Diazepam 10mg Tablets

Manufacturer MYLAN Active Ingredient Diazepam Tablets(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 your brain and nerves to produce a calming effect. It's used to treat anxiety, muscle spasms, and seizures, and also to help with alcohol withdrawal. It belongs to a class of drugs called benzodiazepines.
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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, 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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: Anxiety: 2-10 mg, 2-4 times daily; Acute alcohol withdrawal: 10 mg, 3-4 times in first 24 hours, then 5 mg, 3-4 times daily as needed; Muscle spasm: 2-10 mg, 3-4 times daily; Seizure adjunct: 2-10 mg, 2-4 times daily
Dose Range: 2 - 40 mg

Condition-Specific Dosing:

anxiety: 2-10 mg, 2-4 times daily
acute_alcohol_withdrawal: 10 mg, 3-4 times in first 24 hours, then 5 mg, 3-4 times daily as needed
muscle_spasm: 2-10 mg, 3-4 times daily
adjunctive_seizure_therapy: 2-10 mg, 2-4 times daily
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Pediatric Dosing

Neonatal: Not established (contraindicated in neonates due to risk of 'floppy infant syndrome' and respiratory depression)
Infant: Not established for general use; for status epilepticus (IV/rectal) only under strict medical supervision.
Child: Anxiety/Muscle Spasm: 1-2.5 mg, 3-4 times daily initially, gradually increased as needed and tolerated. Max 10 mg/day. Seizure adjunct: 0.12-0.8 mg/kg/day divided 3-4 times daily.
Adolescent: Similar to adult dosing, but start with lowest effective dose and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor for increased sensitivity.
Moderate: No specific adjustment needed, but monitor for increased sensitivity.
Severe: No specific adjustment needed, but monitor for increased sensitivity and accumulation of active metabolites.
Dialysis: Diazepam is highly protein-bound and not significantly removed by dialysis. No supplemental dose needed post-dialysis, but monitor for effects.

Hepatic Impairment:

Mild: Use with caution, consider lower doses.
Moderate: Significant dose reduction (e.g., 50%) recommended, or use an alternative agent not metabolized by the liver (e.g., lorazepam, oxazepam).
Severe: Contraindicated in severe hepatic insufficiency due to risk of hepatic encephalopathy and prolonged sedation.

Pharmacology

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Mechanism of Action

Diazepam 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 by increasing the frequency of chloride channel opening, leading to hyperpolarization of the neuronal membrane and decreased neuronal excitability.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100% (oral)
Tmax: 1-1.5 hours (oral)
FoodEffect: Food can delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.8-1.0 L/kg (adults), higher in children and elderly
ProteinBinding: 98-99% (primarily to albumin)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: 20-100 hours (diazepam); 30-100 hours (desmethyldiazepam)
Clearance: 20-32 mL/min (adults)
ExcretionRoute: Renal (primarily as glucuronide conjugates of metabolites)
Unchanged: <1% (urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral)
PeakEffect: 1-2 hours (oral)
DurationOfAction: 6-8 hours (clinical effects); however, active metabolites contribute to prolonged effects (up to 24-48 hours or longer with chronic use).

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, and addiction with benzodiazepines can lead to overdose or death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
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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 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.
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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)
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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 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.
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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.

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.
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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 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

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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)
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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.
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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).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

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.

Renal function (BUN, creatinine)

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.

Mental status and level of consciousness

Rationale: To establish baseline for assessing therapeutic effect and adverse events (e.g., excessive sedation).

Timing: Prior to initiation.

Respiratory rate and oxygen saturation

Rationale: To establish baseline and assess risk of respiratory depression, especially with concomitant CNS depressants.

Timing: Prior to initiation.

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Routine Monitoring

Sedation level/Level of consciousness

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.

Respiratory rate and depth

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.

Efficacy (e.g., anxiety reduction, seizure control, muscle spasm relief)

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.

Signs of dependence/withdrawal

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.

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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

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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:

First Trimester: Increased risk of congenital malformations (e.g., cleft lip/palate) if used during the first trimester, though data are conflicting.
Second Trimester: Not available
Third Trimester: Risk of 'floppy infant syndrome' (hypotonia, lethargy, feeding difficulties, hypothermia, respiratory depression) and withdrawal symptoms (e.g., hypertonia, tremor, irritability, hyperreflexia, diarrhea, vomiting, seizures) in the neonate if used late in pregnancy or during labor.
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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.

Infant Risk: Moderate concern (L3). Potential for sedation, lethargy, poor feeding, and respiratory depression in the infant. Long-term effects on neurodevelopment are unknown.
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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.

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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

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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.
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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)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (10mg)
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 amount, and the time it occurred.