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Epidiolex (Generic Cannabidiol)

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Why is this medication prescribed?

Cannabidiol is used to treat seizures in adults and children aged one year and up who have tuberous sclerosis complex (TSC; a genetic condition that causes tumors to grow in many organs), Dravet syndrome (a disorder that starts in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking), or Lennox-Gastaut syndrome (a disorder that causes seizures, behavioral issues, and developmental delays). Cannabidiol belongs to a group of drugs known as cannabinoids. The precise mechanism by which cannabidiol inhibits seizure activity is unknown.

How should this medicine be used?

Cannabidiol is administered orally as a liquid solution. Usually, it is taken twice a day. You should take cannabidiol consistently, regardless of whether you take it with or without food. Take cannabidiol daily at approximately the same times. Pay close attention to the instructions on the label of your prescription and ask your pharmacist or doctor to explain anything you do not understand. Cannabidiol should be taken as prescribed. Never take more or less of it, or take it more frequently than your doctor has instructed.

To measure the solution, use the oral syringe that was included with the prescription. To measure your dosage, never use a regular spoon.

Take the drug every time you take it using a dry oral syringe. If water gets inside the syringe or into the medicine bottle, the solution can become hazy, but this won’t affect the medication’s effectiveness or safety.

With a feeding tube, the oral solution can be administered. Consult your doctor about the proper way to take your medication if you are on a feeding tube. Pay close attention to these instructions.

Cannabidiol will be prescribed to you by your doctor at a low dosage and increased gradually over time, usually no more than once per week.

Although it doesn’t heal your illness, cannabidiol aids in its management. Keep taking cannabidiol even if you feel better. Consult your physician before quitting cannabis. You can get new or worsening seizures as a result of withdrawal symptoms if you abruptly stop using cannabidiol. Most likely, your doctor will gradually reduce your dosage.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with cannabidiol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Other uses for this medicine

Cannabidiol is used to control seizures. However, there may be off-label or investigational uses of Cannabidiol that your healthcare provider may consider based on your individual medical situation. It’s important to discuss any potential off-label use with your healthcare provider.

What special precautions should I follow?

Regarding special precautions for Cannabidiol:

  • In case you have any allergies to sesame seed oil, other drugs, cannabidiol, or any of the substances in the cannabidiol solution, let your doctor and pharmacist know. For an ingredient list, ask your pharmacist or consult the Medication Guide.
  • Inform your physician and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal remedies you now take or intend to use. Don’t forget to bring up any of these: antidepressants; anxiety drugs; bupropion (Aplenzin, Zyban); caffeine; carbamazepine (Carbatrol, Equetro, Tegretol, Teril); cimetidine (Tagamet); clarithromycin (in Biaxin); clobazam (Onfi); diazepam (Diastat, Valium); diflunisal; diltiazem (Cardizem, Cartia, Taztia, others); efavirenz (Sustiva); erythromycin (E.E.S, Eryped, Ery-tab); esomeprazole (Nexium); felbamate (Felbatol); fenofibrate (Antara); fluoxetine (Lopid); indinavir (Crixivan); isoniazid (Laniazid, in Rifater); itraconazole (Onmel, Sporanox); ketoconazole; lamotrigine (Lamictal); morphine (Astramorph, Kadian); nefazodone; nelfinavir (Viracept); nevirapine (Viramune); omeprazole (Prilosec); pantoprazole (Protonix); phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, in Rifamate, in Rifater); ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; antiemetic drugs; ticlopidine; tranquilizers; valproate (Depacon); verapamil (Verelan); and voriconazole (Vfend). Your doctor might need to carefully monitor you for any negative effects or adjust the dosages of your medications. Tell your doctor about all the medications you use, even ones that are not on this list, as many other medications may also interact with cannabidiol.
  • Inform your physician of all the herbal supplements you use, particularly St. John’s Wort.
  • Inform your physician if you use or have used excessive amounts of prescription drugs, alcohol in excess, or street drugs in the past. Additionally, let your doctor know if you currently have liver illness, depression, mood disorders, suicidal thoughts or actions, or any of the above.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Contact your physician if you become pregnant while using cannabis.
  • You should be aware that cannabidiol might impair your ability to focus or make you feel sleepy. Till you are certain of how this medication will affect you, do not operate machinery or drive a car.
  • Find out from your doctor if drinking alcohol is safe for you while taking cannabidiol. Some of the negative effects of cannabidiol may worsen if you drink alcohol.
  • Be aware that while taking cannabidiol, your mental health may alter in unexpected ways and you may experience suicidal thoughts (thinking about hurting or killing oneself, preparing to do so, or trying to do so). Approximately 1 in 500 adults and children aged five and above who were prescribed anticonvulsants for a variety of ailments during clinical trials experienced suicide thoughts while undergoing treatment. There is a chance that using an anticonvulsant drug like cannabidiol could cause changes in your mental state, but there is also a chance that not treating your disease will cause changes in your mental state. The question of whether taking an anticonvulsant medicine carries more hazards than not taking it will be decided by you and your doctor. If you have any of the following symptoms, you, your family, or your caretaker should contact your doctor as soon as possible: panic attacks; agitation or restlessness; unexpected changes in behavior or mood; acting on dangerous impulses; trouble falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; obsessing over death and dying; parting with priceless possessions; or any other unusual changes in behavior or mood. If you are unable to get treatment on your own, make sure your family or caregiver knows which symptoms could be significant so they can call the doctor.

Always follow your healthcare provider’s instructions and guidance regarding the use of Entereg, and do not hesitate to ask any questions or express any concerns you may have about the medication.

What special dietary instructions should I follow?

If you plan to consume or drink grapefruit juice while taking this medicine, consult your doctor.

What should I do if I forget a dose?

As soon as you recall, take the missed dose. On the other hand, if the next dose is almost here, skip the one you missed and stick to your usual dosage plan. Never take two doses to make up for something you forgot to take.

What side effects can this medication cause?

Cannabidiol can cause various side effects, ranging from mild to severe. Common side effects may include:

  • Diarrhea
  • Tiredness
  • Difficulty falling asleep or staying asleep
  • Loss of appetite
  • Weight loss
  • Stomach pain or discomfort
  • Drooling or excessive saliva
  • Problems with walking

Less common but potentially serious side effects of Cannabidiol include:

  • Rash
  • Hives
  • Redness
  • Loss of appetite; nausea; vomiting; yellow skin or eyes; itching; unusual darkening of the urine; or right upper stomach area pain or discomfort
  • Fever, cough, or other signs of infection

Cannabidiol might have further negative effects. If you have any odd side effects while taking this medicine, contact your doctor.

It’s essential to report any unusual or concerning symptoms to your healthcare provider promptly. They can help determine whether the side effects are related to Cannabidiol and provide appropriate guidance or treatment. Additionally, always follow your doctor’s instructions for taking Cannabidiol and inform them of any pre-existing medical conditions or medications you’re taking to minimize the risk of adverse reactions.

What should I know about storage and disposal of this medication?

When it comes to storage and disposal of Cannabidiol, here’s what you should know:

  • Storage: Keep this medication out of children’s reach and in the sealed container it came in. Keep it out of the bathroom and at room temperature, away from sources of heat and moisture. Don’t freeze or chill the solution. After opening the bottle, discard any leftover oral solution that is not in use within 12 weeks.
  • Disposal: Dispose of Cannabidiol properly according to local regulations or guidelines. Do not flush it down the toilet or drain unless instructed to do so. Ask your pharmacist or healthcare provider about the proper disposal method for unused or expired medication.

In case of emergency/overdose

In case of emergency or overdose of Cannabidiol:

  • Seek Medical Help: If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
  • Poison Control: You can also contact your local poison control center for guidance on what to do in case of overdose.

What other information should I know?

  • Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to cannabidiol.
  • Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking cannabidiol.
  • Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is crucial that you maintain a written record of every medication you take, including over-the-counter (OTC) and prescription drugs, as well as any dietary supplements, vitamins, and minerals. This list should accompany you to all doctor appointments and hospital admissions. Additionally, having this information on hand is crucial in case of an emergency.

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