Diazepam Nasal

Diazepam is a seizure medicine that is occasionally used for acute treatment of seizures in a hospital setting, as a rescue medicine outside of a hospital setting, and occasionally as a daily seizure medicine.

People with epilepsy may have seizures that happen in clusters. Seizure clusters are usually defined indivudally, for example  as a change in the number, pattern or type of seizures over a period of hours.

These clusters can sometimes lead to seizure emergencies that need emergency care. Seizure clusters can happen with any type of seizure. The rescue medicine forms of diazepam can be given outside of a hospital setting. They are designed to stop seizure clusters and prevent seizure emergencies.

Diazepam Nasal is one of these rescue medications.

Valtoco

Valtoco® is the brand name of diazepam nasal spray, a rescue medication made by Neurelis.

It is approved for use: 

  • For short-term treatment of seizure clusters (also called acute repetitive seizures)  
  • In children 6 years and older and in adults. people  
  • It is not supposed to be taken daily.  
  • It does not take the place of your daily seizure medicine.  
Valtoco diazepam nasal spray
 


 

 

 

 

 

 

 

 

Intranasal Spray

Used to treat

Absence Seizures
Atonic Seizures
Atypical Absence Seizures
Clonic Seizures
Focal Impaired Awareness or Complex Partial Seizures
Febrile Seizures
Myoclonic Seizures
Refractory Seizures
Secondarily Generalized Seizures or Bilateral Tonic Clonic Seizure
Focal Aware or Simple Partial Seizure
Tonic Seizures
Tonic-clonic Seizures
Unknown Onset

Forms

Nasal spray

Dosing

The prescribed dose is based on the person's weight. 

Valtoco (diazepam) nasal spray comes is:
  • 3 dose forms: 5 mg, 7.5 mg, or 10 mg of diazepam in 0.1 ml
  • Each package has 2 nasal sprays
  • The prescribed dose depends on the person’s weight. 
    • The 5 and 10 mg doses are given as a single nasal spray into one side of the nose. 
    • A 15 mg dose is given with two (2) 7.5 mg nasal devices. Spray one(1) into each side of the nose.
    • A 20 mg dose is given with two (2) 10 mg nasal devices. Spray one(1) into each side of the nose. 
How to take and store Diazepam Nasal?

How to take:

  • Each device can be used once
  • A person can give the nasal spray to themselves if they are not having a seizure at the time. If the medicine is meant to be given during or after a seizure, a family or care partner should be taught how to use it.
  • Hold the nasal spray with one finger on each side of the nozzle. Do not prime the pump or push it in until it is ready to be used. 
  • Place the nozzle in one nostril or side of the nose and push the plunger in to give the medicine. Remove the nasal spray device.
    • If 2 nasal sprays are needed for the 15 or 20 mg doses, give one spray into each side of the nose. 
  • Follow the providers orders for observing the person afterwards. Watch for continued seizures and side effects. 
  • If a second dose is needed for more seizures, it can be given 4 hours or more after the first dose.
  • Do not use more the 2 doses of Valtoco for one seizure cluster. 
  • It is recommended that Valtoco not be used more often than every 5 days or more than 5 times a month. 
  • Talk to your treating provider if more frequent use seems needed.

How to store:

  • Keep the medicine in a place that is easy to get when it is needed. 
  • Keep them in their original container tightly closed, away from light, and out of reach of children. 
  • Store your prescription at room temperature away from excess heat and moisture (i.e. not the bathroom). 
  • Throw away any medication that is outdated or no longer needed.
What if I forget?

These medicines are designed to be used only if needed as a rescue treatment. They are not designed to be used daily, and should not replace a patients daily anti-seizure medication. Do not take an extra dose unless prescribed by your doctor.

 

How does Diazepam Nasal affect the brain?

The exact way that diazepam works to stop seizures is not known. It appears to suppress or stop seizure activity by affecting a substance in the brain called GABA (gamma-aminobutyric acid). 

How does the body digest Diazepam Nasal?
  • Valtoco is well absorbed from the nose. It reaches peak or highest amounts in the bloodstream in 1.5 hours but starts working sooner. 
  • Diazepam has a half-life in adults of about 49 hours. This means that it may stay at a level in the body that can help seizures for about 2 days. 
  • In children, nasal diazepam has a half-life of 15 to 21 hours.
  • Most of the diazepam is bound to proteins in the blood stream.
  • Diazepam is broken down in the liver to metabolites or breakdown products that can also have effects on seizures. 
How well does the Diazepam Nasal work?
Diastat was studied in controlled studies comparing it to placebo (an inactive substance) in children and adults. 
  • People were given the first dose of Diastat when the seizure was first seen. 
    • Children were given a second dose 4 hours later
    • Adults were given doses 4 and 12 hours after the first dose. 
  • About 2/3 of people treated with Diastat were seizure free during an observation period – 12 hours for children and 24 hours for adults. Only 20% of people who were given placebo were seizure during the observation time. 
Valtoco was studied to see how it worked in relation to Diastat
  • The way it worked in the body was similar for Diastat and Valtoco. 
  • In a long term study that evaluated how well people did taking Valtoco, the majority of people only needed one dose of Valtoco. 
    • 96% of people by 4 hours 
    • 94%  of people by 6 hours
    • 91% of people by 12 hours
    • 86% of people over 24 hours

Approval of Valtoco was based primarily upon the drugs bioavailability compared to Diastat. In these studies, the systemic exposure (AUC) and maximal peak concentrations (Cmax) of diazepam was similar between Diastat and  Valtoco. Safety of Valtoco in pediatric patients was also confirmed in open-label studies. With regard to how well Valtoco works, both safety and efficacy were established based primarily upon studies done with Diastat.

What are the most common side effects of Diazepam Nasal?

The most frequent side effect of Diastat is sleepiness. Other reported side effects include:

  • Dizziness
  • Headache
  • Pain
  • Nervousness
  • Diarrhea
  • Unsteady walking
  • Behavior change
  • Poor coordination
  • Asthma
  • Runny nose
  • Rash (2 to 5 %)
  • Vasodilation (light-headedness from low blood pressure may occur)
Some common side effects of Valtoco include:
  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort or congestion
Nose bleeds and a bad taste after use have also been reported. This nasal formulation has benzyl alcohol which might cause CNS depression, metabolic acidosis and gasping respirations in newborns and infants. Consult with your health care provider before using this product in babies. 
What are the most serious side effects of Diazepam Nasal?
  • Usually the benefits of Diastat far outweigh the mild to moderate side effects.
  • Side effects generally go away within hours, and with no lasting harm. 
  • Serious problems are very rare.

Breathing Problems:

  • People given diazepam by injection occasionally need help with breathing, especially if they have other breathing problems or have taken sedating medicines.
  • Breathing problems are extremely rare when either Diastat or Valtoco are used. The risk is slightly higher when more than one dose is given.
  • Caregivers should watch for signs of breathing problems (for example, slowed breathing or a change in the color of the skin) and call for help if needed. 

Central Nervous System Depression

All benzodiazepines can cause CNS depression which means it affects how the brain may work.

  • For example, the medicines may cause drowsiness, affect alertness and thinking. 
  • If a person feels very sleepy, dizzy or uncoordinated for a period after using one of these medicines, they should avoid activities where they could get injured.

Suicidal Thoughts and Behavior

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10.

Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions:

  • Do not make any changes to the medication regimen without first talking with the responsible healthcare professional.
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.

Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:

  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Changes in Vision (Glaucoma): Diazepam may cause an increase in eye pressure in people with open-angle glaucoma. 

Other potentially serious side effects: Increased seizure tolerance

  • Some people with epilepsy who take diazepam or other benzodiazepines daily may have more frequent or severe seizures if the medicine is lowered or stopped. 
  • Developing tolerance and needing a higher dose to get the same effect could also be a problem with daily diazepam. 
  • Since Diastat and Valtoco are not used daily, these concerns are much less likely to arise. 

 

Impact of Diazepam Nasal on bone health

Nothing listed.

What else is Diazepam Nasal used for?

Valtoco is only approved for treatment of seizure clusters.

Who should not take Diazepam Nasal?
  • People with a known sensitivity to diazepam.
  • People who have an eye condition called acute narrow angle glaucoma. People with open angle glaucoma may use it.
Can Diazepam Nasal be taken with other medicines?

Caution needs to be taken when taking any diazepam product with alcohol, pain medications and other antianxiety medications.

What are the effects of Diazepam Nasal on Children?

See package insert.

If a woman takes Diazepam Nasal during pregnancy will it hurt the baby?

See package insert.

What are the effects of Diazepam Nasal on Seniors

Extra caution is needed when diazepam is used in older adults or those with liver or kidney disease. The medicine may last longer in their body and could lead to higher amounts of medicine in the body. They may be more likely to develop side effects like drowsiness, unsteadiness, or breathing problems.

See package insert

Read the package insert of Diazepam Nasal

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Diastat (diazepam) is found at:In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Valtoco (diazepam) is found at:

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see "How to read a package insert."

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The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

 
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