Diazepam 5mg/ml Inj, 2ml

Diazepam enhances the effect of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, at the GABA-A receptor. It binds to specific benzodiazepine sites on the GABA-A receptor complex, leading to an increased frequency of chloride channel opening. This results in neuronal hyperpolarization, which inhibits neuronal excitation, producing anxiolytic, sedative, hypnotic, anticonvulsant, and muscle relaxant effects.

Urgent Side Effects: Seek Medical Help Right Away

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 passing out
Muscle spasm
Twitching
Trouble sleeping
Change in eyesight
Slurred speech
Severe upset stomach, vomiting, or loss of appetite that does not go away

Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, especially in people with a history of suicidal thoughts or actions. If you experience any new or worsening symptoms, such as:

Depression
Feeling nervous, restless, or irritable
Panic attacks
Other changes in mood or behavior

contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.

Injection (I.V.)-Related Side Effects

If you receive this medication through an 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 Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Feeling sleepy
Feeling tired or weak
Muscle weakness
Irritation at the injection site

This is not a comprehensive list of all 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.

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 breast-feeding or plan to breast-feed, 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.

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 when driving or performing tasks that require alertness and clear vision until you understand how it affects you.

To minimize potential risks, avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter (OTC) drugs that may impair your reactions or judgment.

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

This medication may cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, consult your doctor to discuss potential strategies for minimizing this risk.

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 of this medication or taking it at high doses may result in tolerance, reducing its effectiveness. If you suspect this medication is no longer working as intended, contact your doctor. However, do not exceed the prescribed dose, as this can lead to adverse effects.

Some formulations of this medication may contain benzyl alcohol. If you are administering this medication to a newborn or infant, it is crucial to avoid products containing benzyl alcohol, as it can cause severe side effects in these age groups, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if the prescribed product contains benzyl alcohol.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, 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 risks to the unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, inform 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 and benefits with your doctor.

• Strong CYP3A4 and CYP2C19 inhibitors (e.g., ketoconazole, itraconazole, fluvoxamine, fluoxetine) due to increased diazepam exposure and risk of prolonged sedation.
• Opioids (concomitant use significantly increases risk of respiratory depression, profound sedation, coma, and death).

• Other CNS depressants (e.g., alcohol, barbiturates, other benzodiazepines, general anesthetics, tricyclic antidepressants, antipsychotics, antihistamines, muscle relaxants) due to additive CNS depressant effects.
• Sodium oxybate (GHB) due to profound CNS depression.
• Cimetidine, omeprazole, esomeprazole (inhibit diazepam metabolism, increasing levels).

• Antacids (may delay oral absorption, not relevant for injection).
• Disulfiram (inhibits diazepam metabolism).
• Oral contraceptives (may inhibit diazepam metabolism).
• Theophylline (may antagonize benzodiazepine effects).

• Not available

• Excessive sedation or drowsiness
• Dizziness or lightheadedness
• Ataxia or unsteadiness
• Slurred speech
• Difficulty breathing or shallow breathing
• Paradoxical reactions (e.g., agitation, anxiety, hallucinations, aggression, rage)
• Memory impairment (anterograde amnesia)
• Signs of withdrawal upon abrupt discontinuation (e.g., seizures, tremors, anxiety, insomnia, muscle cramps)

Diazepam is classified as Pregnancy Category D, indicating positive evidence of human fetal risk. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Diazepam and its active metabolites are excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. Use with caution.

Use with caution, especially in neonates and young infants, due to immature metabolic pathways and increased sensitivity to CNS depressant effects. Dosing must be carefully calculated based on weight and age. Prolonged use can lead to physical dependence and withdrawal.

Elderly patients are more sensitive to the effects of benzodiazepines and have a prolonged elimination half-life of diazepam and its active metabolites due to decreased hepatic metabolism. This increases the risk of excessive sedation, respiratory depression, cognitive impairment, and falls. Lower initial doses and careful titration are recommended. Avoid long-term use if possible.

• IV diazepam should be administered slowly (max 5 mg/min) into a large vein to minimize the risk of venous irritation, thrombophlebitis, and local pain.
• Do not mix or dilute diazepam injection with other solutions or drugs in the syringe or infusion bottle, as precipitation may occur.
• IM administration of diazepam is generally not recommended for acute indications due to erratic and slow absorption; IV route is preferred for rapid effect.
• Patients should remain recumbent for at least 30 minutes after IV administration due to potential for hypotension and sedation.
• Tolerance and physical dependence can develop with chronic use; withdrawal symptoms can be severe and life-threatening if discontinued abruptly.
• Paradoxical reactions (e.g., excitement, agitation, hallucinations) can occur, especially in pediatric, geriatric, or psychiatric patients.

• For acute anxiety/agitation: Lorazepam (IV), Midazolam (IV)
• For status epilepticus: Lorazepam (IV), Midazolam (IM/buccal/nasal), Phenytoin (IV), Fosphenytoin (IV), Levetiracetam (IV)
• For muscle spasms: Baclofen, Tizanidine, Cyclobenzaprine
• For alcohol withdrawal: Lorazepam (IV/oral), Oxazepam (oral), Chlordiazepoxide (oral)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the 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, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. 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 of ingestion.