15-20 minutes prior to surgery
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Pediatric Dosing

Neonatal: Not established for routine use; caution advised. For status epilepticus (off-label): 0.05 mg/kg IV over 2-5 minutes, may repeat once.
Infant: For status epilepticus: 0.05-0.1 mg/kg IV over 2-5 minutes (max 4 mg/dose), may repeat once after 10-15 minutes if needed.
Child: For status epilepticus: 0.05-0.1 mg/kg IV over 2-5 minutes (max 4 mg/dose), may repeat once after 10-15 minutes if needed. For anxiety/sedation: 0.05 mg/kg IM/IV (max 2 mg/dose).
Adolescent: For status epilepticus: 0.05-0.1 mg/kg IV over 2-5 minutes (max 4 mg/dose), may repeat once after 10-15 minutes if needed. For anxiety/sedation: 0.05 mg/kg IM/IV (max 4 mg/dose).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required, but monitor for increased sedation.
Severe: No specific adjustment typically required, but monitor for increased sedation due to accumulation of inactive glucuronide metabolite.
Dialysis: Not significantly dialyzable. No specific supplemental dose needed, but monitor closely.

Hepatic Impairment:

Mild: Consider lower initial doses and careful titration.
Moderate: Consider lower initial doses (e.g., 50% reduction) and careful titration due to prolonged half-life.
Severe: Significant dose reduction (e.g., 50% or more) and close monitoring are recommended due to impaired metabolism and prolonged half-life.

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 by increasing the frequency of chloride channel opening, leading to neuronal hyperpolarization and reduced neuronal excitability. This results in anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM)
Tmax: IV: Rapid (minutes); IM: 30-60 minutes
FoodEffect: Not applicable for injection.

Distribution:

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

Elimination:

HalfLife: Approximately 10-20 hours (parent drug)
Clearance: Approximately 0.9 mL/min/kg
ExcretionRoute: Renal (primarily 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 (sedation/anxiolysis); up to 24 hours (anticonvulsant effect can be longer)

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. The use of benzodiazepines, including lorazepam, exposes patients to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing lorazepam, assess each patient's risk for abuse, misuse, and addiction. Prolonged use of benzodiazepines, including lorazepam, may lead to physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher doses. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage.
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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 may 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 or seek medical attention:

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
  • Confusion or disorientation
  • Unusual weakness
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty 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 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 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-Administration Precautions

Avoid operating a vehicle or 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 administration, 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 contain benzyl alcohol, which can cause serious side effects in newborns and infants. If possible, avoid using products with benzyl alcohol in these age groups, especially 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 impair 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 exceed the prescribed duration of treatment or take this medication for longer than recommended by your doctor.
Prolonged use or high doses may lead to tolerance, reducing the medication's effectiveness. If you experience decreased efficacy, contact your doctor. Do not increase your dose without medical supervision.

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, exercise caution, as the risk of certain side effects may be higher in this age group.

Pregnancy and Breastfeeding

This medication may harm the unborn baby if taken during pregnancy. If you become pregnant or are already pregnant, 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 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:

  • Profound sedation
  • Somnolence
  • Confusion
  • Impaired coordination (ataxia)
  • Diminished reflexes
  • Hypotension
  • Respiratory depression
  • 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, morphine): 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 depressant effects.
  • Valproate: May increase lorazepam plasma concentrations and enhance its effects due to inhibition of glucuronidation.
  • Probenecid: May increase lorazepam plasma concentrations and prolong its half-life due to inhibition of glucuronidation.
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Moderate Interactions

  • Clozapine: Increased risk of sedation, hypotension, and respiratory depression.
  • Scopolamine: Increased incidence of sedation, hallucinations, and disoriention.
  • Theophylline/Aminophylline: May antagonize the sedative effects of lorazepam.

Monitoring

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Baseline Monitoring

Vital Signs (HR, BP, RR, SpO2)

Rationale: To establish baseline physiological status and identify pre-existing abnormalities.

Timing: Prior to administration

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

Rationale: To assess baseline neurological status and guide initial dosing.

Timing: Prior to administration

Respiratory Status (rate, depth, effort)

Rationale: To assess baseline respiratory function, especially important due to risk of respiratory depression.

Timing: Prior to administration

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Routine Monitoring

Vital Signs (HR, BP, RR, SpO2)

Frequency: Every 5-15 minutes during acute administration (e.g., status epilepticus), then every 1-4 hours or as clinically indicated.

Target: Within patient's normal range; SpO2 >92%

Action Threshold: Significant drop in BP, HR <50 bpm, RR <10 bpm, SpO2 <90%

Level of Consciousness/Sedation Score

Frequency: Every 15-30 minutes during acute administration, then every 1-4 hours or as clinically indicated.

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.

Respiratory Status

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

Target: Normal respiratory rate and effort

Action Threshold: Bradypnea, hypoventilation, apnea, or signs of respiratory distress.

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Hypotension
  • Bradycardia
  • Paradoxical excitation (agitation, aggression)
  • Ataxia, dizziness
  • Slurred speech
  • Signs of allergic reaction (rash, itching, swelling)

Special Patient Groups

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Pregnancy

Lorazepam is classified as Pregnancy Category D, indicating positive evidence of human fetal risk. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

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. Avoidance is generally recommended.
Second Trimester: Less data available, but continued exposure may lead to fetal benzodiazepine syndrome.
Third Trimester: Use during the third trimester or near term may result in 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression, feeding difficulties) and neonatal withdrawal symptoms (irritability, hypertonia, tremor, diarrhea, vomiting, seizures) after birth.
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Lactation

Lorazepam is excreted into breast milk. The American Academy of Pediatrics considers it to be a drug for which the effect on the nursing infant is unknown but may be of concern. Lactation risk is L3 (Moderately Safe).

Infant Risk: Potential for sedation, poor feeding, and weight gain in the infant. Monitor infants for drowsiness, feeding difficulties, and developmental milestones. Consider using the lowest effective dose for the shortest duration possible, or choosing an alternative drug with less excretion into milk or a shorter half-life. If used, administer immediately after feeding to minimize infant exposure.
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Pediatric Use

Use in pediatric patients, especially neonates and infants, requires extreme caution due to increased sensitivity to CNS depressant effects and potential for respiratory depression. Dosing must be carefully calculated based on weight. Prolonged use can lead to physical dependence and withdrawal symptoms upon discontinuation.

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Geriatric Use

Elderly patients are more sensitive to the sedative and CNS depressant effects of lorazepam, including increased risk of falls, cognitive impairment, and respiratory depression. Lower initial doses (e.g., 50% of adult dose) and slower titration are recommended. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • For IV administration, lorazepam injection must be diluted with an equal volume of compatible diluent (e.g., Sterile Water for Injection, Normal Saline, D5W) immediately prior to use. Do not dilute with other solutions.
  • Administer IV lorazepam slowly (no faster than 2 mg/minute) to minimize the risk of respiratory depression, hypotension, and apnea.
  • Rapid IV injection can cause apnea, hypotension, bradycardia, or cardiac arrest.
  • IM administration should be deep into a large muscle mass.
  • Lorazepam injection contains polyethylene glycol and propylene glycol as excipients. High doses or prolonged infusions, especially in patients with renal impairment, can lead to propylene glycol toxicity (e.g., metabolic acidosis, renal dysfunction, CNS toxicity).
  • Always have resuscitation equipment (e.g., oxygen, bag-valve-mask, intubation supplies) and flumazenil readily available when administering IV lorazepam.
  • Tolerance and physical dependence can develop with prolonged use. Tapering is essential upon discontinuation to prevent withdrawal symptoms.
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Alternative Therapies

  • Diazepam (for status epilepticus, anxiety, sedation)
  • Midazolam (for sedation, status epilepticus)
  • Phenobarbital (for status epilepticus, refractory seizures)
  • Fosphenytoin/Phenytoin (for status epilepticus)
  • Propofol (for sedation in ICU)
  • Dexmedetomidine (for sedation in ICU)
  • Buspirone (for anxiety, non-benzodiazepine)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and quantity per 10ml vial (4mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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, 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 quantity, and the time of ingestion.