Stiripentol

Generic name: Stiripentol
Brand names: Diacomit
Drug class: Gamma-aminobutyric acid reuptake inhibitors

Usage of Stiripentol

Stiripentol is used to treat seizures associated with Dravet syndrome. Dravet syndrome is a rare chronic form of epilepsy that begins in the first year of life and causes frequent or prolonged seizures.

Stiripentol is for use in adults and children at least 6 months old and weighing 15 lbs (7 kg) or more who also take another medicine called clobazam.

Stiripentol may also be used for purposes not listed in this medication guide.

Stiripentol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Stiripentol may cause serious side effects. Call your doctor at once if you have:

severe drowsiness;

significant weight loss;

easy bruising, unusual bleeding, purple or red spots under your skin; or

low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects of stiripentol may include:

nausea, loss of appetite;

weight loss;

drowsiness;

agitation;

problems with balance or muscle movement;

tremor, slurred speech;

muscle weakness; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Stiripentol

Tell your doctor if you have ever had:

liver or kidney disease;

suicidal thoughts or actions;

depression, a mood disorder; or

if you drink alcohol.

The powder form of this medicine may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

A small number of people have thoughts about suicide while taking stiripentol. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of stiripentol on the baby.

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How to use Stiripentol

Usual Adult Dose for Dravet Syndrome:

25 mg/kg orally twice a day or 16.67 mg/kg orally 3 times a dayMaximum dose: 3000 mg/dayComments:-No clinical data are available to support the use of this drug as monotherapy in Dravet syndrome.-The total daily dose is 50 mg/kg/day.Use: For the treatment of seizures associated with Dravet syndrome in patients taking clobazam

Usual Pediatric Dose for Dravet Syndrome:

6 months to less than 1 year:-Weight at least 7 kg: 25 mg/kg orally twice a day1 year and older:-Weight 7 to less than 10 kg: 25 mg/kg orally twice a day-Weight at least 10 kg: 25 mg/kg orally twice a day or 16.67 mg/kg orally 3 times a dayMaximum dose: 3000 mg/dayComments:-No clinical data are available to support the use of this drug as monotherapy in Dravet syndrome.-The total daily dose is 50 mg/kg/day.-For patients 6 months to less than 1 year: Dosing frequency should not exceed twice a day to limit free water administration and to avoid overexposures.-For patients 1 year and older weighing 7 to less than 10 kg: Dosing frequency should not exceed twice a day to avoid overexposures.Use: For the treatment of seizures associated with Dravet syndrome in patients taking clobazam

Warnings

Stiripentol can cause drowsiness, especially if you also drink alcohol or take other medicines that can make you sleepy. Tell your doctor about all your current medicines and any you start or stop using. Avoid driving or hazardous activity until you know how stiripentol will affect you.

A small number of people have thoughts about suicide while taking stiripentol. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What other drugs will affect Stiripentol

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using stiripentol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect stiripentol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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