Names and pronunciation
Kloe′ba-zam Onfi, Sympazam
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Drug reference
Kloe′ba-zam Onfi, Sympazam
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Func. class.: Anticoagulant
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Chem. class.: Benzodiazepine Controlled Substance Schedule IV
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ACTION: Potentates the GABA system by binding at the benzodiazepine site
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USES: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
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CONTRAINDICATIONS: Hyper- sensitivity, breastfeeding Precautions: Abrupt discontinuation, dependency, drug abuse, depression, sui- cidal thoughts/behaviors, CNS depres- sants, opiates
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SIDE EFFECTS CNS: Fatigue, sedation, hyperactivity, insomnia, lethargy GI: Vomiting, nausea, constipation GU: UTI META: Increased/decreased appetite RESP: URI, pneumonia, cough
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INTERACTIONS Increase: sedation: CNS depressants, avoid using together Increase: sedation, respiratory depres- sion: opioids Increase: clobazam effect: CYP2C19 inhibitors, alcohol Decrease: effect of hormonal contra- ceptives, use alternative contraception
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DOSAGE AND ROUTES • Adult and child ≥2 yr and >30 kg: PO 5 mg bid × 6 days; on day 7, increase to 10 bid; on day 14, increase to 20 mg bid as needed, max 40 mg/day • Adult and child ≥2 yr and <30 kg: PO 5 mg daily × 6 days, then day 7 increase to 5 mg bid, then day 14 in- crease to 10 mg bid as tolerated, max 40 mg/day Hepatic dose, poor CYP2C19 metab- olizers, elderly • Adult: PO 5 mg daily × 7 days, then titrate to half the recommended dose
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Available forms: Tablets 10, 20 mg; oral suspension 2.5 mg/mL; oral film 5 mg, 10 mg, 20 mg
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Administer: • May crush, break and give with soft food, may give without regard to food • Shake oral suspension prior to use • Apply oral film to tongue immediately after opening, do not use with liquids • Not to discontinue abruptly, taper on weekly basis by 10 mg
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Assess: • Hypersensitive reactions, and Stevens-Johnson syndrome, toxic epi- dermal necrolysis: rashes, blistering/ swelling of mouth, may occur anytime, but more common during the first 2 mo of use • Suicidal thoughts/behaviors: mon- itor for depression, change in behaviors, thoughts, mood • Opioids, CNS depression use: mon- itor for severe respiratory depression, avoid using together; monitor for abuse, dependence • Pregnancy/breastfeeding: to avoid use in pregnancy, if pregnant, enroll in North American AED Pregnancy Registry (888-238-2334), not to breastfeed
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Evaluate: • Therapeutic response: decreasing sei- zures without serious reactions Patient/family teaching: • To use caution in driving, other haz- ardous activities until response is known • To discuss with providers the use of this product and all others taken • Pregnancy/breastfeeding: to report if pregnancy is planned or suspected, or if breastfeeding or if using hormonal con- traceptives, use alternative contraceptive • How to use suspension and film • Not to use suspension after 90 days, discard • Suicidal thoughts/behaviors: to have patient or family members, caregivers to report suicidal thought/behaviors, depres- sion, change in mood • Not to discontinue abruptly
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CLINICAL CONSIDERATIONS
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PHARMACOKINETICS Onset rapid, peak 1-4 hr, duration unknown, half-life 36-82 hr
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• Adult and child ≥2 yr and >30 kg: PO 5 mg bid × 6 days; on day 7, increase to 10 bid; on day 14, increase to 20 mg bid as needed, max 40 mg/day
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• Adult and child ≥2 yr and <30 kg: PO 5 mg daily × 6 days, then day 7 increase to 5 mg bid, then day 14 in- crease to 10 mg bid as tolerated, max 40 mg/day Hepatic dose, poor CYP2C19 metab- olizers, elderly
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• Adult: PO 5 mg daily × 7 days, then titrate to half the recommended dose
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