Valtoco is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to treat seizure clusters in adults and children at least 6 years old.

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.

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

Do not stop using diazepam without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Valtoco and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Some people have thoughts about suicide while using Valtoco. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

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

Valtoco is for use only in the nose.

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 Valtoco in larger amounts, or for longer than prescribed.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine 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, but you may need to use more than 1 bottle to get your full dose. Follow your doctor's dosing instructions very carefully.

Keep this medicine with you at all times. Be sure a responsible family member or caregiver knows where the medicine is and how to give it to you.

After giving Valtoco to another person:

• note the time the Valtoco 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.

If needed, a second dose of Valtoco nasal 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 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.

Do not stop using diazepam without asking your doctor. You may have increased seizures or life-threatening withdrawal symptoms if you stop using the medicine suddenly.

Store at room temperature away from moisture, heat, and light. Do not freeze. Keep your medicine in a place where no one can use it improperly.

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 Valtoco 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 using Valtoco. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

May harm an unborn baby. Tell your doctor if you are pregnant. If you use Valtoco during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Since Valtoco 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diazepam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

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

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.

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 or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if the person receiving this medicine 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.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common Valtoco side effects may include:

• drowsiness;

• headache; or

• discomfort in your nose.

After you stop using Valtoco, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

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.

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

Other drugs may interact with diazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.