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Valtoco
diazepam nasal
Black Box Warnings .
Risks from Concomitant Opioid Use
concomitant benzodiazepine use w/ opioids may result in profound sedation, resp. depression, coma, and death; reserve concomitant use for patients w/ inadequate alternative tx options; limit to minimum required dosage and duration; monitor patients for signs/symptoms of resp. depression and sedation
Addiction, Abuse, and Misuse
benzodiazepines expose users to risk of abuse, misuse, and addiction, can lead to overdose or death; commonly involves concomitant use w/ other meds, alcohol, and/or illicit substances, which is associated w/ incr. frequency of serious adverse outcomes; assess risk for abuse, misuse, and addiction before prescribing and throughout tx
Dependence and Withdrawal Reactions
continuous benzodiazepine use may lead to clinically significant physical dependence; risk of dependence and withdrawal incr. w/ longer tx duration and higher daily dose; if used more frequently than recommended, use gradual taper to D/C as abrupt D/C or rapid dose reduction may cause acute withdrawal reactions, potentially life-threatening
Adult Dosing .
Dosage forms: SPRAY: 5 mg, 10 mg; SPRAY (15 mg dose pack): 7.5 mg x2; SPRAY (20 mg dose pack): 10 mg x2
Special Note
- [dosing clarification]
- Info: each device delivers 1 spray
seizures, acute repetitive
- [14-27 kg]
- Dose: 5 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [28-50 kg]
- Dose: 10 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [51-75 kg]
- Dose: 15 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [>76 kg]
- Dose: 20 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: SPRAY: 5 mg, 10 mg; SPRAY (15 mg dose pack): 7.5 mg x2; SPRAY (20 mg dose pack): 10 mg x2
Special Note
- [dosing clarification]
- Info: each device delivers 1 spray
seizures, acute repetitive
- [2-5 yo, 6-11 kg]
- Dose: 5 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [2-5 yo, 12-22 kg]
- Dose: 10 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [2-5 yo, 23-33 kg]
- Dose: 15 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [6-11 yo, 10-18 kg]
- Dose: 5 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [6-11 yo, 19-37 kg]
- Dose: 10 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [6-11 yo, 38-55 kg]
- Dose: 15 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [6-11 yo, 56-74 kg]
- Dose: 20 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [12 yo and older, 14-27 kg]
- Dose: 5 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [12 yo and older, 28-50 kg]
- Dose: 10 mg intranasally x1 given as 1 spray in one nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [12 yo and older, 51-75 kg]
- Dose: 15 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
- [12 yo and older, >76 kg]
- Dose: 20 mg intranasally x1 given as 1 spray in each nostril, then may repeat dose x1 after at least 4h; Max: 2 doses/single episode; 1 episode q5 days for up to 5 episodes/mo; Info: alternate nostrils w/ each spray
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- angle-closure glaucoma, acute
- caution: glaucoma, open-angle
- caution: hypersensitivity to benzodiazepines
- caution: children
- caution: elderly patients
- caution: debilitated patients
- caution: hepatic impairment
- caution: pulmonary impairment
- caution: CNS depression
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: alcohol abuse history
- caution: drug abuse history
- caution: suicide risk
- caution: depression
Drug Interactions .
Overview
diazepam
benzodiazepine
- CYP2C19 substrate
- CYP3A4 substrate
- affected by altered fat absorption
- antiepileptic agent
- CNS depression
- hypotensive effects
Contraindicated
- amifampridine
- bupropion
- dalfampridine
Avoid/Use Alternative
- alfentanil
- alprazolam
- aripiprazole lauroxil
- baclofen intrathecal
- buprenorphine
- butalbital
- butorphanol
- chlordiazepoxide
- clobazam
- clonazepam
- clonidine
- clorazepate
- codeine
- desflurane
- dexmedetomidine injection
- diazepam
- dihydrocodeine
- doxylamine
- estazolam
- ethanol
- ethanol (in some formulations)
- fentanyl
- flurazepam
- fluvoxamine
- gabapentin
- gabapentin enacarbil
- ginkgo
- grapefruit
- haloperidol
- hydrocodone
- hydromorphone
- isocarboxazid
- isoflurane
- kava
- ketamine
- kratom
- levorphanol
- lorazepam
- meperidine
- metaxalone
- methadone
- methohexital
- metoclopramide
- midazolam
- morphine
- nalbuphine
- olanzapine
- oliceridine
- opium
- oxazepam
- oxybate
- oxycodone
- oxymorphone
- paliperidone
- pentazocine
- pentobarbital
- phenelzine
- phenobarbital
- pregabalin
- primidone
- promethazine
- propofol
- quazepam
- remifentanil
- remimazolam
- ropeginterferon alfa-2b
- sufentanil
- tapentadol
- temazepam
- thalidomide
- tramadol
- tranylcypromine
- triazolam
- zuranolone
Monitor/Modify Tx
- 5-HTP
- adagrasib
- aldesleukin
- allopurinol
- almotriptan
- amantadine
- amitriptyline
- amoxapine
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole monthly injection
- aripiprazole oral
- armodafinil
- asenapine
- atazanavir
- baclofen
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- bromocriptine
- brompheniramine
- buspirone
- cannabidiol
- cannabis
- carbamazepine
- carbinoxamine
- cariprazine
- carisoprodol
- cenobamate
- ceritinib
- cetirizine
- chamomile, German
- chlophedianol
- chloramphenicol
- chlorcyclizine
- chlorpheniramine
- chlorpromazine
- chlorzoxazone
- cimetidine
- citalopram
- clarithromycin
- clemastine
- clomipramine
- clopidogrel
- clozapine
- cobicistat
- cyclobenzaprine
- cyproheptadine
- dantrolene
- daridorexant
- darifenacin
- darunavir
- desipramine
- desvenlafaxine
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dexmedetomidine
- dichlorphenamide
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- domperidone
- doxepin
- doxepin topical
- dronabinol
- droperidol
- duloxetine
- efavirenz
- elagolix
- eletriptan
- elinzanetant
- enasidenib
- entacapone
- entrectinib
- escitalopram
- esketamine
- eslicarbazepine acetate
- esomeprazole
- estradiol (contraceptive)
- eszopiclone
- ethinyl estradiol (contraceptive)
- ethosuximide
- etomidate
- etravirine
- fedratinib
- felbamate
- fenfluramine
- fesoterodine
- fexinidazole
- flibanserin
- fluconazole
- fluoxetine
- fluphenazine
- foslevodopa
- fosphenytoin
- frovatriptan
- ganaxolone
- garlic
- givosiran
- glofitamab
- glycopyrrolate
- guanfacine
- hydroxyzine
- hyoscyamine
- idelalisib
- ifosfamide
- iloperidone
- imipramine
- isoniazid
- itraconazole
- ketoconazole
- lacosamide
- lamotrigine
- lasmiditan
- lemborexant
- levetiracetam
- levocetirizine
- levodopa
- levoketoconazole
- levomilnacipran
- linvoseltamab
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- loxapine
- luliconazole topical
- lumateperone
- lurasidone
- meclizine
- melatonin
- meprobamate
- methocarbamol
- methsuximide
- methyldopa
- metyrapone
- metyrosine
- mifepristone
- milnacipran
- mirtazapine
- mitotane
- modafinil
- molindone
- mosunetuzumab
- mycophenolate mofetil
- naltrexone
- naratriptan
- nefazodone
- nelarabine
- nelfinavir
- nortriptyline
- omeprazole
- opicapone
- orphenadrine
- osilodrostat
- oxcarbazepine
- oxybutynin
- paroxetine
- passion flower
- perampanel
- perphenazine
- pheniramine
- phenylephrine injection
- phenytoin
- pimozide
- pirtobrutinib
- posaconazole
- pramipexole
- procarbazine
- prochlorperazine
- propranolol
- protriptyline
- pyrilamine
- quetiapine
- ramelteon
- rasagiline
- repotrectinib
- ribociclib
- risperidone
- ritonavir
- rizatriptan
- ropinirole
- rotigotine transdermal
- rucaparib
- rufinamide
- safinamide
- scopolamine
- selegiline
- selegiline transdermal
- selinexor
- sertraline
- sevoflurane
- solifenacin
- stiripentol
- sumatriptan
- suvorexant
- tasimelteon
- tecovirimat
- tetrabenazine
- thioridazine
- thiotepa
- thiothixene
- tiagabine
- tipranavir
- tizanidine
- tolcapone
- tolterodine
- topiramate
- trazodone
- treosulfan
- triclabendazole
- trifluoperazine
- trihexyphenidyl
- trimethobenzamide
- trimipramine
- triprolidine
- trospium
- tucatinib
- valbenazine
- valerian
- valproic acid
- venlafaxine
- vigabatrin
- vilazodone
- viloxazine
- vonoprazan
- voriconazole
- zaleplon
- ziconotide
- ziprasidone
- zolmitriptan
- zolpidem
- zonisamide
Therapeutic Advantage
- flumazenil
Caution Advised
- acyclovir
- aminophylline
- amoxicillin
- amphetamine
- ampicillin
- apalutamide
- axicabtagene ciloleucel
- benzphetamine
- betamethasone
- bosentan
- brexucabtagene autoleucel
- busulfan
- cefazolin
- cefepime
- cefiderocol
- ceftaroline
- ceftazidime
- ceftobiprole
- chlorambucil
- chloroquine
- ciltacabtagene autoleucel
- ciprofloxacin
- cisatracurium
- cocaine
- cortisone
- cycloserine
- cyclosporine
- dabrafenib
- darbepoetin alfa
- darolutamide
- deflazacort
- delafloxacin
- dexamethasone
- dexmethylphenidate
- dextroamphetamine
- dicloxacillin
- diethylpropion
- donepezil
- elivaldogene autotemcel
- encorafenib
- enzalutamide
- ephedra
- epoetin alfa
- ertapenem
- foscarnet
- galantamine
- ganciclovir
- goserelin
- histrelin
- hydroxychloroquine
- idecabtagene vicleucel
- imipenem
- interferon beta 1a
- interferon beta 1b
- iohexol
- iopamidol
- ivosidenib
- ketorolac
- leuprolide
- levocarnitine
- levofloxacin
- lidocaine
- lidocaine topical
- linezolid
- lisdexamfetamine
- lisocabtagene maraleucel
- lithium
- lorlatinib
- lumacaftor/ivacaftor
- magnesium citrate
- mavacamten
- mefloquine
- meropenem
- methamphetamine
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methylphenidate
- metronidazole
- mexiletine
- mitapivat
- moxifloxacin
- nafarelin nasal
- nafcillin
- obecabtagene autoleucel
- ofloxacin
- oxacillin
- pacritinib
- peginterferon beta 1a
- penicillin G
- penicillin V
- pexidartinib
- phendimetrazine
- phentermine
- piperacillin
- polyethylene glycol
- polyethylene glycol/electrolytes
- pyridostigmine
- pyrimethamine
- quinine
- raloxifene
- regadenoson
- rifabutin
- rifampin
- rifapentine
- rivastigmine
- sodium picosulfate
- sotorasib
- St. John's wort
- sulfate bowel prep
- tacrolimus
- teclistamab
- terbutaline
- theophylline
- tinidazole
- tisagenlecleucel
- tranexamic acid
- triamcinolone
- triptorelin
- vadadustat
- valacyclovir
- valganciclovir
- varenicline
Adverse Reactions .
Serious Reactions
- respiratory depression
- dependency
- abuse
- seizures
- suicidality
- bradycardia
- hypotension, severe
- syncope
- cardiovascular collapse
- neutropenia
- jaundice
- CNS stimulation, paradoxical
Common Reactions
- somnolence
- nasal discomfort
- headache
- diarrhea
- euphoria
- rash
- ataxia
- dizziness
- psychomotor impairment
- dysgeusia
- epistaxis
- vasodilation
- asthma
Safety/Monitoring .
Monitoring Parameters
signs/symptoms of depression, behavior changes, suicidality
Look/Sound-Alike Drug Names
diazePAM confused with: ALPRAZolam; clonazePAM; DiaBeta; dilTIAZem; Ditropan; Ditropan XL; doxepin; LORazepam; midazolam; oxazepam; temazepam
Benzyl Alcohol Content
contains 10.5 mg benzyl alcohol per 0.1 mL; risk of serious, potentially fatal gasping syndrome in neonates and low-birth wt infants receiving benzyl alcohol-containing drugs; not approved in patients <2 yo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; possible risk of teratogenicity based on conflicting human data w/ benzodiazepine class; risk of neonatal respiratory depression, hypotonia, sedation, and withdrawal symptoms w/ near term use based on human data w/ benzodiazepine class
Pregnancy Registry
encourage patients to enroll in North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334 or www.aedpregnancyregistry.org
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; possible risk of infant CNS depression based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for diazepam: liver extensively; CYP450: 2C19, 3A4 substrate; Info: 97% systemic absorption; active metabolites include minor metabolites (temazepam, oxazepam)
Excretion: for diazepam: urine; Half-life: 49.2h
Subclass: Benzodiazepines (BZDs), Long-acting ; Seizure Disorders
Mechanism of Action
for diazepam: binds to benzodiazepine receptors; enhances GABA effects
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Neurelis, Inc.
DEA/FDA: Schedule IV
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
nasal spray:
- 5 mg (1 carton, 2 nasal spray devices): $609.00
- 10 mg (1 carton, 2 nasal spray devices): $609.00
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