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Diacomit

(stiripentol)

How does this medication work? What will it do for me?

Stiripenol belongs to the class of medications known as antiepileptics. It is used in combination with other medications the treat generalized tonic-clonic seizures for patients with severe myoclonic epilepsy in infancy, (Dravet syndrome) when the seizures are not controlled by other medications. It has not been determined yet exactly how it works to reduce seizures.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The dose of stiripenol is based on body weight. The recommended dose is 50 mg per kilogram of body weight each day, divided into 2 or 3 equal doses. Stiripentol should be started at a low dose and increased over 3 days to a daily dose of 50 mg per kilogram of body weight.

The capsule should be swallowed whole with a glass of water. Do not break or open the capsule.

The powder form of this medication should be mixed in a glass of water and taken immediately after mixing.

This medication should be taken with food as it breaks down in the acid that exists in an empty stomach. Avoid taking stiripenol with milk or dairy products, carbonated drinks, fruit juice or food and drinks that contain caffeine or theophylline. Do not take stiripentol with alcoholic beverages.

If it is necessary to stop taking this medication, the daily dose should be gradually reduced over the period of a month, to reduce the risk of seizures or increased frequency of seizures.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

250 mg
Each size 2 pink gelatin capsule contains 250 mg stiripentol. Nonmedicinal ingredients: erythrosine, gelatin, indigotine, magnesium stearate, povidone, sodium starch glycolate, titanium dioxide.

500 mg
Each size 0 white gelatin capsule contains 500 mg stiripentol. Nonmedicinal ingredients:gelatin, magnesium stearate, povidone, sodium starch, glycolate, titanium dioxide.

Powder for suspension

250 mg
Each packet of tutti frutti flavoured powder for suspension contains 250 mg stiripentol. Nonmedicianl ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavour.

500 mg
Each packet of tutti frutti flavoured powder for suspension contains 500 mg stiripentol. Nonmedicianl ingredients: aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavour.

Who should NOT take this medication?

Do not take this medication if you are allergic to stiripentol or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • confusion
  • decreased muscle coordination and tone
  • difficulty concentrating
  • difficulty sleeping
  • dizziness
  • dry, itchy skin
  • increased production of saliva
  • loss of appetite
  • nausea
  • nightmares
  • speech difficulties
  • tiredness
  • vomiting
  • unusual, increased muscle contractions

weight loss Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • behaviour changes (e.g., agitation, nervousness, aggression)
  • movement disorders
  • signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • thoughts of hurting oneself or others

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Caffeine: This medication interacts with caffeine and other similar substances. People who take stiripenol should avoid colas, chocolate, coffee, tea and energy drinks.

Delirium and hallucinations: Rarely, this medication has been linked to delirium or hallucinations when taken by adults. If you have a history of psychoses or delirium, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/Reduced Alertness: Stiripentol may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Growth Problems: Stiripentol can cause appetite loss and stomach upset which may result in loss of weight. For children this can result in growth problems. Your child's growth rate should be monitored by your doctor while taking this medication. Talk to your doctor if your child is experiencing significant loss of appetite and weight loss.

Infection: This medication can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Reduced kidney function may cause this medication to build up in the body and cause side effects. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly with blood tests while you are taking this medication.

Liver function: The effect of reduced liver function on how the body uses stiripentol has not been studied. Stiripentol may reduce liver function and can cause liver problems. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately

Other medications for seizures: It is important to avoid taking carbamazepine, phenytoin or phenobarbital when using this medication. If you or your child are using any of these medications, discuss with your doctor the appropriate way to change medications.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Pregnancy: Although there is no information on the effect that this medication can have on the developing baby if it is taken by the mother during pregnancy, many medications that are used to treat seizures cause harm to the unborn baby. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking stiripentol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Seniors: There is no information regarding the safe and effective use of this medication by older adults. Seniors may be more likely to experience side effects because of liver and kidney impairment.

What other drugs could interact with this medication?

There may be an interaction between stiripentol and any of the following:

  • alcohol
  • alprazolam
  • "azole" antifungals (e.g., itraconazole, ketoconazole, posaconazole)
  • beta-blockers (e.g.,carvedilol, propranolol)
  • caffeine
  • calcium channel blockers (amlodipine, diltiazem, verapamil)
  • carbamazepine
  • chlorpheniramine
  • chlorpromazine
  • cisapride
  • clobazam
  • codeine
  • cyclosporine
  • dextromethorphan
  • diazepam
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • fentanyl
  • haloperidol
  • HIV protease inhibitors (e.g., darunavir, lopinavir, ritonavir)
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • midazolam
  • omeprazole
  • oral contraceptives
  • phenobarbital
  • phenytoin
  • pimozide
  • quinidine
  • selective serotonin reuptake inhibitors (SSRIs; fluoxetine, paroxtine, sertraline)
  • sirolimus
  • "statin" cholesterol medications (e.g., atorvastatin, simvastatin)
  • tacrolimus
  • theophylline
  • topiramate
  • tramadol
  • triazolam
  • tricyclic antidepressants (e.g., clomipramine, imipramine)
  • valproate

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Diacomit

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