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Seizures are shared. Now hope is too. Experience the possibility of significant seizure reduction with EPIDIOLEX, the 1st and only FDA-approved prescription CBD used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. See Important Safety Information. Prescription CBD Oil Chris Aiken, MD Editor-in-Chief of The Carlat Psychiatry Report . Practicing psychiatrist, Winston-Salem, NC. Dr. Aiken has disclosed that he has no relevant

Seizures are shared.
Now hope is too.

Families share everything. For many, that includes the fears and frustrations of living with seizures. With seizure reduction from EPIDIOLEX, families can now share something else: hope.

EPIDIOLEX is the first and only FDA-approved prescription cannabidiol (CBD) to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age or older.

EPIDIOLEX results

EPIDIOLEX significantly reduced seizures in people living with LGS, Dravet syndrome, or TSC for whom multiple previous antiseizure medicines did not work well.

Getting started on EPIDIOLEX

Learn about getting your prescription and the insurance process, dosing, administration, and more.

Helpful resources

Learn more about CBD, and download a doctor discussion guide and other helpful tools and worksheets, including dosing and medication guides.

A series about navigating the complexities of living with epilepsy

Greg Grunberg hosts The Care Giver

Join Greg, actor and advocate for his son living with epilepsy, as he travels across the country to help tell the stories of caregivers of families living with rare forms of epilpesy. The caregivers get an unforgettable day of care and Greg gets to learn about their challenges and hopes along the way. The Care Giver series is full of incredible stories of caregivers from diagnosis to starting on EPIDIOLEX that will provide you strength and hope in knowing you’re not alone on this journey.

Important Safety Information

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…

Indications

What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex … in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Important Safety & Indications Important Safety Information & Indications

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?

Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX :

  • loss of appetite, nausea, vomiting
  • fever, feeling unwell, unusual tiredness
  • yellowing of the skin or the whites of the eyes (jaundice)
  • itching
  • unusual darkening of the urine
  • right upper stomach area pain or discomfort

EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.

Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.

Take EPIDIOLEX exactly as your healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause serious problems.

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What Else Should I Know When Taking EPIDIOLEX?

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

What Additional Information Applies to Women?

If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.

If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.

What is EPIDIOLEX (cannabidiol)?

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Jazz Pharmaceuticals at 1-833-424-6724.

Important Safety Information

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?
Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX. EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if…

Indications

What is EPIDIOLEX (cannabidiol)?
EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex … in patients 1 year of age and older. It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Important Safety & Indications Important Safety Information & Indications

What is the Most Important Information I Should Know About EPIDIOLEX (cannabidiol)?

Do not take if you are allergic to cannabidiol or any of the ingredients in EPIDIOLEX.

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX :

  • loss of appetite, nausea, vomiting
  • fever, feeling unwell, unusual tiredness
  • yellowing of the skin or the whites of the eyes (jaundice)
  • itching
  • unusual darkening of the urine
  • right upper stomach area pain or discomfort

EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.

Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any signs of depression or anxiety, thoughts about suicide or self-harm, feelings of agitation or restlessness, aggression, irritability, or other unusual changes in behavior or mood, especially if they are new, worse, or worry you.

Take EPIDIOLEX exactly as your healthcare provider tells you. Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine suddenly can cause serious problems.

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What Else Should I Know When Taking EPIDIOLEX?

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

EPIDIOLEX may affect the way other medicines work, and other medicines may affect how EPIDIOLEX works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

What Additional Information Applies to Women?

If you are pregnant or plan to become pregnant, EPIDIOLEX may harm your unborn baby. You and your healthcare provider will have to decide if you should take EPIDIOLEX while you are pregnant.

If you become pregnant while taking EPIDIOLEX, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (by calling 1-888-233-2334). The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy.

Because many medicines like EPIDIOLEX are passed into breast milk, talk to your healthcare provider about the best way to feed your baby while taking EPIDIOLEX.

What is EPIDIOLEX (cannabidiol)?

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

It is not known if EPIDIOLEX is safe and effective in children under 1 year of age.

Please refer to the EPIDIOLEX Medication Guide and Instructions for Use for additional important information.

Prescription CBD Oil

Chris Aiken, MD

Editor-in-Chief of The Carlat Psychiatry Report. Practicing psychiatrist, Winston-Salem, NC.

Dr. Aiken has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.

Your patient comes in with a new medication on his list: CBD oil. He started taking it for anxiety and wants to know if it’s safe. You hedge, explaining that there is limited information available on unregulated products, but the patient is persistent. He says CBD oil is available as a prescription, and wonders if you could write one for it.

Cannabidiol, or CBD, is a derivative of marijuana that has recently become available as a prescription drug, Epidiolex. It is FDA-approved for two rare forms of childhood epilepsy, Lennox-Gastaut and Dravet syndromes, and was fast-tracked for that indication because of the dire need for treatment in children with these intractable seizures. Meanwhile, the same drug has been available as a supplement for the past decade, called CBD oil. Many patients take this oil for its rumored mental health benefits, and you’ll need to know the basics when they request prescriptions for it.

Table: Cannabinoids From CBD to THC

CBD vs THC
Marijuana (cannabis) is a blend of over 100 cannabinoids, only one of which is tetrahydrocannabinol (THC), the cannabinoid that is most responsible for the high people get from consuming pot. CBD, on the other hand, does not cause a “high,” although many people consider it to be somewhat tranquilizing. CBD also does not cause some of the problems seen with THC, such as cognitive impairment, anxiety, and (more rarely) psychosis. Those dangers are particularly relevant to adolescents, where the latest data show that marijuana triples the risk of psychotic disorders (Jones HJ et al, JAMA Psych 2018;75(3):240–246). CBD has neuroprotective properties, and it may actually lower the risk of psychosis and anxiety with THC. For more information, see the table “Cannabinoids From CBD to THC” above.

CBD in psychiatric disorders
In one of the most paradoxical clinical findings in recent memory, it turns out that CBD, far from causing psychosis, may actually be an effective treatment for psychosis. So far, 5 out of 7 controlled trials of CBD’s antipsychotic effects have been positive, and the latest of these is reviewed in this issue (Epidemiol Psychiatr Sci 2018;27(4):327–335). Another prescription CBD product, Arvisol, is undergoing phase I clinical trials in schizophrenia.

In addition to psychosis, there are a couple of small, placebo-controlled trials of CBD in social anxiety disorder. These looked at the drug’s acute effects when taken before a stressful social situation in 34 subjects. Compared to placebo, CBD had a significant effect, bringing anxiety down to the same levels reported by healthy controls (Blessing EM et al, Neurotherapeutics 2015;12(4):825–836).

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Somnolence is the main side effect with CBD, but studies in sleep are mixed. Tolerance can develop to its sedative effects, and low doses (below 160 mg) can be stimulating (Babson KA, Curr Psychiatry Rep 2017;19(4):23). CBD does not appear to help bipolar mania or the cognitive impairments of schizophrenia.

CBD oil or Epidiolex?
Are CBD oil and Epidiolex really the same drug? They are both CBD, short for cannabidiol, but where they differ is in their purity and regulatory status. Epidiolex is a Schedule V prescription drug, the lowest level of regulation for a controlled substance. CBD oil is an ­over-the-counter supplement. It is legal in all states as long as it’s extracted from the hemp plant, a variety of cannabis that contains little THC and produces no high.

In terms of purity, CBD oil is a gamble. In a study of 84 online products, only 30% contained the amount of CBD on the label, and 21% contained THC (Bonn-Miller MO et al, JAMA 2017;318(17):1708–1709). The FDA keeps a running tally of unacceptable products at www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm. Another good source is Consumer Labs, which tests products for purity and integrity. Among their recommended options, the best-priced oils are available at elixinol.com and bluebirdbotanicals.com.

The dosages used in psychiatric research range from 300 mg/day for anxiety to 800–1,200 mg/day for schizophrenia. The epilepsy dosage, 10–20 mg/kg/day, adds up to around the same amount used in schizophrenia for most adults. Cost is an issue with CBD, prescribed or not. A 300 mg dose is $20–50/day in the over-the-counter form and around $35/day for the prescription when paying out of pocket.

CBD, Marinol, and medical marijuana
CBD is in a very different category than dronabinol (Marinol) and nabilone (Cesamet), the other prescription cannabinoids. These are synthetic isomers of THC (Δ-9-THC) and are under tighter regulation than CBD (Schedule III vs Schedule V). They are only approved for nausea during chemotherapy and, in the case of dronabinol, anorexia in AIDS. As pure THC compounds without the protective effects of CBD, they may have even more psychedelic effects than marijuana (Bhattacharyya S et al, Neuropsychopharm 2010;35(3):764–774). “Medical marijuana” can refer to any marijuana component, such as CBD, or to the plant itself. It usually refers to the plant, which is legal with a prescription in 33 states and Washington DC. Each state has its own list of conditions that medical marijuana is approved for.

Side effects and drug interactions
The World Health Organization concluded that CBD has “a good safety profile” (WHO, 2018). Somnolence is its main side effect, and the PDR warns of elevated liver enzymes. On drug screens, CBD can cause a false positive for THC.

CBD may raise the levels of psychiatric medications through inhibition at UGT2B7 (lamotrigine, lorazepam) and CYP2C19 (diazepam and several SSRIs and antipsychotics). CBD itself is metabolized by CYP3A4 and CYP2C19.

Risks vs benefits
The FDA fast-tracked the approval of Epidiolex (CBD) because its risk-benefit profile is favorable for rare forms of epilepsy that are difficult to control with current anticonvulsants. The bar is higher for disorders with existing treatments, like psychosis and anxiety, and the data in these conditions are scarcer.

While we sort out these dilemmas, patients will no doubt experiment with the readily available CBD oil, so what should we do in the interim? We recommend the following commonsense approach.

TCPR Verdict: We don’t have much evidence to endorse or warn against CBD. Though it’s premature to prescribe CBD, we should guide patients to safer products if they are getting it on their own. That’s harm reduction, like suggesting to casual drinkers that red wine is safer than vodka

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