Generic Name and Formulations:
Diazepam 2.5mg, 10mg, 20mg; per applicator; rectal gel.
Valeant Pharmaceuticals, Inc
Indications for DIASTAT:
Intermittent use in epilepsy to control bouts of increased seizure activity.
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.
Acute narrow-angle glaucoma.
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. Drug or alcohol abuse. Avoid abrupt cessation. Elderly. Neonates <6mos: not recommended. Pregnancy (Cat.D); avoid during the 1(sup>st trimester. Labor & delivery, nursing mothers: not recommended.
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).
Somnolence, dizziness, headache, pain, nervousness, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, rash, hyperkinesia, hypoventilation, paradoxical excitement (discontinue if occurs).
Gel delivery system—2 (w. applicator + lubricant)
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