Pronunciation:

dye-AZ-e-pam

Brand Names:

• Valtoco

Dosage Forms:

• Spray

Warnings:

Risks From Concomitant use with Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression.The use of benzodiazepines, including diazepam nasal spray, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with increased frequency of serious adverse outcomes. Before prescribing diazepam nasal spray and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although diazepam nasal spray is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of diazepam nasal spray may precipitate acute withdrawal reactions, which can be life-threatening. For patients using diazepam nasal spray more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam nasal spray .

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Benzodiazepine, Long Acting

Uses of This Medicine:

Diazepam nasal spray is used as short-term treatment for seizure clusters (also known as "acute repetitive seizures") in patients 6 years of age and older. Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of diazepam nasal spray in children younger than 6 years of age. Safety and efficacy have not been established. Diazepam nasal spray should not be used in infants and babies.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam nasal spray in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, clumsiness, or unsteadiness), which may require caution and an adjustment in the dose for patients receiving diazepam nasal spray.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprepitant
• Aripiprazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlorzoxazone
• Clobazam
• Clonazepam
• Cobicistat
• Codeine
• Conivaptan
• Dabrafenib
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Doxylamine
• Esketamine
• Eslicarbazepine Acetate
• Ethchlorvynol
• Ethylmorphine
• Etravirine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ivacaftor
• Ketamine
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Nicomorphine
• Olanzapine
• Omaveloxolone
• Omeprazole
• Opium
• Opium Alkaloids
• Orlistat
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Phenytoin
• Piritramide
• Potassium Oxybate
• Pregabalin
• Primidone
• Propofol
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sparsentan
• Sufentanil
• Tapentadol
• Thiopental
• Tilidine
• Tocilizumab
• Topiramate
• Tramadol
• Trazodone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Amprenavir
• Clarithromycin
• Dalfopristin
• Desogestrel
• Dienogest
• Disulfiram
• Drospirenone
• Erythromycin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fluoxetine
• Gestodene
• Ginkgo
• Isoniazid
• Levonorgestrel
• Mestranol
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Quinupristin
• Rifapentine
• Roxithromycin
• St John's Wort
• Theophylline
• Troleandomycin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or drug abuse or dependence, or history of or
• Depression, or history of or
• Lung or breathing problems (eg, asthma, emphysema, bronchitis, COPD) or
• Mental health problems, or history of—Use with caution. May make these conditions worse.

• Glaucoma, acute narrow-angle—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 nasal device:

• Do not open the blister packs before use. Do not use the device if it looks damaged.
• This medicine is for use only inside the nose. Do not get any of it into 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.

If a second dose is needed, take it at least 4 hours after the first dose. Do not use more than 2 doses of diazepam to treat a single episode.

Do not use this medicine for more than 1 episode every 5 days or more than 5 episodes per month.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (solution):
  • For seizure clusters:
    • Adults and children 12 years of age and older—The dose is 0.2 milligram (mg) per kilogram (kg) body weight and must be determined by your doctor.
      • Weighing 76 kg and more—20 milligrams (mg) or two 10 mg devices per day. Spray once in each nostril.
      • Weighing 51 kg to 75 kg—15 mg or two 7.5 mg devices per day. Spray once in each nostril.
      • Weighing 28 kg to 50 kg—10 mg or one 10 mg device per day. Spray once in one nostril only.
      • Weighing 14 kg to 27 kg—5 mg or one 5 mg device per day. Spray once in one nostril only.
    • Children 6 to 11 years of age—The dose is 0.3 milligram (mg) per kilogram (kg) body weight and must be determined by your doctor.
      • Weighing 56 kg to 74 kg—20 mg or two 10 mg devices per day. Spray once in each nostril.
      • Weighing 38 kg to 55 kg—15 mg or two 7.5 mg devices per day. Spray once in each nostril.
      • Weighing 19 kg to 37 kg—10 mg or one 10 mg device per day. Spray once in one nostril only.
      • Weighing 10 kg to 18 kg—5 mg or one 5 mg device per day. Spray once in one nostril only.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

This medicine is used only during a seizure cluster episode.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly.

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 (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause respiratory depression, a serious breathing problem that can be life-threatening, when used together with narcotic pain medicines. Check with your doctor right away if you have pale or blue lips, fingernails, or skin, difficult or trouble breathing, or irregular, fast or slow, or shallow breathing.

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 may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Check with your doctor before using this medicine with alcohol or medicines that can affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with diazepam may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Symptoms of an overdose include: change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, irregular, fast or slow, or shallow breathing, lack of coordination, loss of strength or energy, muscle pain or weakness, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms including burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings, continuing ringing or buzzing or other unexplained noise in the ears, discouragement, false feeling of insects crawling on the skin, feeling sad or empty, hearing loss, irritability, lack of appetite, loss of interest or pleasure, trouble concentrating, or trouble sleeping.

This medicine contains benzyl alcohol which may cause serious reactions to newborn, premature, or low-birthweight infants. Discuss this with your doctor if you are concerned.

Call your doctor right away:

• If your seizures still continue after using this medicine.
• If your seizures are different from your previous episodes.
• If you are alarmed by the number or severity of your seizure episodes.
• If you are alarmed by the color or breathing of the patient.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abnormal thinking

agitation

anxiety

black, tarry, stools

blurred vision

chest pain or discomfort

chills

cold, clammy, pale skin

confusion

cough

crying

delusions of persecution, mistrust, suspiciousness, or combativeness

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

false or unusual sense of well-being

feeling of constant movement of self or surroundings

feeling of unreality

feeling of warmth or heat

fever

flushing or redness of the skin, especially on the face and neck

headache

hyperexcitability

irregular heartbeat

lower back or side pain

mental depression

outbursts of anger

painful or difficult urination

pale skin

quick to react or overreact emotionally

rapidly changing moods

seeing, hearing, or feeling things that are not there

seizures

sensation of spinning

sense of detachment from self or body

slow or irregular heartbeat

slurred speech

sore throat

sweating

trouble with breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

change in consciousness

changes in patterns and rhythms of speech

confusion

difficult or trouble breathing

excitement

irregular, fast or slow, or shallow breathing

irritability

lack of coordination

loss of consciousness

loss of strength or energy

muscle pain or weakness

pale or blue lips, fingernails, or skin

restlessness

shakiness and unsteady walk

sleepiness or unusual drowsiness

slurred speech

talkativeness

trouble in speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual weak feeling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nasal discomfort

Less common

Changes in libido

changes in patterns and rhythms of speech

decrease in frequency of urination

difficulty in passing urine (dribbling)

difficulty in speaking

hiccup

increased muscle spasms

lack or loss of strength

loss of or change in taste

nosebleed

stuffy nose

trouble sleeping

uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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