Stiripentol Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Stiripentol Capsule (generic name: stiripentol) is an antiepileptic medicine used together with clobazam and valproate to help control seizures in people with Dravet syndrome (severe myoclonic epilepsy in infancy) whose seizures are not well controlled by clobazam and valproate alone. It works by boosting a calming brain chemical and by raising blood levels of the other seizure medicines taken with it. It is taken with food, following a dosing schedule set by a specialist doctor, and it comes with specific precautions around blood counts, liver function, and other medicines.

What is Stiripentol Capsule

Stiripentol Capsule is a seizure medicine (anticonvulsant). It is used together with two other seizure medicines, clobazam and valproate, to help control seizures in people with Dravet syndrome, also called severe myoclonic epilepsy in infancy, whose seizures are not well controlled by clobazam and valproate alone.

Stiripentol Capsule uses

• Add-on (adjunctive) therapy for refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (Dravet syndrome) whose seizures are not adequately controlled with clobazam and valproate, used together with clobazam and valproate.

Benefits of Stiripentol Capsule

• Helps control seizures
• Reduces convulsive seizures
• Helps manage Dravet syndrome
• Improves seizure control with other medicines
• Supports epilepsy treatment

How Stiripentol Capsule works

Stiripentol seems to boost the activity of GABA, a natural brain chemical that calms down nerve signals, which helps reduce seizures. It also blocks certain liver enzymes, which raises the blood levels of the other seizure medicines (like clobazam) taken alongside it, making them work more strongly.

Stiripentol Capsule dosage

Always take this medicine with food, because it breaks down quickly in an empty, acidic stomach. Do not take it with milk or dairy products such as yoghurt or soft cream cheese, carbonated drinks, fruit juice, or foods and drinks containing caffeine or theophylline (such as cola, chocolate, coffee, tea, and energy drinks).

Swallow capsules whole with a glass of water; do not open, break, or chew them, so the full amount of medicine is taken. If using the oral powder, mix it in a glass of water and drink it right away during a meal.

The daily amount is usually split into two or three doses spread through the day, for example morning, midday, and bedtime, to cover day and night. In young children, the starting dose is increased gradually over several weeks, with the pace of increase depending on the child's age. Treatment should only be started and supervised by a children's doctor or children's nerve specialist experienced with epilepsy.

Do not stop taking this medicine suddenly, as this can cause seizures to return or worsen; any changes should be guided by the doctor.

If vomiting happens within the first few minutes after taking a dose, it is assumed the medicine was not absorbed and a new dose should be given; if vomiting happens more than an hour after taking the dose, no extra dose or adjustment is usually needed because the medicine is absorbed quickly.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not take a double dose to make up for a missed one.

Switching between the capsule and the oral powder forms should be done under close medical supervision, as the two forms are not exactly equivalent.

Available forms and strengths

• Hard capsules (100 mg, 250 mg, 500 mg)

Side effects of Stiripentol Capsule

Common

• Loss of appetite and weight loss
• Insomnia (trouble sleeping)
• Drowsiness
• Ataxia (problems with coordination and balance)
• Low muscle tone (hypotonia)
• Dystonia (involuntary muscle contractions)
• Raised liver enzyme levels
• Aggressiveness, irritability, agitation, or behaviour changes
• Sleep disturbances
• Hyperkinesia (exaggerated movements)
• Nausea and vomiting
• Low white blood cell count

Serious

• Severe allergic reactions (skin rash, itching, hives, swelling of face, lips, tongue, or throat)
• Low platelet count, which can cause easy bruising or bleeding problems
• Abnormal liver function
• Signs of infection such as fever, chills, sore throat, or pneumonia
• Suicidal thoughts or behaviour, or worsening mood or depression
• Double vision (when combined with carbamazepine)
• Sensitivity to light, rash, or skin allergy

Warnings and precautions

• This medicine must not be used by anyone who has had episodes of delirium (confusion with hallucinations) in the past, or who is allergic to stiripentol or any of its ingredients.
• Certain older seizure medicines (carbamazepine, phenytoin, and phenobarbital) should not be used together with this medicine for Dravet syndrome.
• This medicine can lower white blood cell counts, which may be linked with other epilepsy medicines taken alongside it. Blood counts should be checked before starting and then every 6 months.
• This medicine strongly affects certain liver enzymes and can raise blood levels of many other medicines, increasing the chance of side effects; care is needed when combining it with other drugs.
• Combining this medicine with certain other drugs (such as ergotamine, cisapride, pimozide, quinidine, bepridil, or some immunosuppressants and statins) should be avoided unless strictly necessary because of serious risks like heart rhythm problems or muscle damage.
• Children taking this medicine, especially combined with valproate, may have reduced appetite, weight loss, nausea or vomiting, so growth should be carefully monitored.
• As with other seizure medicines, this medicine should be stopped gradually under medical guidance, as sudden stopping can cause seizures to return or worsen.
• A small number of people taking seizure medicines like this one have had thoughts of suicide or self-harm; any unusual changes in mood or behaviour should be reported to a doctor right away.
• The oral powder form contains a source of phenylalanine (aspartame), which may be harmful to people with phenylketonuria (PKU).
• Stiripentol has not been well studied in pregnant women. Effective epilepsy treatment should not be stopped during pregnancy because uncontrolled seizures can harm both mother and baby, but use of stiripentol during pregnancy needs an individual decision by the doctor weighing benefits and risks, and reliable contraception is recommended.
• Breastfeeding is not recommended while taking this medicine, because it is not known whether it passes into human breast milk, although it does pass into milk in goats. If breastfeeding continues during treatment, the baby should be watched closely for side effects.
• This medicine is not recommended for people with kidney problems, because it has not been specifically studied in this group.
• This medicine is not recommended for people with liver problems. Liver function should be checked before starting treatment and then every 6 months.
• Alcohol can make the sleepiness and dizziness caused by this medicine worse, so you should ask your doctor about safe alcohol use while taking it.
• This medicine can cause dizziness and problems with coordination, so patients should not drive or use machinery until they know how the medicine affects them.

Storage

• This medicinal product does not require any special storage conditions (100 mg capsules).
• Store in the original package in order to protect from light (250 mg and 500 mg capsules, and all oral powder sachets).
• Keep out of the sight and reach of children.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
• Do not throw away medicines via wastewater or household waste; ask your pharmacist how to dispose of medicines you no longer use.

When to see a doctor

• Get medical help right away if you or your child has signs of an allergic reaction, such as rash, itching, hives, or swelling of the face, lips, tongue, or throat.
• Contact the doctor immediately if there are signs of infection like fever, chills, sore throat, or cough, which could mean a drop in white blood cells.
• Seek medical advice promptly for unusual bruising, bleeding, or blood in urine or stool, which could be signs of a low platelet count.
• Call the doctor right away if there are thoughts of suicide or self-harm, worsening mood, new depression, or other unusual changes in behavior.
• Contact the doctor if your child is losing weight or appetite is a concern, so growth can be monitored.
• If you think too much medicine has been taken (overdose), contact a poison control center or go to an emergency room right away, as overdose can cause breathing problems.

Alternatives

• Cannabidiol
• Levetiracetam
• Clobazam