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Drug Interactions between clobazam and Diacomit

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

cloBAZam stiripentol

Applies to: clobazam and Diacomit (stiripentol)

ADJUST DOSE: Coadministration with stiripentol may significantly increase the plasma concentrations of clobazam and its pharmacologically active metabolite, norclobazam. The proposed mechanism is stiripentol inhibition of CYP450 3A4 and CYP450 2C19, the isoenzymes responsible for the metabolic clearance of clobazam and norclobazam, respectively. In pediatric patients, addition of stiripentol to clobazam increased plasma concentrations of clobazam by 2- to 3-fold and norclobazam by 5-fold. Although stiripentol is approved for use with clobazam in the treatment of Dravet syndrome, concomitant use may increase clobazam-related adverse effects such as somnolence and impairment of judgment, thinking, and psychomotor skills. Clobazam does not appear to significantly affect the pharmacokinetics of stiripentol. An average increase of 25% in stiripentol concentration has been reported during coadministration with clobazam in a retrospective analysis of 220 stiripentol concentrations from 75 patients.

MANAGEMENT: Patients should be closely monitored for clobazam adverse effects, particularly somnolence, during coadministration with stiripentol. A dosage reduction of clobazam by 25% should be considered upon onset of side effects, followed by additional reductions of 25% if side effects persist. In clinical studies, the daily dosage of clobazam was decreased by 25% every week in subjects who exhibited side effects or signs of excessive dosage such as drowsiness, hypotonia, and irritability (in young children). Adjustment of other concomitant anticonvulsant drugs with sedating properties may also be required. Patients should be counseled to avoid hazardous activities requiring mental alertness and motor coordination until they know how these agents affect them.

References (4)
  1. Giraud C, Treluyer JM, Rey E, et al. (2006) "In vitro and in vivo inhibitory effect of stiripentol on clobazam metabolism." Drug Metab Dispos, 34, p. 608-11
  2. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
  3. May TW, Boor R, Mayer T, et al. (2012) "Concentrations of stiripentol in children and adults with epilepsy: the influence of dose, age, and comedication." Ther Drug Monit, 34, p. 390-7
  4. (2018) "Product Information. Diacomit (stiripentol)." Biocodex USA

Drug and food interactions

Moderate

cloBAZam food

Applies to: clobazam

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

References (4)
  1. Warrington SJ, Ankier SI, Turner P (1986) "Evaluation of possible interactions between ethanol and trazodone or amitriptyline." Neuropsychobiology, 15, p. 31-7
  2. Gilman AG, eds., Nies AS, Rall TW, Taylor P (1990) "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc.
  3. (2012) "Product Information. Fycompa (perampanel)." Eisai Inc
  4. (2015) "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc
Moderate

stiripentol food

Applies to: Diacomit (stiripentol)

GENERALLY AVOID: Taking stiripentol on an empty stomach may reduce its oral bioavailability. Stiripentol degrades rapidly when exposed to gastric acid in an empty stomach.

GENERALLY AVOID: Alcohol may potentiate the depressant effects of stiripentol on the central nervous system. Concomitant use may result in increased sedation and dizziness as well as impairment of psychomotor skills.

GENERALLY AVOID: It is not known whether stiripentol may reduce theophylline and caffeine metabolism, as data on the potential for inhibition of CYP450 1A2 are limited. Consumption of foods and nutritional products such as cola drinks (which contain significant quantities of caffeine) and chocolate (which contains caffeine and trace amounts of theophylline) may be unsafe during treatment with stiripentol, particularly in children.

MANAGEMENT: Stiripentol should be taken during a meal for optimal absorption; however, it should not be taken with milk, dairy products (e.g., yogurt, soft cream cheese), fruit juice, or carbonated beverages. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them. Food and beverages that may contain caffeine or theophylline such as colas, chocolate, coffee, tea, or energy drinks should also be avoided during treatment with stiripentol.

References (3)
  1. Canadian Pharmacists Association (2006) e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink
  2. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
  3. (2018) "Product Information. Diacomit (stiripentol)." Biocodex USA

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


Report options

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.