Indications for VALTOCO:
Acute treatment of intermittent, stereotypic episodes of seizure activity (eg, seizure clusters, acute repetitive seizures) that are distinct from usual seizure pattern.
Adults and Children:
For intranasal use only. Individualize. Calculate dose based on body weight (in kg) and round up to next available dosage strength. Treat no more than 1 episode every 5 days and no more than 5 episodes per month. <6yrs: not established. 6–11yrs: 0.3mg/kg. ≥12yrs: 0.2mg/kg. See full labeling for dosing chart. If needed, may give 2nd dose at least 4 hours after 1st dose. Max 2 doses/episode. Elderly: reduce dose.
Acute narrow-angle glaucoma.
Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.
Risks from concomitant use with opioids; see Interactions. Caregiver must be fully able to identify cluster seizures, be able to decide when to treat, correctly administer dose, monitor patient, and assess response. CNS depression. Monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes. Untreated open-angle glaucoma. Compromised respiratory function. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Drug or alcohol abusers. Renal or hepatic impairment. Elderly. Neonates or infants: not approved (contains benzyl alcohol). Pregnancy. Labor & delivery. Nursing mothers.
Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. CNS depression potentiated with alcohol, other CNS depressants (eg, valproate). Caution with other psychotropics. May be potentiated by inhibitors of CYP2C19 (eg, cimetidine, quinidine, tranylcypromine) or CYP3A4 (eg, ketoconazole, troleandomycin, clotrimazole). May be antagonized by inducers of CYP2C19 (eg, rifampin) or CYP3A4 (eg, carbamazepine, phenytoin, dexamethasone, phenobarbital). Diazepam may interfere with the metabolism of drugs which are substrates for CYP2C19 (eg, omeprazole, propranolol, imipramine) or CYP3A4 (eg, cyclosporine, paclitaxel, theophylline, warfarin).
Somnolence, headache, nasal discomfort; withdrawal reactions.
Generic Drug Availability:
Nasal spray 5mg—2; 7.5mg—4; 10mg—2, 4