Diacomite

Diacomite

What is Diacomite?

Diacomit is intended for use in adults and children aged at least 6 months and weighing 7 kg or more who are also taking another medicine called clobazam.

There are no clinical data to support the use of Diacomit alone for the treatment of Dravet syndrome.

Warnings

Diacomit can cause drowsiness, especially if you also drink alcohol or take other medicines that can make you sleepy. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping. Avoid driving and dangerous activities until you know how this medicine affects you.

A small number of people have suicidal thoughts while taking Diacomit. Watch for mood changes or symptoms. Report any new or worsening symptoms to your doctor.

Before you take this medicine

Diacomit should not be given to children under 6 months of age.

To make sure Diacomit is safe for you, 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 suicidal thoughts while taking Diacomit. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also monitor for mood changes or symptoms.

Do not start or stop taking seizure medications during pregnancy without your doctor's advice.Stiripentol can harm an unborn baby, but a seizure during pregnancy could harm both the mother and the baby. The benefits of preventing seizures may outweigh the risks.Tell your doctor immediately if you become pregnant.

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

Breastfeeding may not be safe while using this medication. Ask your doctor about any risks.

How should I take Diacomit?

Use Diacomit exactly as your doctor has told you. Your doctor will do blood tests to make sure you do not have any medical conditions that would prevent you from using Diacomit safely.

Follow all instructions on your prescription label and read any medication guides or instructions for use.

Always take this medicine with a meal.

Swallow thatcapsuleStore whole and do not crush, chew, break or open.

You may need to take Diacomit capsules in two different strengths to get the right dose. Follow your doctor's dosage instructions very carefully.

Take thatcapsulewith a full glass of water.

Dissolve one packet of powder in 3 ounces of water. Stir and drink this mixture immediately. Add at least 30ml more water to the glass, swirl gently and drink immediately.

The dosage of Stiripentol depends on weight. Your dosage needs may change if you gain or lose weight.

Diacomit can cause nausea, vomiting, loss of appetite and weight loss. Weigh yourself often and tell your doctor if you start to lose weight. Your medication dosage may need to be adjusted.

Do not change the dosage or dosage of Diacomit or other seizure medications without your doctor's advice.

Decreased appetite and weight loss can affect a child's growth. Your doctor will need to check your child's growth rate periodically.

Stiripentol may increase your risk of bleeding or infection. You need frequent medical examinations.

Store at room temperature, protected from moisture, heat and light.

Do not stop using Diacomit suddenly, even if you feel well. If you suddenly stop using Diacomit, seizures may increase. Follow your doctor's instructions for reducing the dose.

Dosage information

Usual Adult Dose for Dravet Syndrome:

25 mg/kg orally twice daily or 16.67 mg/kg orally three times daily
Maximum dose: 3000 mg/day

Comments:
-There are no clinical data to support the use of this drug as monotherapy in Dravet syndrome.
-The total daily dose is 50 mg/kg/day.

Uses: 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 daily

1 year and older:
-Weight 7 to less than 10 kg: 25 mg/kg orally twice daily
-Weight at least 10 kg: 25 mg/kg orally twice daily or 16.67 mg/kg orally three times daily
Maximum dose: 3000 mg/day

Comments:
-There are no clinical data 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 of age: Dosing frequency should not be exceeded twice daily to limit free water administration and avoid overexposure.
-For patients 1 year of age and older weighing 7 to less than 10 kg: Dosing frequency should not be exceeded twice daily to avoid overexposure.

Uses: For the treatment of seizures associated with Dravet syndrome in patients taking clobazam

What happens if I miss a dose?

Take the medicine as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not take two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What to avoid

Avoid driving and dangerous activities until you know how this medicine affects you. Your reactions may be affected.

Don't drink alcohol.Drinking alcohol with this medicine may cause severe drowsiness.

Diacomit side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Diacomit:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: B. Changes in mood or behavior, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts of suicide or self-harm.

Call your doctor immediately if you have:

• severe drowsiness;

• significant weight loss;

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

• low white blood cell count– Fever, mouth sores, sore skin, sore throat, cough, difficulty breathing.

Common side effects of Diacomit may include:

• nausea, loss of appetite;

• weight loss;

• Sleepiness;

• 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Diacomit?

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

Using Diacomit with other medicines that make you sleepy may worsen this effect. Consult your doctor before taking opioid medications, sleeping pills, muscle relaxants, or anti-anxiety or seizure medications.

Other medications may interact with stiripentol, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others and only use Diacomit for the prescribed indication.