Diazepam (dye-AZ-e-pam)

Treats seizure clusters (acute repetitive seizures).

Brand Name(s):

Valtoco 10mg, Valtoco 15mg, Valtoco 20mg, Valtoco 5mg

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. If a second dose is needed, take it at least 4 hours after the first dose. Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• This device is ready-to-use. Your doctor will tell you how many devices to use depending on your dose. You and your caregiver should be taught how to use this device in case a seizure cluster happens.
• To use the device:
  • Do not open the blister packs before use. Do not use the device if it looks damaged.
  • This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
  • This device sprays one time only. Do not test or prime it before use.
  • Hold the device with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
  • Gently insert the tip of the nozzle into the nostril until your fingers are against the bottom of the patient's nose.
  • Press the bottom of the plunger firmly with your thumb to give a dose.
  • Remove the device from the nostril after each dose.
  • After giving this medicine, keep or move the patient onto their side, facing you, so you can watch them closely. Loosen any tight clothing and provide a safe area, away from furniture and other objects, where they can rest.
  • Take note of the time you first give the dose, as well as the second dose if needed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine is given only during a seizure cluster episode.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how diazepam works. Tell your doctor if you are using carbamazepine, cimetidine, clotrimazole, cyclosporine, dexamethasone, imipramine, ketoconazole, omeprazole, paclitaxel, phenobarbital, phenytoin, propranolol, quinidine, rifampin, terfenadine, theophylline, tranylcypromine, troleandomycin, valproate, or warfarin.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later part of a pregnancy may cause problems in your newborn baby (including sedation or withdrawal symptoms). Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding or planning to breastfeed. This medicine passes into your breast milk and may cause problems in your baby. Talk to your doctor about the best way to feed your baby.
• Tell your doctor if you have kidney disease, liver disease, glaucoma, lung or breathing problems (including asthma, emphysema, bronchitis, COPD), or a history of drug or alcohol abuse, depression, or mental health problems.
• This medicine may cause the following problems:
  • Increased risk of overdose, which can be life-threatening
  • Respiratory depression (serious breathing problem that can be life-threatening), when used with narcotic pain medicines
  • Unusual thoughts or behavior
  • Eye or vision problems, including increased pressure in the eye
• This medicine may make you drowsy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. Your seizures may return or occur more often if you stop using this medicine suddenly.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, irritability, nervousness, unusual mood or behavior, thoughts of hurting yourself
• Blue lips, fingernails, or skin, trouble breathing, chest pain
• Blurred vision or other changes in vision, eye pain
• Change or loss of consciousness, confusion, dizziness, faintness, lightheadedness, lack of coordination, sleepiness or unusual drowsiness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Nasal itching, burning, or irritation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088