Diazepam Intranasal

Diazepam Intranasal is a prescription medication used to treat the symptoms of epilepsy.

• Diazepam Intranasal is available under the following different brand names: Valtoco

Common side effects of Diazepam Intranasal include:

• Drowsiness,
• Headache,
• Nasal discomfort,
• Diarrhea,
• Loss of coordination,
• Dizziness,
• Euphoria,
• Rash, and
• Asthma

Serious side effects of Diazepam Intranasal include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Slow breathing with long pauses,
• Blue-colored lips,
• Difficulty in waking up,
• Severe drowsiness,
• Unusual thoughts, and
• Light-headed feeling

Rare side effects of Diazepam Intranasal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intranasal spray: Schedule IV

• 5 mg/0.1 mL
• 7.5 mg/0.1 mL
• 10 mg/0.1 mL

Epilepsy

Adult and geriatric dosage

Adolescent or adult dose (0.2 mg/kg)

• 14-27 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
• 28-50 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
• 51-75 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
• Above 76 kg: 20 mg (two 10-mg devices); 1 spray in each nostril

Second dose and maximum dose

• Second dose: When required, may be administered at least 4 hours after the initial dose; if the second dose is to be administered, use a new blister pack of diazepam Intranasal
• Maximum dosage: Not to exceed 2 doses to treat a single episode
• Treatment frequency: Do not use for more than 1-episode every 5days and no more than 5 episodes per month

Pediatric dosage

• Below 6 years: Safety and efficacy not established
• 6-11 years (0.3 mg/kg)
  • 10-18 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
  • 19-37 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
  • 38-55 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
  • 56-74 kg: 20 mg (two 10-mg devices); 1 spray in each nostril
• 12 years or older (0.2 mg/kg)
  • 14-27 kg: 5 mg (one 5-mg device); 1 spray in 1 nostril
  • 28-50 kg: 10 mg (one 10-mg device); 1 spray in 1 nostril
  • 51-75 kg: 15 mg (two 7.5-mg devices); 1 spray in each nostril
  • Above 76 kg: 20 mg (two 10-mg devices); 1 spray in each nostril

Second dose and maximum dose

• Second dose: When required, may be administered at least 4 hr after the initial dose; if the second dose is to be administered, use a new blister pack of diazepam Intranasal
• Maximum dosage: Not to exceed 2 doses to treat a single episode
• Treatment frequency: Do not use for more than 1 episode q5days and no more than 5 episodes/month

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Diazepam Intranasal has severe interactions with no other drugs.
• Diazepam Intranasal has serious interactions with at least 37 other drugs.
• Diazepam Intranasal has moderate interactions with at least 198 other drugs.
• Diazepam Intranasal has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Acute narrow-angle glaucoma

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diazepam Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diazepam Intranasal?”

Cautions

• Benzodiazepines expose users to risks of abuse, misuse, and addiction, which can lead to overdose or death; abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death
• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death; because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for use in patients for whom alternative treatment options are inadequate
• Use of the drug, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of the drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency
• Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (. g, opioid analgesics, stimulants); advise patients on proper disposal of the unused drugs; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate
• For patients treated more frequently than recommended, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose), to reduce the risk of withdrawal reactions
• Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use
• In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months
• May produce CNS depression; caution patients against engaging in hazardous activities requiring mental alertness until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits
• Caution in patients with compromised respiratory function related to a concurrent disease process (.g, asthma, pneumonia) or neurologic damage
• Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor patients treated with any AED for any indication of the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
• Benzodiazepines can increase intraocular pressure in patients with glaucoma; may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy; diazepam is contraindicated in patients with narrow-angle glaucoma
• Not approved for use in neonates or infants; diazepam Intranasal contains benzyl alcohol, which can cause serious and fatal adverse reactions, including gasping syndrome, in neonates and low-birth-weight infants
• Drug interaction overview
• Diazepam is a CYP2C19 and CYP3A4 substrate
  • Coadministration of benzodiazepines and opioids increases the risk of respiratory depression; limit dosage and duration if concomitantly used; monitor closely for respiratory depression and sedation
  • Coadministration of other CNS depressants or alcohol consumption may potentiate CNS-depressant effects of diazepam
  • CYP2C19 or CYP3A4 inhibitors: May decrease the rate of diazepam elimination, thereby increasing adverse reactions to diazepam
  • CYP2C19 or CYP3A4 inducers: May increase the rate of diazepam elimination; therefore, the efficacy of diazepam may be decreased

Pregnancy and Lactation

• North American Antiepileptic Drug (NAAED) Pregnancy Registry: 1-888-233-2334; http://www.aedpregnancyregistry.org
• There are no adequate data on the use of diazepam Intranasal in pregnant women
• Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies
• Although some early epidemiological studies suggested a relationship between benzodiazepine use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations
• More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies
• There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment
• Neonatal withdrawal and floppy infant syndrome
• Neonatal withdrawal syndrome and symptoms suggestive of floppy infant syndrome associated with the administration of benzodiazepines during the later stages of pregnancy and peripartum period have been reported
• Lactation
  • Diazepam is excreted in human milk
  • There are no data specifically for diazepam Intranasal
  • Post-marketing experience suggests that breastfed infants of mothers taking benzodiazepines may have effects of lethargy, somnolence, and poor sucking