Lorazepam 2mg Tablets

Manufacturer LEADING PHARMA Active Ingredient Lorazepam Tablets(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 is a medication that belongs to a class of drugs called benzodiazepines. It works by calming the brain and nerves, which helps to reduce anxiety, promote sleep, and control seizures. It's often used for short-term treatment of anxiety or insomnia, or to stop seizures.
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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. You can take this medication with or without food, but if it causes stomach upset, take it with food.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication by throwing it away, but do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid alcohol and other central nervous system depressants (e.g., opioids, sleeping pills, cold/allergy medicines that cause drowsiness) as this can increase the risk of severe drowsiness, breathing problems, coma, and death.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and impaired coordination.
  • Do not stop taking this medication suddenly, especially if you have been taking it regularly for a long time, as this can lead to withdrawal symptoms (e.g., seizures, tremors, severe anxiety). Your doctor will guide you on how to slowly reduce the dose.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and recreational drugs.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 2-3 mg/day in 2-3 divided doses. Insomnia: 2-4 mg at bedtime. Status Epilepticus: 4 mg IV over 2-5 minutes, repeat once if needed after 10-15 minutes.
Dose Range: 0.5 - 10 mg

Condition-Specific Dosing:

Anxiety: Initial: 1-2 mg/day in 2-3 divided doses; usual: 2-6 mg/day. Max: 10 mg/day.
Insomnia: 2-4 mg at bedtime.
Premedication: 0.05 mg/kg (max 4 mg) IM 2 hours pre-op, or 0.044 mg/kg (max 2 mg) IV 15-20 minutes pre-op.
Status Epilepticus: 4 mg IV over 2-5 minutes; may repeat once after 10-15 minutes if seizures persist. Max single dose 4 mg.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to risk of propylene glycol toxicity with IV formulation).
Infant: Not established (use with extreme caution due to risk of propylene glycol toxicity with IV formulation).
Child: Status Epilepticus (IV): 0.05-0.1 mg/kg (max 4 mg/dose) over 2-5 minutes; may repeat after 10-15 minutes. Anxiety/Insomnia (Oral): Not routinely recommended; if used, lower doses than adults.
Adolescent: Status Epilepticus (IV): 0.05-0.1 mg/kg (max 4 mg/dose) over 2-5 minutes; may repeat after 10-15 minutes. Anxiety/Insomnia (Oral): Similar to adult dosing, but start with lowest effective dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased sedation.
Severe: Use with caution; consider lower doses and monitor closely for increased sedation due to accumulation of glucuronide metabolite.
Dialysis: Lorazepam is not significantly dialyzable. No specific supplemental dose needed, but monitor for increased sedation.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution; consider lower initial doses (e.g., 50% of usual dose) and titrate slowly.
Severe: Significant dose reduction required (e.g., 50% or more of usual dose); monitor closely for excessive sedation and encephalopathy. Lorazepam is preferred over other benzodiazepines that undergo oxidative metabolism.

Pharmacology

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Mechanism of Action

Lorazepam is a benzodiazepine that 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, leading to increased chloride ion influx into neurons, hyperpolarization, and decreased neuronal excitability. This results in anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90% (oral)
Tmax: Oral: 2 hours; Intramuscular: 1.5 hours; Intravenous: 10-20 minutes (peak CNS effect)
FoodEffect: Food may delay the rate of absorption (Tmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 1.3 L/kg
ProteinBinding: Approximately 85%
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 10-20 hours (parent drug)
Clearance: Approximately 0.9 mL/min/kg
ExcretionRoute: Primarily renal (as inactive glucuronide conjugate)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Oral: 20-30 minutes; Intravenous: 1-5 minutes
PeakEffect: Oral: 2 hours; Intravenous: 10-20 minutes
DurationOfAction: 6-8 hours (sedative effects); anxiolytic effects may persist 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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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 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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness
Drowsiness
Fatigue
Weakness
* Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 sedation
  • Difficulty breathing or shallow breathing
  • Unusual dizziness or lightheadedness
  • Severe confusion or memory problems
  • Slurred speech
  • Unsteadiness or difficulty walking (ataxia)
  • Paradoxical reactions such as increased agitation, aggression, hallucinations, or excitement
  • Yellowing of the skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., 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 and its symptoms.
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 dosage of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Additionally, avoid consuming alcohol while taking this medication, as it may exacerbate its effects.

Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) drugs that may cause drowsiness or slow your reactions, consult with your doctor. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

Adhere to your doctor's prescribed dosage and duration of treatment. Do not take this medication for an extended period beyond what your doctor has recommended. Prolonged use or high doses may lead to tolerance, reducing the drug's effectiveness. If you experience decreased efficacy, contact your doctor. Do not exceed the prescribed dose, as this may increase the risk of adverse effects.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in pediatric populations.

This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are already pregnant, notify your doctor immediately. Taking this medication late in pregnancy may increase the risk of respiratory or feeding problems, hypothermia, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.

If you are breast-feeding or plan to breast-feed, inform your doctor, as this medication can pass into breast milk and potentially harm your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Flumazenil may be used as an antidote in severe cases, but it carries risks, especially in patients with chronic benzodiazepine use or seizure disorders.

Drug Interactions

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Major Interactions

  • Opioids (increased risk of profound sedation, respiratory depression, coma, and death)
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics, skeletal muscle relaxants) - increased risk of additive CNS depression.
  • Valproate (increases lorazepam plasma concentrations and effects by inhibiting glucuronidation)
  • Probenecid (increases lorazepam plasma concentrations and effects by inhibiting glucuronidation)
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Moderate Interactions

  • Scopolamine (increased incidence of sedation, hallucinations, and irrational behavior)
  • Theophylline/Aminophylline (may antagonize sedative effects of lorazepam)
  • Loxapine (may cause stupor, respiratory distress, and hypotension)
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Minor Interactions

  • Oral contraceptives (may slightly increase lorazepam clearance, but generally not clinically significant)

Monitoring

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Baseline Monitoring

Mental status and level of consciousness

Rationale: To establish baseline and assess for excessive sedation or paradoxical reactions.

Timing: Prior to initiation and periodically during therapy.

Respiratory rate and oxygen saturation

Rationale: To assess for respiratory depression, especially with IV administration or concomitant CNS depressants.

Timing: Prior to initiation, during IV administration, and periodically during therapy.

Blood pressure and heart rate

Rationale: To monitor for hypotension or bradycardia, particularly with IV administration.

Timing: Prior to initiation and periodically during therapy.

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Routine Monitoring

Efficacy (e.g., anxiety level, sleep quality, seizure control)

Frequency: Daily or as clinically indicated

Target: Improvement in target symptoms without excessive sedation.

Action Threshold: Lack of efficacy or excessive sedation warrants dose adjustment or re-evaluation.

Adverse effects (e.g., sedation, dizziness, ataxia, cognitive impairment)

Frequency: Daily or as clinically indicated

Target: Minimal to no adverse effects.

Action Threshold: Persistent or severe adverse effects warrant dose reduction or discontinuation.

Signs of tolerance, dependence, or withdrawal

Frequency: Periodically, especially with long-term use

Target: Absence of these signs.

Action Threshold: Development of tolerance or dependence requires re-evaluation of therapy; withdrawal symptoms upon discontinuation indicate physical dependence.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Ataxia (impaired coordination)
  • Slurred speech
  • Confusion
  • Memory impairment
  • Respiratory depression (slow, shallow breathing)
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations, increased anxiety)
  • Signs of withdrawal upon discontinuation (e.g., rebound anxiety, insomnia, tremors, seizures)

Special Patient Groups

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Pregnancy

Category D. Lorazepam can cause fetal harm when administered to a pregnant woman. There is evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g., in life-threatening situations or for a serious disease for which safer drugs cannot be used or are ineffective). Neonatal flaccidity, respiratory and feeding difficulties, and hypothermia have been reported in infants born to mothers who have received benzodiazepines late in pregnancy.

Trimester-Specific Risks:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) has been suggested in some studies, though data are conflicting.
Second Trimester: Risk of adverse effects on fetal development is less clear, but continued exposure may lead to neonatal withdrawal symptoms.
Third Trimester: Risk of neonatal withdrawal syndrome (e.g., irritability, hypertonia, tremors, feeding difficulties) and 'floppy infant syndrome' (hypotonia, lethargy, respiratory depression) if used close to delivery.
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Lactation

L3 (Moderate risk). Lorazepam is excreted into breast milk. Due to its long half-life and potential for accumulation, it can cause sedation, poor feeding, and weight loss in breastfed infants. Use with caution; monitor infant for sedation and feeding difficulties. Consider alternatives or use the lowest effective dose for the shortest duration.

Infant Risk: Sedation, lethargy, poor feeding, weight loss, respiratory depression.
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Pediatric Use

Use in pediatric patients is generally limited due to lack of established safety and efficacy, especially for anxiety/insomnia. IV lorazepam is used for status epilepticus in children. Oral use for anxiety is off-label and should be done with extreme caution, starting with very low doses and close monitoring. IV formulation contains propylene glycol and polyethylene glycol, which can cause toxicity (e.g., metabolic acidosis, renal dysfunction) in neonates and young children, especially with high doses or prolonged infusions.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and are at increased risk for adverse effects such as sedation, dizziness, ataxia, falls, and cognitive impairment. Start with the lowest effective dose (e.g., 0.5 mg) and titrate slowly. Monitor closely for CNS depression and falls. Avoid long-term use if possible.

Clinical Information

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Clinical Pearls

  • Lorazepam is often preferred in patients with liver impairment compared to other benzodiazepines because it undergoes direct glucuronidation, which is less affected by liver disease than oxidative metabolism.
  • IV lorazepam is a first-line treatment for status epilepticus due to its rapid onset of action.
  • Due to the risk of dependence and withdrawal, lorazepam should generally be used for short-term treatment (2-4 weeks) of anxiety or insomnia. Tapering is essential upon discontinuation after prolonged use.
  • The IV formulation contains propylene glycol, which can accumulate and cause toxicity (e.g., metabolic acidosis, acute kidney injury) with high doses or prolonged infusions, especially in patients with renal impairment or in neonates/children.
  • Paradoxical reactions (e.g., agitation, aggression, disinhibition) can occur, particularly in pediatric, elderly, or psychiatric patients.
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Alternative Therapies

  • Other benzodiazepines (e.g., alprazolam, clonazepam, diazepam, oxazepam)
  • SSRIs (e.g., escitalopram, sertraline) for long-term anxiety management
  • SNRIs (e.g., venlafaxine, duloxetine) for long-term anxiety management
  • Buspirone (for anxiety, non-sedating)
  • Hydroxyzine (for anxiety, sedating antihistamine)
  • Z-drugs (e.g., zolpidem, eszopiclone) for insomnia
  • Antidepressants (e.g., trazodone, mirtazapine) for insomnia
  • Non-pharmacological therapies (e.g., cognitive behavioral therapy for anxiety/insomnia, relaxation techniques, lifestyle modifications)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (2mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.