Diazepam 10mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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, taking it with food may help.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Store it in a secure 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 properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Avoid alcohol and other central nervous system depressants (e.g., opioids, sleeping pills, cold/allergy medications) 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 for a long time, as this can cause withdrawal symptoms (e.g., seizures, tremors, severe anxiety). Your doctor will help you slowly reduce the dose.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and recreational drugs.
- This medication can be habit-forming. Take it exactly as prescribed and do not share it with others.
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
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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
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
Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or behaviors, particularly in people with a history of suicidal ideation. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavioral changes
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:
Feeling sleepy
Feeling tired or weak
Muscle weakness
This is not an exhaustive list of potential 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.
Seek Immediate Medical Attention If You Experience:
- Extreme drowsiness or difficulty waking up
- Slow or shallow breathing
- Bluish lips or fingernails
- Severe dizziness or lightheadedness
- Unusual changes in mood or behavior (e.g., agitation, aggression, hallucinations)
- Yellowing of the skin or eyes (jaundice)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, such as:
+ 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 pain medications like oxycodone
Additionally, if you are:
Breastfeeding or planning to breastfeed, as you may need to avoid nursing while taking this medication
Considering giving this medication to a child, note that it is not recommended for infants under 6 months of age
This medication can interact with other drugs and health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss all your health problems with your doctor
Verify that 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.
Precautions & Cautions
When starting this medication, be cautious and avoid driving or performing tasks that require alertness and clear vision until you understand how it affects you. Additionally, refrain from consuming alcohol while taking this drug.
Before using marijuana, other forms of cannabis, or prescription and over-the-counter medications that may cause drowsiness, consult with your doctor. If you experience changes in your seizures or if they worsen after initiating this medication, discuss this with your doctor promptly.
This medication can cause drowsiness and impaired alertness, increasing the risk of falls, particularly in older adults. If you have concerns, consult with your doctor. Do not adjust 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 can lead to tolerance, reducing its effectiveness. If you notice a decrease in the medication's efficacy, contact your doctor. Do not exceed the prescribed dose.
Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to side effects. Similarly, children should be closely monitored, as they may have a higher risk of certain side effects.
If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as it may harm the unborn baby. Taking this medication late in pregnancy can 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
- Ataxia (loss of coordination)
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Coma
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Flumazenil may be used as an antidote in a hospital setting, but it carries risks (e.g., precipitating withdrawal seizures).
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) in patients with severe hepatic impairment
- Opioids (Black Box Warning for concomitant use due to risk of profound sedation, respiratory depression, coma, and death)
Major Interactions
- Other CNS depressants (e.g., alcohol, barbiturates, antidepressants, antipsychotics, antihistamines, general anesthetics) - increased risk of profound sedation, respiratory depression, hypotension.
- Opioids (reiteration due to severity)
- Strong CYP3A4 and CYP2C19 inhibitors (e.g., fluvoxamine, fluoxetine, cimetidine, omeprazole) - significantly increase diazepam levels, leading to enhanced sedation and respiratory depression.
Moderate Interactions
- CYP3A4 and CYP2C19 inducers (e.g., rifampin, carbamazepine, phenytoin) - decrease diazepam levels, potentially reducing efficacy.
- Antacids - may delay absorption but not extent.
- Digoxin - may increase digoxin levels (monitor).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: Diazepam is extensively metabolized by the liver; hepatic impairment can significantly alter pharmacokinetics.
Timing: Prior to initiation, especially in patients with suspected or known hepatic dysfunction.
Rationale: Although primarily metabolized by liver, metabolites are renally excreted. Severe renal impairment may lead to accumulation of active metabolites.
Timing: Prior to initiation, especially in patients with suspected or known renal dysfunction.
Rationale: To establish baseline for assessing therapeutic effect and adverse events (e.g., excessive sedation).
Timing: Prior to initiation.
Rationale: To establish baseline and assess risk of respiratory depression, especially with concomitant CNS depressants.
Timing: Prior to initiation.
Routine Monitoring
Frequency: Daily or as needed, especially during dose titration or with concomitant CNS depressants.
Target: Alert and oriented, or mild sedation as desired for therapeutic effect.
Action Threshold: Excessive drowsiness, lethargy, confusion, or unresponsiveness; consider dose reduction or discontinuation.
Frequency: Regularly, especially during initial therapy or with concomitant opioids.
Target: Normal for patient (e.g., 12-20 breaths/min), unlabored.
Action Threshold: Bradypnea (<10 breaths/min), shallow breathing, or signs of respiratory distress; consider naloxone if opioid co-administration, respiratory support.
Frequency: Daily or as needed.
Target: Achieve therapeutic goal with minimal side effects.
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative therapy.
Frequency: Periodically, especially with long-term use.
Target: Absence of withdrawal symptoms upon dose reduction or discontinuation.
Action Threshold: Anxiety, insomnia, tremors, seizures, psychosis upon dose reduction; implement slow taper.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Confusion
- Slurred speech
- Unsteadiness/ataxia
- Difficulty breathing
- Memory impairment
- Paradoxical reactions (e.g., agitation, aggression, hallucinations)
- Signs of withdrawal (e.g., anxiety, insomnia, tremors, seizures, abdominal cramps, muscle pain, vomiting, sweating) upon discontinuation
Special Patient Groups
Pregnancy
Diazepam is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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.
Trimester-Specific Risks:
Lactation
Diazepam and its active metabolites are excreted into breast milk. Due to the long half-life and potential for accumulation in the infant, it is generally not recommended for use during breastfeeding. If use is necessary, monitor the infant for sedation, poor feeding, and weight gain.
Pediatric Use
Use with caution. Children, especially younger ones, may be more sensitive to the CNS depressant effects and may experience paradoxical reactions (e.g., hyperactivity, agitation, sleep disturbances). Dosing must be carefully individualized and titrated. Not recommended for neonates.
Geriatric Use
Elderly patients are more sensitive to the effects of benzodiazepines due to decreased metabolism, increased volume of distribution, and increased brain sensitivity. They are at higher risk for excessive sedation, dizziness, falls, and cognitive impairment. Start with the lowest effective dose (e.g., 2-2.5 mg, 1-2 times daily) and titrate slowly. Avoid long-term use if possible.
Clinical Information
Clinical Pearls
- Diazepam has a long half-life and active metabolites, leading to prolonged effects and potential for accumulation, especially with chronic use or in patients with impaired liver function.
- Due to its rapid onset of action, diazepam is often used for acute anxiety, acute alcohol withdrawal, and acute muscle spasms.
- Tolerance and physical dependence can develop with chronic use. Abrupt discontinuation can lead to severe withdrawal symptoms, including seizures. Tapering is essential.
- Paradoxical reactions (e.g., excitement, aggression, hallucinations) can occur, particularly in children, the elderly, and patients with psychiatric disorders.
- The concomitant use of opioids and benzodiazepines carries a Black Box Warning due to the risk of profound sedation, respiratory depression, coma, and death. Avoid this combination if possible, or use with extreme caution and close monitoring.
- Diazepam is available in various formulations (oral tablets, oral solution, rectal gel, injectable) allowing for flexibility in administration for different indications.
Alternative Therapies
- Other benzodiazepines (e.g., lorazepam, alprazolam, clonazepam for anxiety/seizures; temazepam for insomnia)
- SSRIs/SNRIs (for anxiety disorders, long-term management)
- Buspirone (for generalized anxiety disorder, non-sedating)
- Antihistamines (e.g., hydroxyzine for anxiety/sedation)
- Beta-blockers (e.g., propranolol for situational anxiety symptoms)
- Non-benzodiazepine hypnotics (e.g., zolpidem, zopiclone for insomnia)
- Muscle relaxants (e.g., cyclobenzaprine, tizanidine for muscle spasm)
- Anticonvulsants (e.g., levetiracetam, valproic acid, phenytoin for seizure disorders)
- Non-pharmacological therapies (e.g., cognitive behavioral therapy, psychotherapy, relaxation techniques, exercise)