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DESCRIPTION
EpidioLex (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Epidiolex (100 mg/mL) (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This medication is used to treat seizures due to certain medical conditions (such as Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex – TSC).
How to get epidiolex
It is not known how this medication works for these seizures. Cannabidiol belongs to a class of drugs known as cannabinoids. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.
How to use Epidiolex
Read the Medication Guide and Instructions for Use provided by your pharmacist before you start taking cannabidiol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually twice daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.
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The dosage is based on your medical condition, weight, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose.
Also, if you are directed to stop taking this medication, your doctor may decrease your dose gradually. Follow your doctor’s instructions carefully. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
How To Store Epidiolex
Store in the original bottle at room temperature away from light and moisture. Keep the bottle tightly closed and in an upright position. Do not refrigerate or freeze. Do not store in the bathroom. Keep all medications away from children and pets. Use/discard this medication within 12 weeks after opening the bottle.
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Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
WARNINGS & PRECAUTIONS
Hepatocellular Injury:
EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Transaminase and bilirubin levels should be obtained prior to starting treatment, at one, three, and six months after initiation of treatment, and periodically thereafter, or as clinically indicated.
Resolution of transaminase elevations occurred with discontinuation of cannabidiol , reduction of cannabidiol and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of cannabidiol or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment.
Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury.
Somnolence and Sedation:
EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.
CONTRAINDICATION: HYPERSENSITIVITY
cannabidiol oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.
PREGNANCY:
EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking cannabidiol during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
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