STIRIPENTOL

What is Stiripentol?

Stiripentol is in a class of medications called Anti-Seizure Medication used to prevent or reduce the frequency of seizures. It is not licensed in India.

What is Stiripentol used for?

Dravet syndrome–associated seizures in patients 2 years of age and older. It is used in combination with clobazam or valproate.

How is Stiripentol available? (Indian Context – Expensive and has to be imported via agencies)

Capsules.

Powder for oral suspension (250 mg and 500 mg)

Blood levels can vary with capsule and powder, hence dose needs monitoring when switching between capsule and powder.

How does Stiripentol act (mechanism of action)?

Stiripentol produces anticonvulsant effects by various modes of action.

Possible mechanisms include direct actions on the gamma-aminobutyric acid (GABA)A receptor and indirect actions through inhibition of cytochrome P450 enzymes, which can raise blood levels of Clobazam and its active metabolite.

How much time does Stiripentol take to act?

Generally, Stiripentol starts to show clinical effects within 1 to 2 weeks of starting the treatment, but it may take few weeks (around 4 to 6 weeks) for the full therapeutic effects to become noticeable. In some cases, the medication may need to be adjusted to achieve the best balance between effectiveness and side effects.

What is the ideal time to take Stiripentol?

Take it twice a day, about 10–12 hours apart — for example, around 7–8 am and then again around 7–8 pm.

In certain cases, though, your doctor could recommend giving it three times a day. In this situation, kindly heed your doctor’s directions.

To create a routine and reduce the likelihood of skipping a dose, it should ideally be administered at the same time each day.

When should Stiripentol be Given?

You should give the medication after a meal or snack, which improves absorption. Avoid giving it on an empty stomach, as this can reduce how much of the medicine is absorbed and may make it less effective. Avoid consuming milk or dairy products or fruit juice.

How should I give the medicine?

Capsules: It can be swallowed whole with water.

For younger children who cannot swallow capsules: Open the capsule and mix the powder with a small amount of soft food that does not contain fat or protein. Administer the mixture immediately and ensure the child consumes all of it.

Powder for oral suspension: The powder for suspension should be mixed in a glass of water and taken right after preparation during a meal. After finishing, add another ~25 mL of water to the glass and drink that too, to make sure you take the full dose

Would my child experience any negative effects from this medication?

Medicines can help you a lot, but they can also cause side effects — most people don’t have any, and when they do, they’re usually mild. Still, some side effects can be serious — if you notice anything unusual or worrying, talk to your doctor or seek medical help right away.

Side effects (Adverse effects) of Stiripentol:

Somnolence (drowsy)

Decreased Appetite and Weight loss

Neutropenia and Thrombocytopenia

Phenylketonuria

Suicidal Behavior and Ideation

Does Stiripentol cause weight gain?

Stiripentol is associated with weight loss as a minor side effect.

Can other common medicines be taken during the course of Stiripentol?

When taking Stiripentol, you need to be careful: it can boost levels of drugs like clobazam and valproate, so their doses may need to be lowered. It also affects liver enzymes, which can change how medicines like warfarin or hormonal contraceptives work. If used with sedatives, it can make you more drowsy. Some antibiotics (like rifampicin) can reduce its effect, while others (like ketoconazole) can make its levels go up. Always check with your doctor before starting or mixing other medications.

What food to avoid while taking Stiripentol?

When taking Stiripentol, there are no specific foods that must be strictly avoided, However, there are a few general recommendations to consider:

PREGNANCY AND BREASTFEEDING:

There’s very limited human data on Stiripentol in pregnancy and Breastfeeding, so it’s used only if the potential benefit outweighs possible risks. Final decision must be taken after consulting the concerned physician.

Is there any risk if I conceive while taking Stiripentol?

Yes — there might be a risk if you conceive while on Stiripentol: animal studies showed increased fetal harm. There’s very limited human pregnancy data, so if you get pregnant when you are on Stiripentol, your doctor will carefully weigh the benefits vs. the risks and help plan how to manage your treatment safely.

Can I stop taking Stiripentol? (withdrawal)

Drug should not be discontinued abruptly because the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency.

MONITORING PARAMETERS OF STIRIPENTOL:

Complete blood count (prior to initiation and every 6 months or as clinically indicated)
Liver function test and renal function test
Weight
Growth rate in children
Signs and symptoms of psychiatric events

How to cope with side effects of Stiripentol?

Irritability or Mood Changes

Encourage calming activities like reading, drawing, or quiet play.

Use relaxation techniques, such as deep breathing or soothing music, if age-appropriate.

Keep a diary to track behavioural changes and discuss them with the doctor.

Severe mood changes or aggression should be reported immediately.

Dizziness or Drowsiness

Ensure the child avoids activities requiring balance or coordination (e.g., climbing, running on uneven surfaces).

Provide supervision to prevent falls or injuries.

Nausea or Vomiting

Offer smaller, more frequent meals and avoid greasy or spicy foods.

Feeding or Appetite Issues

Monitor the child’s weight and growth regularly.

Offer nutrient-dense snacks to maintain proper nutrition.

If appetite suppression persists, discuss with the doctor for possible dietary supplements or adjustments.

Rash or Allergic Reactions (Rare but Serious)

Stop the medication immediately and seek medical attention if a rash, swelling, or difficulty breathing occurs.

General Tips for Parents

Record any symptoms or changes in behaviour, appetite, or mood to share with the healthcare provider.

Regularly update your doctor about side effects, even if they seem minor. This helps with timely dose adjustments.

Missing doses can lead to seizure recurrence, and doubling doses increases the risk of side effects.

For older children, explain what to expect and encourage them to communicate how they’re feeling.

When to Contact the Doctor:

If side effects worsen or become severe (e.g., excessive sedation, persistent vomiting, or behavioural changes).

For signs of an allergic reaction (rash, swelling, difficulty breathing).

If seizures increase or new symptoms appear.

SUMMARY:

Stiripentol is an anticonvulsant used to treat Dravet syndrome, often combined with other medications like valproic acid and clobazam. It helps reduce seizure frequency. Common side effects include drowsiness, loss of appetite, and nausea, while serious effects can include low white blood cell and platelet count. It can interact with other drugs, so consult a doctor before combining it. Avoid grapefruit, alcohol, and high-fat meals while taking it. Regular check-ups are important for monitoring its effectiveness and safety.

Let us know if this information was useful!

REFERENCE:

1. https://www.ijpp.in/admin/uploadimage/Apr-June-2016.pdf
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf
3. https://www.diacomit.com/downloads/pdf/BBD-00002-092019%20DIACOMIT%20US%20PI.pdf

Author:

Dr. Likitha B S, Pharm. D, Clinical Pharmacologist, Aster Hospitals, Bengaluru
Dr Praveen Kumar, B. Pharm, Pharm D(PB), Lead Clinical Pharmacologist, REGIONAL HEAD KIMS Hospitals, Bengaluru
Dr. C. P. Ravi Kumar Lead & Senior Consultant – Paediatric Neurology KIMS HOSPITALS BENGALURU

Share the Post: