Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. Valtoco

Descriptions


Diazepam nasal spray is used as short-term treatment for seizure clusters (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.

This product is available in the following dosage forms:

  • Spray

Before Using

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.

Pediatric

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.

Geriatric

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.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

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
  • Amobarbital
  • Benzhydrocodone
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcifediol
  • Calcium Oxybate
  • Cannabidiol
  • Carbinoxamine
  • Carisoprodol
  • Cetirizine
  • Chloral Hydrate
  • Chlorzoxazone
  • Clobazam
  • Cobicistat
  • Codeine
  • Conivaptan
  • Dantrolene
  • Dihydrocodeine
  • Doxylamine
  • Esketamine
  • Eslicarbazepine Acetate
  • Ethchlorvynol
  • Etravirine
  • Fentanyl
  • Flibanserin
  • Fosnetupitant
  • Fosphenytoin
  • Fospropofol
  • Gabapentin
  • Gabapentin Enacarbil
  • Hydrocodone
  • Hydromorphone
  • Ketamine
  • Lemborexant
  • Levorphanol
  • Lofexidine
  • Loxapine
  • Magnesium Oxybate
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Netupitant
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Phenytoin
  • Potassium Oxybate
  • Pregabalin
  • Primidone
  • Propofol
  • Remimazolam
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Thiopental
  • Tramadol
  • Trazodone
  • Zolpidem

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
  • Fluvoxamine
  • 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.

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 abuse, or history of or
  • Depression, or history of or
  • Drug abuse or dependence, history of or
  • Lung or breathing problems (including asthma, emphysema, bronchitis, COPD) or
  • Mental health problems, or history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. May increase risk for more side effects.
  • Narrow-angle glaucoma—Should not be used in patients with this condition.

Proper Use

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.

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

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.

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 troubled 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.

Diazepam nasal spray 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, such as 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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

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.

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

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

  1. Abnormal thinking
  2. agitation
  3. anxiety
  4. black, tarry, stools
  5. blurred vision
  6. chest pain or discomfort
  7. chills
  8. cold, clammy, pale skin
  9. confusion
  10. cough
  11. crying
  12. delusions of persecution, mistrust, suspiciousness, or combativeness
  13. dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
  14. false or unusual sense of well-being
  15. feeling of constant movement of self or surroundings
  16. feeling of unreality
  17. feeling of warmth or heat
  18. fever
  19. flushing or redness of the skin, especially on the face and neck
  20. headache
  21. hyperexcitability
  22. irregular heartbeat
  23. lower back or side pain
  24. mental depression
  25. outbursts of anger
  26. painful or difficult urination
  27. pale skin
  28. quick to react or overreact emotionally
  29. rapidly changing moods
  30. seeing, hearing, or feeling things that are not there
  31. seizures
  32. sensation of spinning
  33. sense of detachment from self or body
  34. slow or irregular heartbeat
  35. slurred speech
  36. sore throat
  37. sweating
  38. trouble with breathing
  39. ulcers, sores, or white spots in the mouth
  40. unusual bleeding or bruising
  41. unusual tiredness or weakness
  42. yellow eyes or skin

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

  1. Nasal discomfort

Less common

  1. Changes in libido
  2. changes in patterns and rhythms of speech
  3. decrease in frequency of urination
  4. difficulty in passing urine (dribbling)
  5. difficulty in speaking
  6. hiccup
  7. increased muscle spasms
  8. lack or loss of strength
  9. loss of or change in taste
  10. nosebleed
  11. stuffy nose
  12. trouble sleeping
  13. 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.