Diacomit

Stiripentol is a new anti-epileptic drug designed to treat rare and severe epilepsy.

Drug name

Common name: Stiripentol (stiripentol)

Trade name: DIACOMIT®

Indications

Indicated for the treatment of:

U200c in patients with Dravet syndrome 2 years old and above: needs to be used in combination with clobazam

U200c is not recommended: as a monotherapy for Dravet syndrome

Specifications and characteristics

Capsule :

250mg: pink, printed with "Diacomit" and "250mg"

500mg: white, printed with "Diac omit" and "500mg"

Oral suspension powder :

250mg/pack: light pink fruit-flavored powder

500mg/pack: light pink fruit-flavored powder

Main ingredients

Active ingredient: stiripentol

Excipients:

Capsules: gelatin, magnesium stearate, polyvinylpyrrolidone, etc.

Suspension: aspartame, sodium carboxymethylcellulose, glucose, etc.

Usage and dosage

Recommended dose :50mg/kg/day, taken in 2-3 times

Maximum dose :3000mg/day

Dose requirements : b>

Capsules: swallow whole, take with food, do not break or chew

Suspension: mix with 100mL of water and take immediately, take with food

Missed dose: take it as soon as possible, skip if it is close to the next dose time

Vomiting: no need to take it again

Dose adjustment

Drowsiness :Consider reducing clobazam dose by 25%

Diarrhea :

Grade 3 without anti-diarrheal treatment: suspend until recovery and continue at the original dose

Grade 3 with anti-diarrhea treatment: suspend until recovery and reduce Dosage

Grade 4: Permanent discontinuation

Hepatotoxicity :

Grade 2 increase in bilirubin: suspend until recovery and continue at the original dose

Grade 3 elevation in ALT/AST or bilirubin: suspend until recovery and then reduce dose

Grade 4: Permanent discontinuation

Medication Precautions

Diet :Must be taken with meals

Monitoring requirements :

Check blood routine before treatment and every 6 months

Regularly monitor weight gain (children)

Be alert to suicidal tendencies

Contraindications for :

Avoid alcohol

The suspension contains phenylalanine, use with caution in patients with phenylketonuria

Medicine for special groups

Pregnancy/breastfeeding :

Pregnancy: May be teratogenic, contraception is required during treatment and after stopping the drug

Breastfeeding: Not recommended

Children u200 c: Safe and effective for patients ≥2 years old

Liver insufficiency : Moderate to severe, dosage reduction is required

Renal insufficiency : Moderate to severe is not recommended

Adverse reactions

Common (≥10%) :

Drowsiness (67%), decreased appetite (45%), ataxia (27%), weight loss (27%), hypotonia Strength (24%), nausea (15%), tremor (15%)

Severe :

Neutropenia (13%), thrombocytopenia (13%), suicidal tendency

Contraindications

No absolute contraindications

Drug interactions

Clobazam : To increase its plasma concentration, the dose needs to be reduced

CYP3A4/CYP2C19 bottom Substance : May need to be reduced

Strong CYP1A2/CYP3A4/CYP2C19 inducer : Avoid combined use

Storage method

Save at 20-25°C, in original packaging and protected from light

Take immediately after preparation of the suspension