Monograph Details

Central Nervous System > Seizure disorders
DIASTAT
Manufacturer
Valeant Pharmaceuticals, Inc
Legal Classification
CIV
Pharmacological Class
Benzodiazepine.
Generic Name
Diazepam 2.5mg, 5mg, 10mg, 15mg, 20mg; per applicator; rectal gel.
Indications
Intermittent use in epilepsy to control bouts of increased seizure activity.
Adults and Children
Individualize dose. Calculate dose based on body weight (in kg) and round up to next available dosage strength; do not subdivide fixed-dose products. Treat no more than 1 episode every 5 days and no more than 5 episodes per month. See literature for dosing chart. <2 years: not recommended. 2–5 yrs: 0.5mg/kg. 6–11 yrs: 0.3mg/kg. ≥12 yrs: 0.2mg/kg. Elderly or debilitated: reduce dose. May give 2nd dose 4–12 hrs after 1st dose. May use 2.5mg strength as supplemental dose.
Contraindications
Acute narrow-angle glaucoma.
Precautions
See literature. 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. Not for use in untreated open-angle glaucoma. Renal or hepatic impairment. Compromised respiratory function. Avoid abrupt cessation. Drug or alcohol abuse. Chronic use of diazepam may increase tonic-clonic seizures. Elderly. Pregnancy (Cat.D), labor & delivery, nursing mothers: not recommended.
Interactions
CNS depression potentiated with valproate, alcohol, other CNS depressants. Caution with other psychotropics. Potentiated by sertraline. May be potentiated by inhibitors of CYP2C19 or CYP3A4 activity or antagonized by inducers of these enzymes. Diazepam may potentiate or antagonize other drugs metabolized by these enzymes.
Adverse Reactions
Somnolence, dizziness, headache, pain, nervousness, vasodilation, diarrhea, ataxia, euphoria, incoordination, asthma, rhinitis, rash, hyperkinesia, hypoventilation, paradoxical excitement.
How Supplied
2.5mg, 5mg, 10mg (pediatric applicator)—2 (w. lubricant)
10mg, 15mg, 20mg (adult applicator)—2 (w. lubricant)
Additional Resources
Related Prescribing Note