Valtoco (diazepam) Nasal Spray

Generic name: diazepam nasal (dye AZ e pam)
Brand name: Valtoco
Drug class: Benzodiazepine anticonvulsants

Valtoco (diazepam) is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) anticonvulsant medicine.

Valtoco nasal spray is a prescription medicine used for the short-term treatment of seizure clusters (also known as "acute repetitive seizures") in adults and children at least 6 years old.

Valtoco is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.

It is not known if Valtoco is safe and effective in children under 6 years of age.

Warnings

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.

MISUSE OF VALTOCO CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Some people have thoughts about suicide while using Valtoco. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not use Valtoco nasal spray if you have an eye problem called acute narrow angle glaucoma.

Before taking this medicine

You should not use Valtoco if you are allergic to diazepam (Valium), or if you have:

  • narrow-angle glaucoma.

Valtoco is not approved for use by anyone younger than 6 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had

  • glaucoma;
  • asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
  • liver or kidney disease;
  • a drug or alcohol addiction; or
  • depression, a mood disorder, or suicidal thoughts or behavior.

Some people have thoughts about suicide while taking diazepam. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not start or stop using seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of diazepam on the baby.

It may not be safe to breastfeed while using Valtoco. Ask your doctor about any risk.

How should I use Valtoco?

Use Valtoco nasal spray exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Never use diazepam in larger amounts, or for longer than prescribed.

Never share Valtoco with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Valtoco is a nasal spray that comes in a ready-to-use bottle. Each bottle is for one use only. Use only the number of sprays your doctor has prescribed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Be sure a responsible family member or caregiver knows where you keep Valtoco and how to give it to you.

After giving a dose of Valtoco nasal spray to another person:

  • note the time the dose was given;
  • keep the person lying on his or her side;
  • stay with the person and watch for changes in his or her seizures.

Seek emergency medical help if the person's seizure seems different or last longer than other seizures, or if the person has slow breathing, blue colored lips, or is hard to wake up.

If needed, a second dose of Valtoco may be given at least 4 hours after the first dose. Do not give a second dose if the person has extreme drowsiness or very slow breathing.

Diazepam doses are based on weight. Your dose needs may change if you gain or lose weight.

Do not use more than 2 doses to treat a single seizure cluster episode.

Do not use Valtoco for more than 1 seizure cluster every 5 days. Do not use for more than 5 seizure clusters in 1 month.

If you stop using Valtoco suddenly after long-term use, you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Since this medicine is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

Keep Valtoco nasal spray with you at all times in case you need it to control seizure clusters.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, confusion, or loss of consciousness.

What should I avoid while using Valtoco?

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how Valtoco will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Valtoco side effects

Get emergency medical help if you have signs of an allergic reaction to Valtoco: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if the person receiving this medication has:

  • extreme weakness or drowsiness;
  • unusual changes in mood or behavior;
  • new or worsening symptoms of depression or anxiety;
  • thoughts of suicide or hurting yourself;
  • sleep problems; or
  • new or worsening seizures.

The sedative effects of diazepam may last longer in older adults. Accidental falls are common in elderly patients who use benzodiazepines. Use caution to avoid falling or accidental injury while you are using this medicine.

Common Valtoco side effects may include:

  • drowsiness;
  • headache; or
  • discomfort in your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Valtoco?

Using Valtoco with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, opioid medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with diazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.