SYMPAZAN

SYMPAZAN ® Oral Films at single doses of 10 mg and 20 mg clobazam have been shown to be bioequivalent (C m a x and AUC) to clobazam tablets at equivalent doses. Following single-dose administration of SYMPAZAN ® , peak plasma levels (C max ) and the area under the curve (AUC) of clobazam are dose-proportional over the dose range of 10-20 mg. Based on a population pharmacokinetic analysis with clobazam tablets, the pharmacokinetics of clobazam are linear from 5-160 mg/day. Clobazam is converted t...

Figure 1: Mean Percent Reduction from Baseline in Weekly Drop Seizure Frequency (Study 1) Figure 2: Drop Seizure Response by Category for Clobazam and Placebo (Study 1) 14.1 Demonstration of Pharmacokinetic Equivalence Between SYMPAZAN ® and Clobazam Tablets The efficacy of SYMPAZAN ® is based upon bioavailability studies comparing clobazam tablets to SYMPAZAN ® [see Clinical Pharmacology (12.3) ]. 14.2 Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS) The effectiveness of clobazam for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome was...

Clinically significant adverse reactions that appear in other sections of the labeling include the following: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] Dependence and Withdrawal Reactions [see Warnings and Precautions (5.3) ] Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants [see Warnings and Precautions (5.4) ] Somnolence or Sedation [see Warnings and Precau...

SYMPAZAN ® is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions [see Warnings and Precautions (5.6) ]. History of hypersensitivity to the drug or its ingredients ( 4 )

Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants ( 5.4 , 5.5 ) Serious Dermatological Reactions (including Stevens-Johnson Syndrome and toxic epidermal necrolysis): Discontinue SYMPAZAN ® at first sign of rash unless the rash is clearly not drug-related ( 5.6 ) Drug Reaction with Eosinophilia and Systemic Symptoms (Dress)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology ( 5.7 ) Suic...

7 DRUG INTERACTIONS Alcohol: Increases blood levels of clobazam by about 50% ( 7.2 ) Drugs metabolized by CYP2D6: Lower doses of these drugs may be required when used concomitantly with SYMPAZAN ® ( 7.3 ) Strong or Moderate CYP2C19 Inhibitors: Dosage adjustment of SYMPAZAN ® may be necessary ( 7.4 ) Cannabidiol: May increase risk of SYMPAZAN-related adverse reactions; consider dosage adjustment if...