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RESTART now offers local deliveries. Do we deliver in your area? RESTARTDELIVERS.com
You may wonder how FDA Approved CBD or Pharmaceutical Grade CBD compares to other products made from cannabis, such as RESTART CBD. Here we look at how they are alike and different.
*(It’s important to note that CBD is CBD whether it’s from Marijuana or Hemp)
RESTART CBD refers to many different products that contain cannabinoids from hemp plants. These could include CBD and small amounts of tetrahydrocannabinol (THC). You can feel “high” or euphoric after using THC.
RESTART CBD may also contain other cannabinoids including CBN, CBG, THC etc. depending on the type of product and where it is purchased.
RESTART CBD products are sometimes used to help support health and well-being. Some people use these products to help increase calmness, improve focus, or reduce stress. It’s important to remember that the safety and effectiveness of RESTART CBD have not been proven.
It is worth mentioning that the only FDA approved CBD, pharmaceutical Grade CBD is not pure CBD – nor is it the same concentration of CBD found in all of the hemp products that have found their way to the U.S. market.
Their solution, derived from marijuana, is available only by prescription. It also contains “dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose,” according to drug maker GW Pharmaceuticals. AND, the CBD used in this medicine (purified 98% oil-based CBD extract) is derived from the cannabis plant.
It was approved by the Food and Drug Administration (FDA) in June 2018 and is the first FDA-approved drug made from cannabis. It is a brand-name prescription drug used to treat epileptic seizures. It contains cannabidiol (CBD) derived from marijuana which is why you need a prescription for it. (Marijuana is not federally legal). It comes as a liquid solution that’s taken by mouth. and is approved for use in adults and children ages 2 and older.
This product will not get you high as it only contains CBD and does not contain any THC, however it is considered a controlled substance and may cause dependence. (based on other ingredients in the product).
Therefore it is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that it has a low risk of being misused.
It contains the active ingredient cannabidiol (CBD).
As with all medications, the cost can vary. To find current prices for in your area, check out WellRx.com. Averages between $900-1000. Normally the cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance coverage and the pharmacy you use.
They say it can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking CBD. This list does not include all possible side effects.
The more common side effects of can include:
Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.
Serious side effects
Marijuana or Hemp: Forbes Article
In clinical studies, people taking higher doses of the “FDA Approved Pharmaceutical CBD” had reports of liver problems more often than people taking lower doses of CBD. Liver damage was the most common reason for people stopping use of it during clinical studies. If you have liver disease, you may have a higher risk of having liver damage while taking their product. Be sure to review your medical history with your doctor before taking CBD.
During treatment, your doctor will monitor you or your child closely for signs of new or worsening depression or unusual mood changes. Talk with your doctor right away if you notice these signs in yourself or your child, or if you have thoughts of harming yourself.
Typically, your doctor will start you or your child on a low dosage and adjust it over time to reach the dosage that works best. They’ll ultimately prescribe the smallest dosage that provides the desired effect.
The dosage your doctor prescribes will depend on several factors. These include:
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes. Your doctor will determine the best dosage to suit your or your child’s needs.
It’s available in a 100-mL bottle. Each mL of solution contains 100 mg of active drug.
You or your child will take the liquid solution using a plastic oral syringe. You use this device to measure the amount of medication, and to release the solution into your or your child’s mouth. This drug can be taken using a 1-mL or a 5-mL syringe. Your pharmacist will give you the right-sized syringe for your prescribed dose of.
As with all CBD products, this product is prescribed in doses of milligrams (mg) of medication per kilogram (kg) of body weight. One kilogram of body weight is equal to 2.2 pounds of body weight. Your dosage will be written as mg/kg.
Recommended (standard) dosages for people with seizures caused by Lennox-Gastaut syndrome or Dravet syndrome are listed below.
Your doctor may increase your dosage after you or your child takes the starting dose for one week. Dosages are increased depending on how well the drug is tolerated and if it’s working well.
Your doctor may prescribe a different dosage depending on several factors, including whether you have liver disease. If you have questions about the dosage that’s right for you, talk with your doctor
If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip your missed dose. Just take your next dose at the regular time.
If you are not sure about whether you should take a missed dose, call your doctor’s office.
Don’t take more than one dose at the same time. Doing this can increase your risk of serious side effects.
It’s meant to be used as a long-term treatment. If you and your doctor determines it to be safe and effective, you or your child will likely take it long term.
The Food and Drug Administration (FDA) approves prescription drugs such as this one to treat certain conditions. It may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.
The Pharmaceutical CBD is FDA-approved to treat seizures caused by two rare and severe forms of epilepsy:
These syndromes can be very difficult to treat. People with these forms of epilepsy often need more than one medication to reduce the number of seizures they have.
It is approved for use in adults and children ages 2 and older with these conditions.
It was the first FDA-approved drug made with cannabidiol (CBD). It’s only approved to treat seizures caused by Dravet syndrome and Lennox-Gastaut syndrome.
Many studies are looking at other ways CBD could be used for medical treatment. Some of these possible uses are described below.
It isn’t approved to treat pain. Animal studies have shown that CBD may help relieve pain. However, fewer studies have looked at the safety and effectiveness of CBD for treating pain in humans. For more information, see the “treating pain” section below.
It isn’t approved to treat anxiousness. However, several studies have shown that CBD may improve anxiousness by reducing anxious feelings during stressful times.
It hasn’t been proven safe or effective for treating anxiousness. Only use as directed by your doctor.
It isn’t approved to treat autism. Only a few studies have looked at using CBD to treat autism. In one clinical study of children with autism, CBD reduced symptoms of:
It hasn’t been proven safe or effective for treating autism. Only use as directed by your doctor.
For schizophrenia
It isn’t approved to treat schizophrenia. In several small studies, CBD reduced schizophrenia symptoms in some people. However, other studies haven’t shown an improvement in symptoms after treatment with CBD.
It hasn’t been proven safe or effective for treating schizophrenia. Only use as directed by your doctor.
It is not approved to treat or prevent migraine. Few studies have looked at the use of CBD for migraine treatment.
In some clinical studies, CBD helped to reduce the number of migraine headaches in people using the drug. In these studies, CBD was used in combination with tetrahydrocannabinol (THC).
Similar to CBD, THC is a compound that comes from marijuana. THC can cause you to feel “high” or euphoric. These effects aren’t caused by CBD.
It hasn’t been proven safe or effective for treating migraine. Only use as directed by your doctor.
It isn’t approved to treat infantile spasms. Only one small clinical study looked at using CBD to treat this condition. For almost all of the infants in the study, CBD didn’t improve their symptoms.
It hasn’t been proven safe or effective for treating infantile spasms. Only use as directed by your doctor.
it isn’t approved to treat tuberous sclerosis. However, in one small clinical study, the following results were seen in people with this condition:
People in this study taking CBD in combination with a seizure drug called clobazam had even fewer seizures during treatment.
It hasn’t been proven safe or effective for treating tuberous sclerosis. Only use it as directed by your doctor.
It isn’t approved to treat multiple sclerosis (MS). There isn’t much known about using CBD alone to treat MS.
Several studies have looked at using a combination of CBD and tetrahydrocannabinol (THC) to treat MS. Similar to CBD, THC comes from marijuana. However, THC can cause you to feel “high” or euphoric. These side effects aren’t caused by CBD.
In studies of people with MS taking CBD and THC, some symptoms improved during treatment. Symptoms that improved included:
It hasn’t been proven safe or effective for treating MS. Only use as directed by your doctor.
It is FDA-approved for use in children to treat seizures caused by Lennox-Gastaut syndrome or Dravet syndrome. It can be given to children ages 2 years and older.
It isn’t FDA-approved to treat pain. But it is made from cannabidiol (CBD). This compound is a drug that comes from marijuana (cannabis). CBD has been studied as a treatment for pain in both animals and humans.
The exact way that CBD reduces pain isn’t known. It’s thought that CBD blocks certain pain signals traveling through the body’s nerves. This may help to reduce the pain you actually feel. CBD also helps to stop inflammation that can happen after nerves are irritated by pain.
Several animal studies have looked at using CBD to treat pain. In these studies, CBD reduced pain in animals that had nerve pain caused by chemotherapy (a type of cancer treatment) or joint pain caused by arthritis.
One small study looked at using CBD to treat people with pain caused by nerve disease or nerve damage. People in this study were given either CBD, THC (a drug that also comes from cannabis), CBD together with THC, or a placebo (no treatment). The results showed the following:
Many other studies have found that the combination of CBD and THC helps to reduce pain caused by some diseases and injuries. More research is needed to know if CBD treatment alone reduces pain.
FDA-approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. These rare but severe conditions usually appear in early childhood or infancy.
It was tested in clinical trials. Its active ingredient, cannabidiol, is currently being tested in clinical trials for other uses.
In clinical trials, people with Lennox-Gastaut syndrome who were treated had fewer seizures than people who did not take the drug. During the 14-week study:
Another clinical trial lasting 14 weeks looked at people with Dravet syndrome. This trial included children and teenagers. People who took it had 26% fewer seizures than people who did not take the drug. The dosage given in this trial was 20 mg/kg daily.
All of the people in both of these clinical trials were taking it in combination with other epilepsy drugs. Examples of epilepsy medications given include:
Cannabidiol (the active drug) is currently being tested in clinical trials as a treatment option for other conditions. Research is being done for the following conditions:
Many ongoing studies for other conditions are also being done. If you’d like to participate in a study, look for clinical trials in your area at clinicaltrials.gov.
Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative, talk to your doctor to learn more about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions.
Treatment guidelines recommend the following drugs to treat Lennox-Gastaut syndrome:
Some experts recommend the following drugs to treat Dravet syndrome:
It is commonly prescribed with other drugs when used to treat seizures. Many of the drugs listed above can be used in combination. Your doctor will recommend which drugs can be used together based on your condition.
It is FDA-approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. It’s the only drug containing cannabidiol (CBD) that’s approved for medical use by the FDA.
The quality, safety, and effectiveness of a drug can be ensured by FDA-approval. Because it has been approved by the FDA, you can be assured that the drug:
Other products made with CBD are available to purchase, but they haven’t been approved by the FDA. This means that the FDA can’t guarantee that those products have a safe amount of CBD. It also means the effectiveness of those products hasn’t been tested.
One study looked at products containing CBD that were not FDA-approved. The study found that only 31% of those products contained the amount of CBD listed on their label. Of the remaining 69% of products:
The labels for these products didn’t state that they contained tetrahydrocannabinol (THC). However, about 21% of the products did contain THC. This chemical is found in marijuana (cannabis). THC can make you feel “high” or euphoric.
Certain U.S. states have laws that require products containing CBD to be tested before they’re sold. States that haven’t made marijuana (cannabis) legal for medical or recreational use don’t have these laws. This means that products containing CBD might not be tested before they’re sold in some areas of the United States.
Be sure you’re familiar with state laws before you purchase any products containing CBD. This will help you make sure that you buy products from safe and reputable companies that have had their products tested.
it can interact with several other medications. It can also interact with certain supplements as well as certain foods.
Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Below is a list of medications that can interact with it. This list does not contain all drugs that may interact.
Before taking any drug, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Taking it with certain seizure medications can increase the risk of side effects and change how the medications work.
Some examples of interactions with seizure medications include:
There may be other seizure medications in addition to these that can interact. Be sure to tell your doctor and pharmacist about all of the medications you are taking for seizure control. This will help prevent dangerous side effects and make sure the drugs are as effective as possible.
Taking it with certain antiviral medications can change levels of either drug in the body. This can make the medications more or less effective. It can also increase the risk of side effects.
Examples of antiviral drugs that may interact include:
Many of these drugs are part of combination tablets (tablets made from more than one drug). Be sure to tell your doctor or pharmacist about all of the antiviral medications you are taking. This will help make sure the drugs are as effective as possible and will help you avoid dangerous side effects.
Taking it with certain antifungal medications can increase the risk of side effects. Examples of these antifungal drugs include:
Talk with your doctor or pharmacist about all antifungal medications you take. They can make sure the drugs won’t interact with it. This will help you decrease your risk of certain side effects.
Taking it with certain herbs or supplements, such as St. John’s wort, can lower CBD levels in your body. This may reduce how effective it is in treating seizures.
Other herbs and supplements can make you feel extra drowsy or sleepy if they’re taken with it. Examples of these include:
Talk with your doctor about any herbs or supplements you take. They may recommend that you stop taking certain products that cause drowsiness and products that affect how well it works for you.
Eating meals with large amounts of fat or calories can increase the amount of CBD that your body absorbs. This can increase your risk of side effects, such as drowsiness, diarrhea, rash, and trouble sleeping.
It’s important to eat similar amounts of fat and calories at each meal. This will help keep a stable level of CBD in your body and reduce your risk of side effects. If you have questions about your diet, talk with your doctor.
Don’t stop taking Pharmaceutical Grade CBD without talking with your doctor. Stopping it suddenly can cause increased seizures and a dangerous condition called status epilepticus. If you and your doctor decide that you or your child should stop taking it, your doctor will slowly reduce the dosage to avoid these effects.
You or your child should take it according to your doctor or healthcare provider’s instructions.
It is taken twice daily. It’s best to take the doses about 12 hours apart.
it can be taken with or without food.
Keep in mind, eating foods high in calories or fat can increase the amount of CBD that the body absorbs. This can increase the risk of side effects.
Try to eat similar amounts of fat and calories at each meal. This will help keep the level consistent in your or your child’s body.
It comes with two reusable plastic oral syringes. You’ll use these syringes to measure the exact dose of medication you’re prescribed, and to take the medication into your or your child’s mouth.
You’ll be given two syringes so that you have an extra syringe in case you misplace one. You shouldn’t take it with syringes from another medication. Be sure to only use the syringes that come with the product.
Two different syringe sizes are available: 5 mL and 1 mL. Your pharmacist will give you the right one for your or your child’s dose.
Don’t use a household measuring device (such as a teaspoon) to measure the dose. These devices don’t always measure the exact amount you need. If you lose the syringes that come with the product, ask your pharmacist for new ones.
When using a new bottle, follow these steps:
It is approved to treat seizures caused by two forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
It contains the drug cannabidiol (CBD), which comes from marijuana (cannabis). Unlike THC, another compound in marijuana, CBD doesn’t make you feel “high” or euphoric.
It’s not known exactly how it reduces the number of seizures people have. During a seizure, the brain sends abnormal electrical signals. It may work on certain pathways in the brain to prevent these signals from starting and spreading.
It typically starts working within days to weeks. In clinical studies, many people had fewer seizures within four weeks of starting treatment.
It isn’t known if CBD is safe to use during pregnancy. Animal studies have shown harm to a growing fetus when the pregnant mother took CBD. However, animal studies don’t always predict what will happen in humans.
If you are pregnant or may become pregnant, talk with your doctor about the benefits and risks of taking CBD in pregnancy.
If you take CBD during pregnancy, you’re encouraged to enroll in a pregnancy registry. The North American Antiepileptic Drug Pregnancy Registry studies how pregnant woman and their babies are affected by epilepsy drugs.
Contact the registry at 888-233-2334 or visit the registry’s website.
It’s not known if CBD passes into breast milk. If you are breastfeeding and considering taking CBD, talk with your doctor. You can discuss the risks and benefits of using CBD while breastfeeding.
This means it can cause dependence, and its use is regulated by the federal government.
It is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that it has a low risk of being misused.
It is the only FDA-approved medication made from CBD. All other drugs made with CBD are classified as schedule one (I) drugs. They’re not approved by the FDA for medical treatment. However, in some U.S. states, it’s legal to use these products for medical use.
If you travel to other U.S. states and use CBD, it helps to be familiar with the legal status of CBD in those states. It is legal for use in all states if you have a prescription for it. However, some other CBD products may still be illegal in many states.
The U.S. government has special rules in place for all controlled substances. These rules help ensure safety when controlled drugs are prescribed and dispensed. If you’d like to know more about how controlled substances are handled, talk with your doctor or pharmacist.
All controlled substances, need to be stored in a safe, secure place. Carefully storing this drug will help prevent it from being used accidentally by other people (or pets). It will also help prevent anyone from trying to misuse the drug.
Here are answers to some frequently asked questions about CBD.
Pharmaceutical Grade CBD is classified as a schedule five (V) prescription drug. Drugs with a higher classification (such as schedule five drugs) have a lower risk of being misused than drugs with a lower classification (such as schedule one drugs). This means that it has a low risk of being misused.
It the only FDA-approved medication made from cannabidiol (CBD). The quality, safety, and effectiveness of a drug can be ensured by FDA-approval. Because it has been approved by the FDA, you can be assured that the drug:
All other drugs made with CBD are classified as schedule one (I) drugs. These drugs are not approved by the federal government for medical treatment. However, in some U.S. states, it’s legal to use these products for medical use.
No, it doesn’t make you feel “high” or euphoric.
It contains a drug called cannabidiol (CBD). This drug comes from marijuana (cannabis). It doesn’t make you feel intoxicated. Tetrahydrocannabinol (THC) is a drug that also comes from marijuana (cannabis). THC can make you feel “high.”
It doesn’t contain any THC. It only contains CBD.
Yes, it’s legal to use marijuana grade CBD if your doctor has prescribed it for you or your child.
Yes, you can use it if you’re on a ketogenic diet. But you should talk with your doctor about how your diet can affect the medication. Eating meals high in fat can increase the amount of CBD that your body absorbs. This can increase the level of CBD in your system.
In clinical studies, CBD levels were increased up to five times when the drug was taken with a high-fat meal.
Higher levels of CBD in the body can increase your risk of side effects. These can include:
If you’re on a ketogenic diet, your doctor will monitor your side effects. They may recommend a different dose of CBD or changes in your diet.
In total, 1,756 people took it during clinical studies. About 1% of people in the clinical studies died.
It was not found to be the cause of death in these people. Many of those who died had several complicated diseases. Some of these diseases increase the risk of death.
Also, the number of deaths in these studies was similar to the number of deaths in people who have either Lennox-Gastaut syndrome or Dravet syndrome.
Before taking, talk with your doctor about any medical conditions you have. It may not be right for you if you have certain conditions. These include:
Taking too much can increase your risk of serious side effects.
Symptoms of an overdose can include:
If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. If your symptoms are severe, call 911 or go to the nearest emergency room right away.
When you get it from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.
The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.
How long a medication remains good can depend on many factors, including how and where you store the medication.
The solution should be stored at room temperature. Make sure to keep the bottle standing upright and the lid tightly closed. Do not freeze the medication.
You can use it for 12 weeks (three months) after the bottle is first opened. Discard any medication that’s left over after the bottle has been open for 12 weeks. This is due to the use of the sesame seed oil. RESTART CBD uses MCT oil which has a 2 year shelf life.
If you no longer need to take it and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.
The following information is provided for clinicians and other healthcare professionals.
FDA approved CBD for the following indications:
It is approved for use in people ages 2 years and older.
The mechanism of action in treating epilepsy is not clear. However, it appears that the anticonvulsant activity is not related to interaction with cannabinoid receptors in the body.
At steady state, it reaches maximum concentration in 2.5 to 5 hours. High-calorie or high-fat meals increase maximum concentration 5-fold, compared to concentration after administration in a fasted state.
Protein binding of the parent drug and metabolites is greater than 94%.
It is extensively metabolized by the liver. Metabolism occurs via CYP2C19, CYP3A4, UGT1A7, UGT1A9, and UGT2B7. Moderate to severe hepatic impairment increases blood plasma levels 2.5-fold to 5.2-fold.
The half-life of is between 56 and 61 hours. Elimination occurs primarily in the feces, with significantly less excretion in the urine.
It is contraindicated in patients with a history of hypersensitivity to cannabidiol or any of the components.
It is contraindicated in patients with a history of hypersensitivity reaction to sesame seed oil.
Classified by the federal government as a schedule five (V) drug, which has the lowest abuse and addiction potential compared to other drug schedules.
In clinical studies, there were no reports of abuse or dependence.
As with all anti-epileptic drugs, abrupt withdrawal should be avoided due to potential for increased seizure frequency and status epilepticus. Gradual titration is recommended.
Store in an upright position and at room temperature (68°F to 78°F, or 20°C to 25.6°C) with the cap tightly closed. Do not freeze. Discard any unused solution 12 weeks after first opening.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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