Whereas misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.In the clinical studies with VALTOCO at recommended doses, abuse-related adverse events included euphoria, somnolence, sedation, anterograde amnesia, depression, anxiety, hallucinations, and restlessness.Abuse and misuse of diazepam products, especially prolonged and at higher doses, may result in neuropsychiatric and other symptoms including: euphoria, anxiety, depression, irritability, restlessness, cognitive and psychomotor impairment, disorientation, paranoia, hallucinations, slurred speech, double vision, tremors, nausea or vomiting, loss of appetite, and muscle spasms.Both tolerance and physical dependence can develop during chronic or frequent use of diazepam products. During Two weeks I had another blackout. Muscle Spasm You can ask your pharmacist or healthcare provider for information about VALTOCO that is written for health professionals.You and your family members, caregivers, and others who may need to administer VALTOCO should read this Instructions for Use that comes with VALTOCO before using it. If the second dose is to be administered, use a new blister pack of VALTOCO.Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of VALTOCO to treat a single episode.It is recommended that VALTOCO be used to treat no more than one episode every five days and no more than five episodes per month.No device assembly is required. Just one dose can cause death in someone using Valium accidentally or improperly. The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans.There are no data to assess the effects of VALTOCO and/or its active metabolite(s) on the breastfed infant or on milk production. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists [seeCoadministration of other CNS depressants (e.g., valproate) or consumption of alcohol may potentiate the CNS-depressant effects of diazepam [see Potential interactions may occur when diazepam is given concurrently with agents that affect CYP2C19 and CYP3A4 activity.Inhibitors of CYP2C19 (e.g., cimetidine, quinidine, and tranylcypromine) and CYP3A4 (e.g., ketoconazole, troleandomycin, and clotrimazole) could decrease the rate of diazepam elimination; therefore, adverse reactions to VALTOCO may be increased.Inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone, and phenobarbital) could increase the rate of diazepam elimination; therefore, efficacy of VALTOCO may be decreased.Diazepam is a substrate for CYP2C19 and CYP3A4; therefore, it is possible that VALTOCO may interfere with the metabolism of drugs which are substrates for CYP2C19 (e.g., omeprazole, propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, terfenadine, theophylline, and warfarin) leading to a potential drug-drug interaction.Concomitant use of benzodiazepines, including VALTOCO, and opioids may result in profound sedation, respiratory depression, coma, and death [seeObservational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. ), NS(?) Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. The estimated volume of distribution of diazepam at steady-state is 0.8 to 1.0 L/kg. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvdmFsaXVtLWRpYXN0YXQtZGlhemVwYW0tMzQyOTAy You may report side effects to FDA at 1-800-FDA-1088.The inactive ingredients in VALTOCO nasal spray include benzyl alcohol (10.5 mg per 0.1 mL), dehydrated alcohol, n-dodecyl beta-D-maltoside, and vitamin E. VALTOCO nasal spray is a clear pale amber liquid.VALTOCO® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.Prior to treatment, healthcare professionals should instruct the individual administering VALTOCO on how to identify seizure clusters and use the product appropriately [see The recommended dose of VALTOCO nasal spray is 0.2 mg/kg or 0.3 mg/kg, depending on the patient’s age and weight. published a meta-analysis of 23 studies that examined the effects of benzodiazepine exposure during the first trimester of pregnancy. Do not use VALTOCO for more than 1 seizure cluster episode every 5 days.

The metabolism of diazepam is primarily hepatic and involves demethylation (involving primarily CYP2C19 and CYP3A4) and 3-hydroxylation (involving primarily CYP3A4), followed by glucuronidation.