Diacomit (Generic Stiripentol)
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Why is this medication prescribed?
When a patient has Dravet syndrome and weighs at least 7 kg (15 pounds), stiripentol and clobazam (Onfi®, Sympazan®) are used to treat seizures (a disorder that begins in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking). A class of drugs known as anticonvulsants includes stiripentol. It affects brain activity by reducing aberrant excitation.
How should this medicine be used?
Both a capsule and a powder form of stiripentol are available for oral consumption. It is typically consumed with meals two or three times per day. Take stiripentol every day at around the same time(s). Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Follow the stiripentol directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.
Do not open or split the capsules; instead, swallow them whole with a glass of water.
You must mix the powder with water right before consuming it if you’re using it for oral suspension. The quantity of stiripentol powder to use and the amount of water to mix it with will be specified by the doctor. Read the manufacturer’s instructions, which spell out how to combine and consume stiripentol, thoroughly. If you have any queries regarding how to combine or take this medication, make sure to consult your chemist or doctor.
While not curing your illness, stiripentol manages it. Even if you are feeling better, keep taking stiripentol. Even if you encounter adverse effects such unexpected behavioural or emotional changes, you should not discontinue taking stiripentol without first consulting your doctor. Your seizures can get worse if you abruptly stop using stiripentol. Your dose will likely be gradually reduced by your doctor.
The patient information sheet (Medication Guide) from the manufacturer will be provided to you by your doctor or chemist when you start taking stiripentol and at each time your prescription is renewed. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).
Other uses for this medicine
Ask your doctor or chemist for more details if you believe this drug should be used for something else.
What special precautions should I follow?
Before taking stiripentol,
- If you have any allergies, including to any of the substances in stiripentol capsules or the oral powder for suspension, contact your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
- Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Stiripentol may also interact with many other drugs, so be sure to inform your doctor of all the drugs you’re taking even ones not on this list.
- Moreover, let your doctor know if you now or ever had renal or liver disease, depression, mood disorders, suicidal thoughts or conduct.
- Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking stiripentol.
- You need to be aware that stiripentol may cause you to feel woozy or sleepy and may impair your coordination. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
- Consult your doctor about whether drinking alcohol is safe while taking stiripentol. The negative effects of stiripentol can be exacerbated by alcohol.
- You should be aware that stiripentol oral powder is sweetened with aspartame, which creates phenylalanine, if you have phenylketonuria (PKU), an inherited condition that necessitates the consumption of a special diet in order to prevent brain damage that could result in severe intellectual disability.
- You should be aware that while using stiripentol, your mental health may alter in unexpected ways and you could develop suicidal thoughts (plans or attempts to injure or kill yourself, or thoughts of doing so). One in 500 adults and children aged 5 and older who were treated with anticonvulsants like stiripentol in clinical studies for a variety of disorders developed suicidal thoughts while on the medication. Some of these individuals started exhibiting suicidal thoughts and actions as little as one week after beginning the medicine. Whether the hazards of using an anticonvulsant drug outweigh the dangers of not using it will be decided by you and your doctor. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: agitation or restlessness; panic episodes; acting on risky impulses, new or increasing irritation, anxiety, or despair, trouble falling or keeping asleep; harsh, irate, or confrontational conduct Mania (an irrationally frantic and ecstatic state); any other odd changes in behaviour or mood, including ideas, plans, or attempts to injure or kill oneself. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.
What special dietary instructions should I follow?
If you consume large amounts of caffeine-containing foods or beverages such coffee, tea, energy drinks, cola, or chocolate, talk to your doctor.
What should I do if I forget a dose?
If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.
What side effects can this medication cause?
Side effects are possible with stiripentol. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Difficulty coordinating
- Body part shaking that is uncontrollable
- Decline in muscular tone
- Having trouble speaking
- Variations in weight
Certain adverse effects can be very harmful. Call your doctor right away if you encounter any of these signs or any of the ones in the “SPECIAL PRECAUTIONS” section:
- Cough, sore throat, fever, chills, or other infection-related symptoms
- Significant bruising or bleeding
- Blood in the stools or urine
Weight loss and appetite loss are side effects of stiripentol. Call your doctor if you notice your kid is losing weight. Your doctor will keep a close eye on your child’s development. If you are worried about your child’s weight gain or growth while taking this medicine, discuss it with your doctor.
Further negative effects of stiripentol could exist. If you experience any strange issues while taking this medicine, contact your doctor right away.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from light, excessive heat, and moisture at room temperature (not in the bathroom).
Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org
Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.
What other information should I know?
Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to stiripentol, your doctor will request specific lab tests.
You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.