Lucius LuciStir Stiripentol 250mg

Product Information

• Product name: LuciStir Stiripentol 250mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Stiripentol
• Current strength: 250mg
• SKU: LU-ITEM-111
• Site category: other cancer

Product Summary

LuciStir Stiripentol 250mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Stiripentol is the active ingredient used for this product page. Public prescribing information for Stiripentol was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

The mechanism by which Stiripentol exerts its anticonvulsant effect in humans is unknown. Possible mechanisms of action include direct effects mediated through the gamma-aminobutyric acid (GABA) A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and its active metabolite.

Reference Indications

Stiripentol is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of Stiripentol as monotherapy in Dravet syndrome. Stiripentol is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more . There are no clinical data to support the use of Stiripentol as monotherapy in Dravet syndrome.

Reference Dosage and Administration

Recommended Dosage for Patients 6 Months of Age and Older Weighing 7 kg or More with Dravet Syndrome Age of Patient Body Weight Dosing Regimen (administered by mouth in equally divided doses) Total Daily Dose 6 months to less than 1 year 7 kg and above 25 mg/kg twice daily a,b 50 mg/kg/day 1 year and above 7 kg to less than 10 kg 25 mg/kg twice daily b 50 mg/kg/day 10 kg and above 25 mg/kg twice daily or 16. administered by mouth in 2 or 3 divided doses, depending on age and weight.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Somnolence: Monitor for somnolence, particularly when Stiripentol is used concomitantly with other CNS depressants; If somnolence occurs during co-administration with clobazam, consider an initial reduction of clobazam by 25%. Decreased Appetite and Decreased Weight: the weight of patients and the growth rate of pediatric patients should be carefully monitored. Neutropenia and Thrombocytopenia: Blood counts should be obtained prior to starting treatment with Stiripentol and then every 6 months. Withdrawal : Stiripentol should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. Risks in Patients with Phenylketonuria (PKU) : Stiripentol for oral suspension contains phenylalanine; consider total daily intake before prescribing to patients with PKU.

Common Adverse Reactions and Monitoring

During its development for the treatment of seizures associated with Dravet syndrome, Stiripentol was administered to 55 healthy male volunteers and 438 patients with Dravet syndrome, including 310 patients treated for 12 months or more. Approximately 53% of patients were female and the mean age was 9.2 years. All patients were taking clobazam and valproate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and infestations: Pneumonia

Drug Interactions and Special Populations

Stiripentol increases the plasma concentration of clobazam and its metabolite through metabolic inhibition of CYP3A4 and CYP2C19. Substrates of CYP2C8, CYP2C19, P-gp and BCRP may require a dose reduction. Substrates of CYP1A2, CYP2B6 and CYP3A4 may require a dose adjustment. Strong inducers of CYP1A2, CYP3A4 or CYP2C19: Consider dose increase of Stiripentol. Clobazam Co-administration of Stiripentol (which inhibits CYP 3A4 and 2C19) with clobazam results in increased plasma concentrations of clobazam (a substrate of CYP3A4) and norclobazam, the active metabolite of clobazam (a substrate of CYP2C19) . Concomitant use of strong inducers with Stiripentol should be avoided, or dosage adjustments should be made. Pregnancy: Based on animal data, may cause fetal harm.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Diacomit public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.