Diazepam 10mg/2ml Inj, 2ml

Manufacturer FRESENIUS KABI USA Active Ingredient Diazepam Injection(dye AZ e pam) Pronunciation dye AZ e 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 relax muscles.It is used to treat alcohol withdrawal.It is used to treat anxiety.It is used to help control certain kinds of seizures.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anxiolytic, Sedative-Hypnotic, Anticonvulsant, Skeletal Muscle Relaxant
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Pharmacologic Class
Benzodiazepine
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Pregnancy Category
Category D
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FDA Approved
Nov 1963
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Diazepam is a medication that works on the brain and nerves to produce a calming effect. It is used to treat anxiety, stop seizures (like status epilepticus), relax muscles, and help with symptoms of alcohol withdrawal. It can also be used to make you feel relaxed before a medical procedure.
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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 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 method.

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 medications that cause drowsiness (e.g., opioids, antihistamines, sleeping pills) while taking diazepam, as this can lead to dangerous breathing problems or extreme sedation.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • If you have been taking diazepam regularly, do not stop taking it suddenly without consulting your doctor, as this can lead to withdrawal symptoms (e.g., seizures, anxiety, tremors).
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and route (IV/IM)
Dose Range: 2 - 30 mg

Condition-Specific Dosing:

Acute Anxiety: 2-10 mg IV/IM, repeat in 3-4 hours if needed
Status Epilepticus: 5-10 mg IV, repeat every 10-15 minutes up to 30 mg total
Muscle Spasm: 5-10 mg IV/IM, repeat in 3-4 hours if needed
Pre-operative Sedation: 5-10 mg IM 20-30 minutes prior to procedure
Acute Alcohol Withdrawal: 10 mg IV/IM initially, then 5-10 mg in 3-4 hours if needed
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to risk of respiratory depression)
Infant: Status Epilepticus (>30 days to <5 years): 0.2-0.5 mg IV slowly every 2-5 minutes, up to 5 mg total
Child: Status Epilepticus (>=5 years): 1 mg IV slowly every 2-5 minutes, up to 10 mg total
Adolescent: Dosing similar to adult for specific indications, with caution
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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; accumulation of active metabolites may occur. Monitor closely.
Dialysis: Diazepam and its metabolites are not significantly dialyzable. Monitor for increased sedation.

Hepatic Impairment:

Mild: Start with lower doses (e.g., 50% of usual dose) and titrate carefully
Moderate: Significant dose reduction required; monitor closely for adverse effects
Severe: Avoid use or use with extreme caution and significant dose reduction; increased risk of encephalopathy

Pharmacology

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Mechanism of Action

Diazepam enhances the inhibitory effect of gamma-aminobutyric acid (GABA) at the GABA-A receptor by increasing the frequency of chloride channel opening, leading to hyperpolarization and decreased neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%
Tmax: IV: Not applicable (immediate); IM: 0.5-1.5 hours (variable)
FoodEffect: Not applicable for injection

Distribution:

Vd: 0.8-1.0 L/kg
ProteinBinding: 98%
CnssPenetration: Yes

Elimination:

HalfLife: Diazepam: 20-100 hours; Desmethyldiazepam: 30-100 hours
Clearance: 20-32 mL/min
ExcretionRoute: Renal (primarily as conjugated metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: IV: 1-5 minutes; IM: 15-30 minutes
PeakEffect: IV: 5-10 minutes
DurationOfAction: 15-60 minutes (acute effects due to redistribution); clinical effects can last 6-8 hours or more due to active metabolites

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 risks of abuse, misuse, addiction, and physical dependence with benzodiazepines are also highlighted.
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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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
Shortness of breath
Change in balance
Feeling confused
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Severe dizziness or fainting
Muscle spasms
Twitching
Trouble sleeping
Changes in eyesight
Slurred speech
Severe upset stomach, vomiting, or loss of appetite that persists
Suicidal thoughts or actions (see below for more information)

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, particularly in people who have had suicidal thoughts or actions in the past. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions

contact your doctor immediately.

Injection (I.V.)-Specific Side Effects

If you receive this medication through injection, it may cause tissue damage if the drug leaks from the vein. Inform your nurse if you experience:
Redness
Burning
Pain
Swelling
Blisters
Skin sores
Leaking of fluid at the injection site

Other Side Effects

Most people who take this medication do not experience severe side effects. However, some people may experience:
Drowsiness
Fatigue or weakness
Muscle weakness
Irritation at the injection site

If any of these side effects or other symptoms bother you or persist, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or difficulty waking up
  • Slow, shallow, or difficult breathing
  • Unusual confusion or disorientation
  • Slurred speech
  • Extreme dizziness or lightheadedness
  • Unusual mood changes, agitation, or aggression (paradoxical reactions)
  • Yellowing of the skin or eyes (jaundice)
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, 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:
+ Breathing problems
+ Glaucoma
+ Liver disease
+ Myasthenia gravis
+ Sleep apnea
If you have a history of psychosis
Recent consumption of large amounts of alcohol or use of medications that may cause drowsiness, such as phenobarbital or certain pain medications like oxycodone
If you are breastfeeding or plan to breastfeed, as you may need to avoid doing so while taking this medication
If the patient is a child, as this medication may not be suitable for all ages

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 and clear vision, wait until you understand how this medication affects you.

Refrain from consuming alcohol while taking this drug, as it may exacerbate its effects.

Prior to using marijuana, other cannabis products, or prescription and over-the-counter medications that may impair your reactions, consult with your doctor.

If you experience changes in the frequency or severity of seizures after initiating this medication, notify your doctor promptly.

This medication may cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, discuss them with your doctor.

Do not alter the dosage or discontinue this medication without consulting your doctor, as this may trigger seizures.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

Prolonged use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you suspect this is occurring, contact your doctor. Do not exceed the prescribed dose.

Certain formulations of this medication may contain benzyl alcohol. If possible, avoid products with benzyl alcohol in newborns and infants, as high doses can cause severe side effects, especially when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.

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 they may be at a higher risk of experiencing certain side effects.

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, low body temperature, or withdrawal symptoms in the newborn. Discuss the potential risks with your doctor.
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Overdose Information

Overdose Symptoms:

  • Extreme drowsiness or sedation
  • Confusion
  • Muscle weakness
  • Loss of coordination (ataxia)
  • Slow or shallow breathing (respiratory depression)
  • Hypotension (low blood pressure)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local Poison Control Center (e.g., 1-800-222-1222 in the US). Overdose management is primarily supportive care (maintaining airway, breathing, circulation). Flumazenil, a benzodiazepine antagonist, can reverse effects but carries risks (e.g., precipitating withdrawal seizures) and is generally reserved for specific situations.

Drug Interactions

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Contraindicated Interactions

  • Opioids (unless alternative treatment options are inadequate and with extreme caution)
  • Strong CYP3A4 inhibitors in patients with severe respiratory depression or acute narrow-angle glaucoma
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Major Interactions

  • Opioids (additive CNS depression, respiratory depression, profound sedation, coma, death)
  • Other CNS depressants (e.g., alcohol, barbiturates, tricyclic antidepressants, antipsychotics, antihistamines, general anesthetics) - increased risk of sedation and respiratory depression
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased diazepam levels
  • Strong CYP2C19 inhibitors (e.g., fluvoxamine, fluoxetine, omeprazole) - increased diazepam levels
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Moderate Interactions

  • CYP3A4/2C19 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased diazepam levels
  • Antacids (may delay absorption of oral forms, less relevant for injection)
  • Digoxin (may increase digoxin levels)
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Minor Interactions

  • Not many specific minor interactions listed that are clinically significant for injection beyond general caution with other sedatives.

Monitoring

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Baseline Monitoring

Respiratory rate and oxygen saturation

Rationale: To assess baseline respiratory function and risk of depression

Timing: Prior to administration

Blood pressure and heart rate

Rationale: To assess cardiovascular stability and risk of hypotension

Timing: Prior to administration

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

Rationale: To establish baseline mental status and guide titration

Timing: Prior to administration

Renal and Hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To assess organ function, especially if prolonged use or impairment suspected, as metabolism is hepatic and excretion is renal

Timing: Prior to initiation of therapy, if clinically indicated

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Routine Monitoring

Respiratory rate and oxygen saturation

Frequency: Every 5-15 minutes initially, then as clinically indicated based on patient stability

Target: Respiratory rate >10 breaths/min, SpO2 >92%

Action Threshold: Respiratory rate <10 breaths/min or SpO2 <90% (or significant drop from baseline) - intervene immediately

Blood pressure and heart rate

Frequency: Every 5-15 minutes initially, then as clinically indicated

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia - intervene

Level of consciousness/Sedation score

Frequency: Every 5-15 minutes initially, then as clinically indicated

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

Action Threshold: Excessive sedation (e.g., RASS -4 or -5) or paradoxical reaction - reduce dose or hold

Injection site for phlebitis/irritation

Frequency: Regularly during and after IV administration

Target: No redness, swelling, or pain

Action Threshold: Signs of phlebitis - discontinue infusion at site, apply warm compress

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation or somnolence
  • Hypotension
  • Dizziness or lightheadedness
  • Confusion or disorientation
  • Slurred speech
  • Ataxia or loss of coordination
  • Paradoxical reactions (e.g., agitation, anxiety, hallucinations, aggression, insomnia)
  • Injection site pain, redness, or swelling

Special Patient Groups

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Pregnancy

Category D. Should be avoided during pregnancy, especially during the first trimester due to potential risk of congenital malformations (e.g., cleft lip/palate). Use in late pregnancy can lead to 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties) and neonatal withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Potential increased risk of congenital malformations (e.g., cleft lip/palate)
Second Trimester: Less data, but generally considered safer than first or third trimester if absolutely necessary
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties), respiratory depression, and neonatal withdrawal symptoms (irritability, hypertonia, tremors, seizures) if used close to delivery.
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Lactation

Excreted into breast milk. Can cause sedation, poor feeding, and weight loss in the infant. Use with caution, monitor infant for adverse effects, or consider alternative agents with shorter half-lives or lower excretion into milk.

Infant Risk: Moderate to high risk (L3-L4) depending on dose and duration. Potential for sedation, lethargy, poor feeding, and developmental effects in the infant.
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Pediatric Use

Increased sensitivity to CNS depressant effects, especially in neonates and infants. Careful titration and close monitoring for respiratory depression and sedation are essential. Paradoxical reactions (e.g., excitement, agitation) can occur. Not recommended for routine use in neonates due to risk of gasping syndrome from benzyl alcohol preservative (if present).

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Geriatric Use

Increased sensitivity to sedative and respiratory depressant effects. Start with lower doses and titrate slowly. Increased risk of falls, cognitive impairment, and paradoxical reactions. Monitor closely for over-sedation and respiratory depression.

Clinical Information

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Clinical Pearls

  • IV administration should be slow (e.g., 1 mL/min) into a large vein to minimize venous irritation, phlebitis, and local pain. Rapid IV injection can cause apnea or cardiac arrest.
  • IM administration is generally not recommended due to erratic and incomplete absorption, but may be used if IV access is not possible (e.g., acute seizure outside hospital).
  • Tolerance and physical dependence can develop with prolonged use. Abrupt discontinuation after chronic use can lead to severe withdrawal symptoms, including seizures.
  • Paradoxical reactions (e.g., excitement, agitation, aggression) can occur, especially in children, elderly, and patients with psychiatric disorders.
  • Diazepam is highly lipid-soluble, leading to rapid onset of action but also rapid redistribution out of the CNS, which explains its relatively short duration of acute effect despite a long elimination half-life.
  • Due to its long half-life and active metabolites, accumulation can occur with repeated dosing, particularly in patients with hepatic impairment or in the elderly.
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Alternative Therapies

  • For Acute Anxiety: Lorazepam (IV), Midazolam (IV), Alprazolam (oral), Buspirone (oral, for chronic anxiety), SSRIs/SNRIs (for chronic anxiety).
  • For Status Epilepticus: Lorazepam (IV, often preferred due to longer duration of action), Midazolam (IV, IM, intranasal, buccal), Phenytoin (IV), Fosphenytoin (IV), Levetiracetam (IV), Valproic Acid (IV).
  • For Muscle Spasm: Cyclobenzaprine, Tizanidine, Baclofen, Methocarbamol (oral or IV).
  • For Alcohol Withdrawal: Lorazepam (IV/oral), Oxazepam (oral), Chlordiazepoxide (oral/IM/IV).
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Cost & Coverage

Average Cost: Highly variable per 2ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic formulations)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which can be a safe and environmentally friendly way to dispose of 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.