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Stiripentol - Indications, Dosage, Side Effects and Precautions

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Information about Stiripentol

Generic Name : Stiripentol
Up-to-date prescription details regarding Stiripentol are provided here.

Understand it's uses, recommended dosages, its indications, how to take, when to take, when not to take, side effects, special precautions, warnings and its and its storage instructions.
You will also find a list of the medication's International and Indian brand or trade names, as well as its pricing information. For verification of the information presented on this page or for additional clarifications, it's advisable to consult your doctor.


Therapeutic Classification : Anticonvulsants

Trade Names/Brand Names of Stiripentol

India :


Diacomit

Why is Stiripentol Prescribed? (Indications)

Stiripentol is used to treat Dravet syndrome (Previously Severe Myoclonic Epilepsy of Infancy or SMEI), a rare but severe type of epilepsy in young children which is usually triggered by fever or hot temperatures.

Stiripentol should only be used as an add-on therapy with clobazam and valproate in patients two years and above when clobazam and valproate have failed to control seizures.

Stiripentol has been given orphan drug status and works by reducing the frequency of seizures and also has an advantage of improving the effectiveness of other epileptic drugs used in the treatment schedule.

When should Stiripentol not be taken? (Contraindications)

Stiripentol should not be used in patients with-

• If there is an allergy to stiripentol
• History of psychotic illness particularly delirium, a state of mental confusion and behavioral changes
• Children below two years of age
• Severe liver or kidney disease

Caution is required when stiripentol is given to pregnant or breastfeeding women. A specialist opinion is necessary if women get pregnant during stiripentol therapy.

However, stiripentol should not be stopped as it may lead to worsening of seizures which can cause harm to both mother and the fetus.

Stiripentol should not be used alone or as a monotherapy in treating seizures that include major fits with the loss of consciousness.

What is the dosage of Stiripentol?

• The dose of stiripentol is calculated based on a patient’s body weight.

• The recommended daily dose of stiripentol is 50 mg/kg body weight given in 2 to 3 divided doses either as 25 mg/kg two times daily or 16.67 mg/kg three times daily.

• The dose of stiripentol should be gradually increased to reach the recommended dose of 50 mg/kg/day when administered along with clobazam and valproate.

• Stiripentol therapy can be started with a dose of 20 mg/kg/day in the first week and 30 mg/kg/day for the second week followed by a dose increase to a maximum of 50 mg/kg/day in the consecutive weeks.

• Stiripentol should be given to young children only after the diagnosis of Dravet syndrome is confirmed.

• The maximum recommended daily dose of stiripentol is 3000 mg.

• Stiripentol, when given along with clobazam, can lead to serious clobazam-induced side effects. In such cases, a dose reduction of clobazam can be considered to reduce the severity of the side effects.

How should Stiripentol be taken?

• Stiripentol is available both as capsules as well as in a powder form for oral suspension in strengths of 250 mg and 500 mg which should be taken by mouth with food.

• Children and patients with swallowing difficulties can take it as a liquid by mixing the powder for oral suspension in a glass of water (approximately 100 ml) and drinking it immediately.

• Add a little quantity of water (i.e., 25 ml) to the glass or the cup used for mixing stiripentol powder and drink to ensure that there is no leftover medication in the container.

• Adolescent patients can take capsules with food by swallowing as a whole with a sufficient quantity of water.

• Do not chew, break, crush, cut or open the contents of the stiripentol capsule.

Missed a Dose?

• Take the missed dose of stiripentol as soon as you remember.

• If the time of the next dose is very close, do not take the missed dose but take the following dose as per the next scheduled time.

• Never take a double dose of stiripentol to make up for the missed dose which is usually harmful.

What are the warnings and precautions for Stiripentol?

• Stiripentol can induce a strong desire to sleep. So, patients must be advised not to drive, operate heavy machinery or engage in hazardous activities as stiripentol can affect mental alertness.

• Children treated with stiripentol should be monitored for their growth status as stiripentol can decrease appetite and weight.

• A blood test must be performed before starting stiripentol treatment followed by every six months as stiripentol can cause a decrease in the level of neutrophils, a type of white blood cell, and a decrease in platelets resulting in neutropenia and thrombocytopenia respectively.

• Liver functions should also be checked before initiating stiripentol treatment and should be repeated every six months.

• Patients can experience suicidal thoughts or unusual mood changes during the treatment with stiripentol. So, patients should be carefully monitored and caregivers must be advised to consult the doctor immediately if any such behavioral changes are seen.

• Avoid alcohol consumption and limit the use of other drugs that act on the brain (CNS) while taking stiripentol as the effects of sleepiness or drowsiness are significantly increased by alcohol or the CNS drugs.

What are the side effects of Stiripentol?

Gastrointestinal: Nausea, vomiting, excess secretion of saliva, loss of appetite
Nervous system: Drowsiness, unintentional muscle movements, and reduced muscle strength, anxiety, changes in the manner of speech or walking, inability to sleep, feelings of anger or aggression
Respiratory: Cough, chest tightness, shortness of breath, wheezing, lung infection such as bronchitis or nasopharyngitis
Skin: Rashes, itching, sensitivity to sunlight, allergic reactions
Others: Fever, unusual weakness or tiredness, lab abnormalities of liver function

What are the other precautions for Stiripentol?

• Patients taking stiripentol should be advised not to stop taking stiripentol suddenly without the doctor’s advice as it may cause withdrawal symptoms or can increase the risk of seizures or status epilepticus which is harmful.

• Contact the nearest emergency center or poison control center in case of stiripentol overdose and the patient should be treated under the supervision of a specialist particularly in an ICU setting.

What are the Drug Interactions of Stiripentol?

Dose adjustment of the following medications should be considered when stiripentol is given along with-

Theophylline
• Sertraline
• Midazolam
• Quinidine
• Caffeine

The dose of the following drugs can be decreased to minimize the side effects induced by these drugs when used along with stiripentol.

• Clobazam
• Clopidogrel
• Methotrexate
Diazepam
• Prazosin
• Glyburide

The following drugs can decrease the concentration of stiripentol and therefore should be avoided, or dose modifications can be done as advised by the doctor.

• Rifampicin
Phenytoin
• Phenobarbitone

What are the storage conditions for Stiripentol?

• Store stiripentol capsules and powder for oral suspension at a room temperature below 25°C.

• Keep stiripentol in its original package to protect from excess light and moisture.

• Keep the medicines out of reach of children.
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