Lorazepam 2mg/ml Drops 30ml

Manufacturer ROXANE Active Ingredient Lorazepam Oral 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 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, stop seizures, and help you sleep. It's often used for short periods because your body can get used to it.
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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. If it causes stomach upset, take it with food to help minimize this side effect.

To measure the correct dose, use the dropper that comes with the medication. You can mix the liquid with water, juice, soda, applesauce, or pudding to make it easier to take. Once mixed, swallow the medication right away. Do not prepare a dose and store it for later use.

Storing and Disposing of Your Medication

Store this medication in the refrigerator to keep it effective. Do not freeze the medication. Any unused portion of the medication should be discarded after 3 months. Protect the medication from light to preserve its potency. Keep the medication in a safe and secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or secure area to store your medication.

Missing a Dose

If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing 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 sedating medications (e.g., opioids, cold/allergy medicines) while taking lorazepam, as this can increase drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Do not stop taking this medication suddenly, especially if you have been taking it regularly for a while. This can cause withdrawal symptoms. Your doctor will help you slowly reduce the dose.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.
  • Store at room temperature away from light and moisture. Keep out of reach of children and pets.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 2-3 mg/day orally in 2-3 divided doses. Insomnia: 2-4 mg orally at bedtime.
Dose Range: 0.5 - 10 mg

Condition-Specific Dosing:

Anxiety: Initial: 2-3 mg/day in 2-3 divided doses. Usual range: 1-4 mg/day. Max: 10 mg/day.
Insomnia: 2-4 mg orally at bedtime.
Premedication: 2-4 mg orally 1-2 hours prior to procedure.
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Pediatric Dosing

Neonatal: Not established (use generally avoided due to risk of respiratory depression and withdrawal)
Infant: Not established (use generally avoided)
Child: Not established for oral solution; off-label use for anxiety/insomnia typically 0.02-0.05 mg/kg/dose (max 2 mg/dose) every 6-8 hours, or 0.05 mg/kg (max 2 mg) at bedtime for insomnia. Close monitoring required.
Adolescent: Similar to adult dosing, but start with lower doses and titrate carefully (e.g., 0.5-1 mg/day initially).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed.
Moderate: No specific adjustment typically needed, but monitor for increased sedation.
Severe: Consider lower initial doses (e.g., 50% of usual dose) and titrate carefully due to potential for accumulation of active glucuronide metabolite.
Dialysis: Lorazepam is not significantly dialyzable. No supplemental dose needed after dialysis, but monitor for increased effects.

Hepatic Impairment:

Mild: No specific adjustment typically needed.
Moderate: Consider lower initial doses (e.g., 50% of usual dose) and titrate carefully due to impaired metabolism and increased sensitivity.
Severe: Contraindicated or use with extreme caution; significantly reduced clearance, increased risk of encephalopathy. Start with very low doses (e.g., 0.5 mg/day) and monitor closely.

Pharmacology

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Mechanism of Action

Lorazepam is a benzodiazepine that binds to stereospecific benzodiazepine receptors on the postsynaptic GABA-A neuron at various sites within the central nervous system, including the limbic system, reticular formation, and cerebral cortex. It enhances the inhibitory effects of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the CNS, by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuron and reduced neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: Oral: 1-2 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

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

Elimination:

HalfLife: Approximately 10-20 hours (parent drug); 18 hours (glucuronide metabolite)
Clearance: Approximately 0.9 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugate)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Oral: 15-45 minutes
PeakEffect: Oral: 2-4 hours
DurationOfAction: Oral: 6-8 hours (clinical effects), up to 24 hours (pharmacological effects)

Safety & Warnings

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BLACK BOX WARNING

WARNINGS: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND WITHDRAWAL REACTIONS
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 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. After initiating lorazepam, monitor patients regularly for the development of these behaviors or conditions.
Continued use of benzodiazepines, including lorazepam, may lead to physical dependence. The risk of withdrawal reactions increases with longer duration of use and higher doses. Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. 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

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 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 yellowing of the skin or eyes
Severe breathing problems, including slow, shallow, or difficult breathing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Dizziness
Drowsiness
Fatigue
Weakness
Headache

Reporting Side Effects

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
  • Slow or shallow breathing
  • Severe dizziness or lightheadedness
  • Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
  • Yellowing of 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 problems
+ Kidney disease or liver disease

This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:

Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without 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 operating a vehicle or engaging in activities that require alertness, wait until you understand how this medication affects you. Additionally, avoid consuming alcohol while taking this drug, as it may exacerbate its effects.

Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) medications that may cause drowsiness or impair 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 medication's effectiveness. If you experience a decrease in the medication's 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:

  • Severe 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 or call 911. For poison control, call 1-800-222-1222. Overdose management may include supportive care, airway management, and administration of flumazenil (a benzodiazepine receptor antagonist) in specific cases, though flumazenil carries risks, especially in patients with benzodiazepine dependence or seizure disorders.

Drug Interactions

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Major Interactions

  • Opioids (e.g., fentanyl, oxycodone, hydrocodone): Concomitant use increases the risk of profound sedation, respiratory depression, coma, and death. Reserve for use in patients for whom alternative treatment options are inadequate.
  • Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, sedating antihistamines, tricyclic antidepressants, muscle relaxants): Additive CNS depressant effects, increased risk of sedation and respiratory depression.
  • Clozapine: Increased risk of severe sedation, respiratory depression, and hypotension.
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Moderate Interactions

  • Valproate: May increase lorazepam plasma concentrations and enhance its effects by inhibiting glucuronidation. Reduce lorazepam dose by approximately 50% if co-administered.
  • Probenecid: May increase lorazepam plasma concentrations and prolong its half-life by inhibiting glucuronidation. Reduce lorazepam dose by approximately 50% if co-administered.
  • Scopolamine: Increased incidence of sedation, hallucinations, and irrational behavior.
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Minor Interactions

  • Oral contraceptives: May slightly decrease lorazepam clearance, but generally not clinically significant.

Monitoring

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Baseline Monitoring

Mental status and level of consciousness

Rationale: To establish baseline neurological function and assess for pre-existing sedation or cognitive impairment.

Timing: Prior to initiation of therapy.

Respiratory rate and oxygen saturation

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

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, as lorazepam is metabolized in the liver and impairment may require dose adjustment.

Timing: Prior to initiation, especially in patients with suspected hepatic impairment or for prolonged therapy.

Renal function (BUN, creatinine)

Rationale: To assess baseline renal function, as metabolites are renally excreted and impairment may require dose adjustment.

Timing: Prior to initiation, especially in patients with suspected renal impairment or for prolonged therapy.

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Routine Monitoring

Sedation level/Level of consciousness

Frequency: Daily or as clinically indicated, especially during dose titration or with concomitant CNS depressants.

Target: Desired therapeutic effect (e.g., reduced anxiety, improved sleep) without excessive sedation.

Action Threshold: Excessive drowsiness, slurred speech, ataxia, or unresponsiveness; consider dose reduction or discontinuation.

Respiratory rate and effort

Frequency: Regularly, especially with higher doses or concomitant opioid use.

Target: Normal respiratory rate for age, unlabored breathing.

Action Threshold: Bradypnea, shallow breathing, or signs of respiratory distress; intervene immediately.

Anxiety/Insomnia symptoms

Frequency: Periodically, to assess therapeutic efficacy.

Target: Reduction in target symptoms.

Action Threshold: Lack of efficacy after appropriate dose titration; consider alternative therapy.

Signs of dependence/withdrawal

Frequency: Regularly, especially with prolonged use or during dose reduction/discontinuation.

Target: Absence of withdrawal symptoms (e.g., rebound anxiety, insomnia, seizures).

Action Threshold: Emergence of withdrawal symptoms; consider slower taper or re-evaluation of treatment plan.

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Symptom Monitoring

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

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, though less studied than first trimester.
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, hypothermia, respiratory depression, feeding difficulties) if used late in pregnancy. Risk of neonatal withdrawal symptoms (e.g., irritability, hypertonia, tremors, feeding difficulties, seizures) if used chronically during pregnancy.
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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. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Infant Risk: L3 (Moderately safe, but caution advised). Potential for sedation, lethargy, and poor feeding in the infant. Use lowest effective dose and monitor infant closely. Consider alternatives if possible.
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Pediatric Use

Use with caution. Safety and effectiveness in pediatric patients (<18 years) have not been established for oral solution. Off-label use for anxiety or insomnia should be carefully considered due to potential for paradoxical reactions, respiratory depression, and long-term developmental effects. Dosing must be individualized and closely monitored.

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Geriatric Use

Elderly patients are more sensitive to the effects of benzodiazepines and may be at increased risk for adverse effects, including sedation, dizziness, ataxia, and falls. Start with lower doses (e.g., 0.5-1 mg/day initially) and titrate slowly. Monitor closely for CNS depression and cognitive impairment. Renal and hepatic impairment are more common in the elderly, requiring further dose adjustments.

Clinical Information

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Clinical Pearls

  • Lorazepam has a relatively short-to-intermediate half-life compared to some other benzodiazepines, making it useful for acute anxiety, insomnia, and status epilepticus (IV formulation).
  • Unlike many other benzodiazepines, lorazepam is metabolized primarily by glucuronidation, which is less affected by CYP450 enzyme inhibitors/inducers, making it a preferred benzodiazepine in patients with liver disease (though dose adjustment is still needed in severe impairment) or those on medications that significantly interact with CYP450 enzymes.
  • High potential for physical and psychological dependence, especially with prolonged use. Tapering is crucial to avoid severe withdrawal symptoms.
  • The oral solution (drops) allows for flexible and precise dosing, which is particularly useful for titration or in patients who have difficulty swallowing tablets.
  • Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in pediatric and geriatric patients, or those with psychiatric disorders.
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Alternative Therapies

  • Other Benzodiazepines (e.g., Alprazolam, Diazepam, Clonazepam - for anxiety/panic/seizures)
  • SSRIs (Selective Serotonin Reuptake Inhibitors - e.g., Sertraline, Escitalopram - for anxiety/panic/depression, first-line for long-term management)
  • SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors - e.g., Venlafaxine, Duloxetine - for anxiety/depression)
  • Buspirone (for generalized anxiety disorder, non-sedating, non-addictive)
  • Hydroxyzine (antihistamine with anxiolytic/sedative properties)
  • Beta-blockers (e.g., Propranolol - for performance anxiety, physical symptoms of anxiety)
  • Non-benzodiazepine hypnotics (e.g., Zolpidem, Zopiclone, Eszopiclone - for insomnia)
  • Antidepressants with sedative properties (e.g., Trazodone, Mirtazapine - for insomnia)
  • Cognitive Behavioral Therapy (CBT) and other psychotherapies (for anxiety, insomnia, panic disorder)
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Cost & Coverage

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

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

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the amount consumed, and the time it occurred.