DRONABINOL

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Created Jun 2019 | Updated Nov 2020

DRONABINOL

  • [SYNDROS]
  • [MARINOL]
  • [REDUVO]
  • [ADVERSA]

(-)-trans-delta9-tetrahydrocannabinol

DEA CODE 7365: Schedule 2

Marinol
Marinol is an FDA-approved medication with the active ingredient, dronabinol, a synthetic form of THC (delta-9-tetrahydrocannabinol) used to treat chemotherapy-induced nausea and vomiting treatment, as well as anorexia related to weight loss in patients with AIDS. THC is a natural component of the marijuana plant cannabis sativa, and it's psychoactive, which means it attaches to chemical receptors in your brain and produces a feeling of euphoria, or what we call a "high."

Marinol is approved by the FDA for medical uses, whereas marijuana has not been approved for any medical use at all at the federal level. Additionally, Marinol, or dronabinol, does not contain all the components of the full marijuana plant. The medication has a synthetic version of THC (delta-9-tetrahydrocannabinol), one of over 60 cannabinoids found in Cannabis sativa. Two cannabinoids in marijuana have been studied for medicinal uses: THC and cannabidiol. The use of medical marijuana for cancer pain is very controversial as it hasn't been well studied. However, severe or chronic pain accounts for more than 90% of the qualifying conditions for use of medicinal marijuana among registered users in the states in which it is legal. While there have only been a few studies done, it appears that smoking marijuana along with traditional pain medications for patients with cancer-related pain may be effective.

Marinol (dronabinol) has been studied for post-surgical pain, nerve-related pain, and chronic non-cancer pain. For the first two types of pain, Marinol was not found to be any better than placebo. For chronic non-cancer pain, it has been found to be only slightly better than placebo.

Dronabinol vs. Cannabis: What's the Difference?
In 1985 MARINOL (known as dronabinol in its generic form) was released into the pharmaceutical market. It was approved for use in 1985 as a way to treat weight loss for AIDS patients and to treat nausea and vomiting in chemotherapy patients across the nation. However, something about this product stood out considerably compared to other similar products on the market - this FDA approved product was composed of synthetic THC molecules. Dronabinol is a synthetic form of cannabis.

Most cannabis enthusiasts have encountered a 'THC overdose' at one time or another when they first began their use of the plant. The most common experiences caused by an overindulgence of THC are the inability to sleep, rapid heartbeat, and paranoid thoughts. However, after a few hours these effects go away and people are able to resume their normal activities. With dronabinol it's a completely different story. To start, swallowing a pill full of dronabinol is less effective than smoking a joint. But even though this method of ingestion is less effective, the side effects can be much more severe. The psychoactive side effects of dronabinol can be much more harsh and prolonged than that of the cannabis plant.

It has been known to cause short term memory loss, weakness, heart palpitations, abdominal pain, nausea, vomiting, dizziness, and abnormal thinking as a common side effect. More severe side effects include eye problems, muscle pain, speech problems, ringing in the ears, low blood pressure, and incontinence.

The bottom line is that dronabinol only manages to capture a few of the benefits associated with the cannabis plant and causes a lot of issues that the majority of cannasuers will never have to worry about.

With dronabinol, patients only have one form of medication they can use to treat their condition. With cannabis, there are a multitude of different strains and product variations that a patient can choose from to treat their medical condition. Cannabis consumers have the option of choosing their THC to CBD ratio with strains and products falling all along the spectrum. The array of cannabis products can be smoked, vaporized, eaten, rubbed, sprayed, and more.

Dronabinol is extremely expensive. A pack of 60 capsules with a 10 mg strength (600 mg total) are available for sale for about $2,620.00. In contrast, you can walk into a dispensary and buy a pre-rolled joint with 1 g of cannabis for $10-$20. In case you're curious about the math, the average dispensary pre-rolled joint has about 750 mg of cannabinoid.

Products like Marinol were originally created to get around the legal restrictions on marijuana. These products give doctors an alternative to marijuana that they may be more comfortable prescribing. Currently, natural cannabis is more accessible than it was in the past, but there are certainly still uses for Marinol. The product consists of pure THC dissolved in sesame oil, and it is given to the patient orally in pill form. THC taken orally is metabolized differently by the body, resulting in a longer, more intense high similar to that of marijuana edibles. Since Marinol contains only THC and none of the other compounds found in cannabis, the psychoactive effects are stronger than they would be otherwise. While natural cannabis is preferred by many patients today, Marinol remains the only legal marijuana-based treatment in some countries.


Dronabinol also known as (−)-trans-delta9-tetrahydrocannabinol is an active ingredient of cannabis. The drug was approved by FDA for the treatment of anorexia in patients with AIDS and chemotherapy-induced nausea and vomiting. Dronabinol exerts its action by activating CB1 and CB2 receptors which makes it a CNS active medicine.

Dronabinol

Marinol (dronabinol) is the only US FDA-approved synthetic cannabinoid. It is often marketed as a legal pharmaceutical alternative to natural cannabis.

  1. Marinol lacks several of the therapeutic compounds available in natural cannabis
  2. Marinol is more psychoactive than natural cannabis
  3. Cannabis vaporization offers advantages over orally administered THC
  4. Marinol is more expensive than natural cannabis
  5. Patients ultimately prefer natural cannabis to Marinol

Marinol (dronabinol capsules)
Side Effects:
Get emergency medical help if you have signs of an allergic reaction: hives, skin rash or burning; mouth sores; warmth, redness, or tingly feeling; difficult breathing; swelling of your face, lips, tongue, or throat.
RxList
Call your doctor at once if you have:
  • a seizure
  • fast or pounding heartbeats
  • a light-headed feeling, like you might pass out
  • confusion, trouble sleeping, problems with memory or concentration
  • unusual changes in mood or behavior
  • restlessness, feeling nervous or irritable
  • slurred speech, drowsiness
  • severe or ongoing nausea, vomiting, or stomach pain
  • increased blood pressure - severe headache, blurred vision, pounding in your neck or ears
Common side effects may include:
  • feeling "high"
  • dizziness, drowsiness, thinking problems
  • unusual thoughts or fears
  • feelings of extreme happiness
  • nausea, vomiting, stomach pain
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Liver:
Dronabinol is associated with a minimal rate of serum enzyme elevations during therapy and has not been linked to cases of clinically apparent liver injury with jaundice.

Dronabinol Hepatotoxicity:
Serum aminotransferase elevations during dronabinol therapy were reported to occur in 6% of treated patients compared to 4.3% in controls who receiving cancer chemotherapy. The aminotransferase elevations were transient, mild-to-moderate in severity, and not associated with symptoms or jaundice. There have been no convincing cases of clinically apparent liver injury attributable to dronabinol published in the literature and, thus, significant liver injury from dronabinol must be exceeding rare, if it occurs at all.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).


Marinol (dronabinol)
Maximum Dosage:
Prescribers Digital Reference
Adults:Oral capsule, antiemetic: 15 mg/m2 per dose, for 4 to 6 doses per day.
Oral solution, antiemetic: 12.6 mg/m2 per dose, for 4 to 6 doses per day.
Oral capsule, appetite stimulant: 10 mg twice daily.
Oral solution, appetite stimulant: 16.8 mg per day in divided doses.
Geriatric:Oral capsule, antiemetic: 15 mg/m2 per dose, for 4 to 6 doses per day.
Oral solution, antiemetic: 12.6 mg/m2 per dose, for 4 to 6 doses per day.
Oral capsule, appetite stimulant: 10 mg twice daily.
Oral solution, appetite stimulant: 16.8 mg per day in divided doses.
Adolescents:Safety and efficacy not established.
Children:Safety and efficacy not established.

Important Information:

Dronabinol may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have ever had depression or mental illness.

You should not use dronabinol capsules if you are allergic to sesame oil. You should not use dronabinol oral solution if you have had an allergic reaction to alcohol or if you also use disulfiram (Antabuse) or metronidazole (Flagyl).

Dronabinol can raise or lower blood pressure, especially in older adults or in people with heart problems.

Call your doctor at once if you have new or worsening mood symptoms, changes in behavior, headaches, vision problems, rapid heartbeats, or severe dizziness.

Do not use marijuana while taking dronabinol.

Avoid driving or operating machinery until you know how dronabinol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol while taking dronabinol.

Interactions:

Drug Interactions (359) Alcohol/Food Interactions (1) Disease Interactions (4)


What other drugs will affect Dronabinol?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Using dronabinol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Other drugs may affect dronabinol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 359 drugs are known to interact with Dronabinol.

Pediatric:
Appropriate studies on the relationship of age to the effects of dronabinol have not been performed in children with AIDS-related anorexia (loss of appetite). Safety and efficacy have not been established.

Appropriate studies on the relationship of age to the effects of Syndros have not been performed in children with nausea and vomiting caused by cancer medicines. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Marinol in children with nausea and vomiting caused by cancer medicines.

Because of this medicine's effects on brain function, it should be used with caution.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dronabinol in the elderly. However, elderly patients are more likely to have dementia or age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving dronabinol.

Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse or dependence, history of
  • Drug abuse or dependence, history of - Dependence on dronabinol may develop
  • Allergy to alcohol, history of - Should not be used in patients with this condition
  • Bipolar disorder (manic or depressive illness), or history of
  • Heart disease
  • Hypertension (high blood pressure)
  • Schizophrenia (mental illness), or history of
  • Seizures, history of - Use with caution. May make these conditions worse

Breastfeeding:

Summary of Use During Lactation:
Dronabinol is the synthetic form of tetrahydrocannabinol, the major active component of cannabis.

Tetrahydrocannabinol is found in the breastmilk of mothers who use cannabis products.

Because no published information is available with dronabinol use as an antiemetic during breastfeeding, an alternate antiemetic should be used.

Alternate Drugs to Consider:

  • Meclizine
  • Metoclopramide
  • Prochlorperazine
  • Thiethylperazine

WHO PDF Dronabinol

Abbvie PDF Marinol

Abbvie PDF Marinol Info

HRES PDF Marinol

What is the most important information I should know about dronabinol?
  • Dronabinol may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have ever had depression or mental illness.
  • You should not use dronabinol capsules if you are allergic to sesame oil.
  • You should not use dronabinol oral solution if you have had an allergic reaction to alcohol or if you also use disulfiram (Antabuse) or metronidazole (Flagyl).
  • Dronabinol can raise or lower blood pressure, especially in older adults or in people with heart problems.
  • Call your doctor at once if you have:
    • New or worsening mood symptoms
    • Changes in behavior
    • Headaches
    • Vision problems
    • Rapid heartbeats
    • Severe dizziness

Dronabinol:
It takes over one hour for Marinol to reach full systemic effect, compared to seconds or minutes for smoked or vaporized cannabis. Some people accustomed to inhaling just enough cannabis smoke to manage symptoms have complained of too-intense intoxication from Marinol's predetermined dosages. Many people using Marinol have said that Marinol produces a more acute psychedelic effect than cannabis, and it has been speculated that this disparity can be explained by the moderating effect of the many non-THC cannabinoids present in cannabis.

  
Dronabinol - Indications, Dosage, Side Effects and Precautions - Latest prescription information about Dronabinol. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions ...
Saturday June 24, 2017 - medindia.net

How to Take Dronabinol and Dose of Dronabinol - Find out how to take Dronabinol (drug) and its dose. Describes the best time to take the drug and precautions if any that should be followed. Caution should be exercised in patients with history ...
Monday December 15, 2014 - medindia.net

Does Dronabinol Interact with other Medications? - These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in formation. Sorry, we have no data ...
Saturday November 11, 2017 - webmd.com

Dronabinol Market : Overview, Industry Trends, Analysis Key Players, Share, Size and Report 2023 to 2028 - Jan 12, 2023 (The Expresswire) -- Final Report will add the analysis of the impact of Russia-Ukraine War and COVID-19 on this Dronabinol industry. "Dronabinol Market" areas divides into sub ...
Wednesday January 11, 2023 - marketwatch.com

Warfarin/Cannabinoids Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course ... know that you are taking dronabinol, using cannabis products such as CBD oil, or using ...
Saturday January 27, 2018 - webmd.com

RespireRx Pharmaceuticals' Australian subsidiary inks loan agreements to advance R&D for sleep apnea treatment - The goal for ResolutionRx is to progress toward commercialization of its drug dronabinol for the treatment of obstructive sleep apnea. Specifically, ResolutionRx and Radium have agreed to enter into a ...
Tuesday January 31, 2023 - proactiveinvestors.com

RespireRx sets up new Australian company to develop cannabinoid platform - The company will contribute certain dronabinol assets and certain liabilities to ResolutionRx. RespireRx added that one of the reasons for creating ResolutionRx was to allow it to participate in ...
Thursday January 12, 2023 - seekingalpha.com

RespireRx Pharmaceuticals Inc. Establishes ResolutionRx Ltd in Australia to Develop Its Pharmaceutical Cannabinoid Platform - RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a ...
Wednesday January 11, 2023 - finance.yahoo.com

RespireRx Pharmaceuticals Inc. Announces the 2nd Amendment to its License Agreement with the University of Illinois - RespireRx (OTC Markets: RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal ...
Sunday January 22, 2023 - finance.yahoo.com

Standardized Natural Product Cannabis in Pain Management and Observations at a Canadian Compassion Society: A Case Report - His prescription record, physician's notes, urine (drug) tests, plus daily interviews were maintained and examined. Daily cannabis use totaling 10 g of natural product cannabis, translating to an ...
Wednesday February 01, 2023 - medscape.com

  
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