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Diacomit

Generic name: stiripentol [STIR-i-PEN-tol]
Class of drugs: Reuptake Inhibitors for Gamma Aminobutyric Acid

What is Diacomit ?

Diacomit is a prescription medication used for seizures caused by Dravet syndrome. Dravet syndrome is a chronic form of epilepsy that begins during the first year and results in frequent or long seizures. Diacomit can be used by adults or children who are at least six months old, weigh 15 pounds (7 kilograms) or more, and also take Clobazam. Diacomit is not a treatment for Dravet syndrome.

Warnings

Diacomit may cause sleepiness, particularly if you are also taking alcohol or other medications that make you sleepy. Inform your doctor of all the medicines you are taking and those that you have started or stopped using. Do not drive or engage in hazardous activities until you have determined how the medicine affects you. Diacomit can cause suicidal thoughts in a small percentage of users. Be alert for any changes in mood or symptoms. Notify your doctor of any symptoms that are new or getting worse.

Before you take this drug

Diacomit is not recommended for children younger than six months.

Tell your doctor about any of the following to ensure Diacomit will be safe for you:

  • Liver or kidney disease
  • Suicidal ideas or acts
  • Depression is a mental disorder.
  • If you are a heavy drinker of alcohol,

This medicine is available in powdered form. It may contain phenylalanine. Inform your doctor of any phenylketonuria. Diacomit can cause suicidal thoughts in a small percentage of patients. At regular appointments, your doctor should check on you.Your family should also be made aware of any fluctuations or symptoms which arise within you or may occur as part of their overall well-being. You should not stop or start taking seizure medications without consulting your doctor. A seizure can harm the unborn child, but a mother having one during pregnancy may also harm her baby. Preventing seizures could be worth the risk.Notify your doctor immediately if you think you may be pregnant. You may find your name on a registry for pregnant women to monitor the effects stiripentol has on the child. Breastfeeding may be unsafe while taking this medication. You should ask your doctor if there are any risks.

Similar/related drugs

Epidiolex, Fintepla, Cannabidiol, Fenfluramine, and Stiripentol

How to take Diacomit?

Diacomit should be taken exactly as directed by your doctor. Diacomit is only prescribed if you are healthy. Your doctor will conduct blood tests to ensure that you don't have any conditions that would make Diacomit unsafe for you. Read all the instructions and directions included on the prescription label. Take this medication with a full meal. Do not open, crush or chew the capsule. Diacomit may be taken in two strengths to get the correct dosage. Dosage instructions should be followed very closely. Take one capsule along with an entire glass full of water. One packet should be dissolved in three ounces of water. Mix the powder and water together, then drink it immediately. Pour at least one ounce of water into the glass. Swirl gently, and then drink immediately. Stiripentol dosage is based on your weight. Your dose needs may change if you gain or lose weight. Diacomit may cause nausea and vomiting. It can also lead to a loss of appetite or weight gain. Tell your doctor when you start to lose weight. You may have to adjust your medication dosages.

Diacomit and other medications that treat seizures should not be changed without consulting your doctor. A child's growth can be affected by a decreased appetite or weight loss. You will have to visit your doctor regularly in order to monitor the growth of your child. Stiripentol increases your chances of infection or bleeding. Medical tests will be required frequently. Keep away from heat, moisture, and light. Even if you are feeling fine, do not suddenly stop taking Diacomit. If you suddenly stop taking Diacomit, seizures may worsen. You should follow your doctor's advice about reducing your dosage.

Details on dosage

Usual Adult Dose for Dravet Syndrome:
Orally, 25 mg/kg twice daily or 16,67 mg/kg three times per day
Maximum dose: 3000 mg/day
Comments:
No clinical evidence is available that supports the monotherapy of Dravet syndrome with this drug.
The total dose per day is 50 mg/kg/day.
Treatment of Dravet Syndrome in patients who are taking Clobazam
The usual pediatric dose for Dravet Syndrome
Six months is less than one year.
Weight at least 7kg: Orally, 25 mg/kg twice daily
One year old and older
Weight: 7 kg to 10 kg or less Orally, 25 mg/kg twice daily
Weight at least 10kg: Orally, take 25 mg/kg twice daily or 16,67 mg/kg three times per day.
Maximum dose: 3000 mg/day
Comments:
No clinical evidence is available that supports the monotherapy of Dravet syndrome with this drug.
The total dose per day is 50 mg/kg/day.
For patients aged 6 months and less than a year, the frequency of administration should not be more frequent than twice daily to prevent overexposure.
For patients older than 1 year, weighing between 7 and 10 kilograms, the dose should be administered no more often than twice daily to prevent overexposure.
Treatment of Dravet Syndrome in patients who are taking Clobazam

What happens if I miss the dose?

If you are almost due for the next dose, skip the missed one. Never take more than one dose at a time.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Do not drive or engage in hazardous activities until you have determined how the medicine affects you. You may be unable to react properly. Avoid drinking alcohol. Alcohol can make you drowsy.

Side effects of Diacomit

If you experience any of the following symptoms of an allergy to Diacomit, seek immediate medical attention: itching, difficulty breathing, swelling in your lips, face, throat, tongue, or mouth. You should tell your doctor if any symptoms worsen or change, including changes in mood, behavior, anxiety, or panic attacks; or if you are feeling irritable or angry, restless or hyperactive, depressed, or thinking about harming yourself or committing suicide.

If you experience:

  • Severe drowsiness;
  • Significant weight loss
  • If you notice bruising or bleeding under the skin, or if it is unusual, or if there are purple or pink spots or a rash, or if your skin appears to be tinged with red or purple, or if you have a rash or bleed easily, or unless
  • Low white blood cells (fever, mouth sores, and skin sores) throat: cough, trouble breathing.

Some of the common diarrhea symptoms include:

  • Nausea, nausea, and loss of appetite
  • Weight loss;
  • Drowsiness;
  • Agitation;
  • Problems with muscle or balance movement
  • Tremors, speech slurred;
  • Muscle weakness
  • Sleep problems (insomnia).

There may be other side effects. For medical advice on side effects, call your doctor. Report side effects by calling the FDA at 1-800-FDA-1088.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking. Diacomit can make this worse if you take it with drugs that cause drowsiness. Before taking an opioid, sleeping pills, muscle relaxers, anxiety medications, or medicines for seizures or anxiety, consult your doctor. Stiripentol may also interact with other drugs, such as vitamins and herbs. Inform your doctor of all the medicines you are taking and those that you stop or start using.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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