Diazepam 5mg/ml Inj, 10ml
Overview
What is this medicine?
How to Use This Medicine
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid alcohol and other sedating medications (e.g., opioids, sleeping pills) unless specifically instructed by your doctor, as this can cause dangerous breathing problems and extreme drowsiness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Do not stop this medication suddenly if you have been taking it regularly, as this can lead to withdrawal symptoms, including seizures. Your doctor will help you taper off slowly if needed.
Available Forms & Alternatives
Available Strengths:
- Diazepam 2mg Tablets
- Diazepam 5mg Tablets
- Diazepam 10mg Tablets
- Diazepam 5mg/5ml (1mg/1ml) Oral Sol
- Diazepam 5mg/1ml Oral Concentrate
- Diazepam 5mg/ml Inj, 2ml
- Diazepam 5mg/ml Inj, 10ml
- Diazepam 20mg Rectal Gel
- Diazepam 10mg Rectal Gel( 2 Pack)
- Diazepam 2.5mg Rectal Gel (2 Pack)
- Diazepam 5mg/ml Inj, 2ml
- Diazepam 10mg Rectal Gel (2 Pack)
- Diazepam 20mg Rectal Gel
- Diazepam 10mg/2ml Inj, 2ml
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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
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 (especially if you have a history of suicidal thoughts or actions)
New or worsening symptoms of depression, nervousness, restlessness, irritability, panic attacks, or mood changes
If you are receiving this medication through injection (I.V.), be aware that it may cause tissue damage if the drug leaks from the vein. Inform your nurse immediately if you experience:
Redness
Burning
Pain
Swelling
Blisters
Skin sores
Leaking of fluid at the injection site
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 report any concerns to your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Feeling sleepy
Feeling tired or weak
Muscle weakness
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.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Confusion or unusual thoughts/behavior
- Slurred speech
- Unsteadiness or difficulty walking
- Yellowing of skin or eyes (jaundice)
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
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 breast-feeding or plan to breast-feed, as you may need to avoid nursing while taking this medication
If the patient is a child, as this medication may not be suitable for all ages of children
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 consulting your doctor first.
Precautions & Cautions
Before operating a vehicle or engaging in activities that require alertness and clear vision, ensure you understand how this medication affects you. 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 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 lead to 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 result in tolerance, reducing its effectiveness. If you suspect this medication is no longer working as intended, contact your doctor. Avoid exceeding the prescribed dose.
Some formulations of this medication may contain benzyl alcohol. If possible, avoid products containing benzyl alcohol in newborns and infants, as high doses can cause serious side effects, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, exercise caution when administering this medication, as the risk of certain side effects may be higher in this population.
This medication may pose a risk to the unborn baby if taken during pregnancy. If you become pregnant or are already pregnant while taking this medication, 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.
Overdose Information
Overdose Symptoms:
- Extreme drowsiness
- Confusion
- Slurred speech
- Slowed reflexes
- Lack of coordination
- Profound sedation
- Respiratory depression (slow or stopped breathing)
- Hypotension
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose may require supportive care, including respiratory support, and potentially administration of flumazenil (a benzodiazepine antagonist), though flumazenil carries risks, especially in patients with chronic benzodiazepine use or seizure disorders.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4/2C19 inhibitors (e.g., fluvoxamine, ketoconazole, itraconazole, voriconazole, cimetidine, fluoxetine, omeprazole) - relative contraindication, requires significant dose reduction and close monitoring.
- Opioids (concomitant use is a Black Box Warning, not an absolute contraindication but requires extreme caution and avoidance if possible).
Major Interactions
- Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics, general anesthetics) - increased risk of profound sedation, respiratory depression, coma, and death.
- CYP3A4/2C19 inhibitors (e.g., diltiazem, verapamil, grapefruit juice) - increased diazepam levels.
- CYP3A4/2C19 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased diazepam levels.
- Phenytoin - variable effect on phenytoin levels (increase or decrease).
Moderate Interactions
- Digoxin - may increase digoxin levels.
- Levodopa - may decrease levodopa efficacy.
- Theophylline - may antagonize sedative effects of diazepam.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline vital signs and assess for pre-existing respiratory compromise.
Timing: Prior to administration.
Rationale: To establish baseline mental status and guide titration.
Timing: Prior to administration.
Rationale: Diazepam is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment or for long-term use.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Frequency: Every 5-15 minutes during acute administration and for several hours post-administration, then as clinically indicated.
Target: Respiratory rate: 12-20 breaths/min; SpO2: >92-94%
Action Threshold: Respiratory rate <10 breaths/min, SpO2 <90%, or signs of respiratory distress; administer oxygen, consider reversal agent (flumazenil) if appropriate, provide ventilatory support.
Frequency: Every 5-15 minutes during acute administration and for several hours post-administration, then as clinically indicated.
Target: Within patient's normal range.
Action Threshold: Significant hypotension or bradycardia; provide supportive care.
Frequency: Every 5-15 minutes during acute administration and for several hours post-administration, then as clinically indicated.
Target: Desired level of sedation (e.g., calm, drowsy but arousable).
Action Threshold: Excessive sedation (e.g., unarousable, stupor); reduce dose, consider reversal agent (flumazenil) if appropriate.
Symptom Monitoring
- Excessive sedation
- Respiratory depression (slow, shallow breathing)
- Hypotension
- Paradoxical reactions (agitation, hallucinations, aggression, especially in pediatric or elderly patients)
- Signs of withdrawal (anxiety, insomnia, tremors, seizures) if abruptly discontinued after prolonged use.
Special Patient Groups
Pregnancy
Category D. Avoid use during pregnancy, especially during the first trimester and near term, due to potential risks to the fetus and neonate.
Trimester-Specific Risks:
Lactation
Excreted into breast milk. Use with caution. Monitor breastfed infant for sedation, poor feeding, and weight gain.
Pediatric Use
Use with extreme caution, especially in neonates and infants, due to increased risk of respiratory depression and paradoxical reactions (e.g., hyperactivity, agitation). Dosing must be carefully calculated based on weight and age. Not recommended for routine anxiety in children.
Geriatric Use
Increased sensitivity to the sedative and respiratory depressant effects. Reduced metabolism and elimination lead to prolonged half-life and accumulation. Start with lower doses (e.g., 50% of adult dose) and titrate slowly. Increased risk of falls, cognitive impairment, and paradoxical reactions.
Clinical Information
Clinical Pearls
- IV administration should be performed slowly (max 5 mg/min) into a large vein to minimize the risk of venous irritation, thrombophlebitis, and hypotension.
- IM administration is not preferred for acute indications (e.g., status epilepticus) due to slow and erratic absorption.
- Diazepam injection contains propylene glycol and ethanol, which can cause adverse effects (e.g., metabolic acidosis, hyperosmolarity, renal dysfunction) with high doses or prolonged infusions, especially in neonates or patients with renal impairment.
- Tolerance, physical dependence, and withdrawal symptoms can occur with prolonged use. Tapering is necessary upon discontinuation.
- Paradoxical reactions (e.g., agitation, aggression, hallucinations) can occur, especially in children, elderly, or patients with psychiatric disorders.
Alternative Therapies
- For anxiety: Buspirone, SSRIs, SNRIs, hydroxyzine.
- For status epilepticus: Levetiracetam, fosphenytoin, valproic acid (non-benzodiazepine anticonvulsants).
- For muscle spasm: Baclofen, tizanidine, cyclobenzaprine (other skeletal muscle relaxants).
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information about its use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your 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 care.