Seizure disorders:
Indications for: DIASTAT
Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in those with epilepsy.
Adults and Children:
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. <2yrs: not established. 2–5yrs: 0.5mg/kg. 6–11yrs: 0.3mg/kg. ≥12yrs: 0.2mg/kg. See full labeling for dosing chart. Elderly or debilitated: reduce dose. May give 2nd dose 4–12hrs after 1st dose. May use 2.5mg strength as supplemental dose.
DIASTAT Contraindications:
Acute narrow-angle glaucoma.
Boxed Warning:
Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.
DIASTAT Warnings/Precautions:
Risks from concomitant use with opioids; see Interactions. Caregiver must be fully able to identify cluster seizures or prodrome, be able to decide when to treat, correctly administer rectal dose, monitor patient, and assess response. Monitor for CNS depressant effects. Untreated open-angle glaucoma. Renal or hepatic impairment. Compromised respiratory function. Neurologic damage. Chronic daily use of diazepam may increase tonic-clonic seizures; not recommended. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Drug or alcohol abusers. Elderly. Neonates <6mos: not recommended. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.
DIASTAT Classification:
Benzodiazepine.
DIASTAT Interactions:
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 valproate, alcohol, other CNS depressants. Caution with other psychotropics. May be potentiated by inhibitors of CYP2C19 (eg, cimetidine, quinidine) or CYP3A4 (eg, ketoconazole, troleandomycin, clotrimazole). May be antagonized by inducers of CYP2C19 (eg, rifampin) or CYP3A4 (eg, carbamazepine, phenytoin, dexamethasone, phenobarbital). Diazepam may potentiate or antagonize other drugs metabolized by these enzymes (eg, omeprazole, propranolol, imipramine, cyclosporine, paclitaxel, theophylline, warfarin).
Adverse Reactions:
Somnolence, dizziness, headache, pain, nervousness, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, rash, hyperkinesia, hypoventilation, paradoxical excitement (discontinue if occurs), withdrawal reactions.
Drug Elimination:
The mean elimination half-life of diazepam and desmethyldiazepam following administration of a 15 mg dose of diazepam rectal gel was found to be about 46 hours (CV=43%) and 71 hours (CV=37%), respectively.
Generic Drug Availability:
NO
How Supplied:
Gel delivery system—2 (w. applicator + lubricant)
