Marinol

DRUG DESCRIPTION

Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas:

MARINOL (dronabinol) structural formula illustration

Dronabinol, the active ingredient in MARINOL® (dronabinol) Capsules, is synthetic delta-9- tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol is also a naturally occurring component of Cannabis sativa L. (Marijuana).

Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

Capsules for oral administration: MARINOL (dronabinol) Capsules is supplied as round, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL (dronabinol) Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.

What are the possible side effects of dronabinol (Marinol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less...

Read All Potential Side Effects and See Pictures of Marinol »

What are the precautions when taking dronabinol (Marinol)?

Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood conditions (e.g., mania, depression, schizophrenia), seizure disorder.

This drug may make you dizzy or drowsy or affect your judgment. Do not engage in activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects...

Read All Potential Precautions of Marinol »


Marinol Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, confusion, feeling "high", an exaggerated sense of well-being, lightheadedness, headache, red eyes, dry mouth, nausea, vomiting, stomach pain, clumsiness, or unsteadiness may occur, especially during the first several days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weakness, flushing of the face, fast/pounding heartbeat, mental/mood changes (e.g., difficulty concentrating, memory loss, hallucinations, abnormal thoughts, paranoia, depression, nervousness), slurred speech, ringing in the ears, vision changes, fainting.

It is important that you take this medication under the supervision of a responsible adult because mental, mood, or behavior changes may occur. If you experience any such effects, remain calm and try not to panic. Tell your doctor immediately. Do not take any more dronabinol until after you consult with your doctor.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood conditions (e.g., mania, depression, schizophrenia), seizure disorder.

This drug may make you dizzy or drowsy or affect your judgment. Do not engage in activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects you and until you are sure you can perform such activities safely. Alcohol can worsen these side effects. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially drowsiness and mental/mood changes.

This medication is not recommended for use during pregnancy because of possible unborn baby/infant harm reported with marijuana exposure (dronabinol contains the active substance found in marijuana). Consult your doctor for more details.

This drug passes into breast milk. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Marinol Patient Information Including Side Effects

Brand Names: Marinol

Generic Name: dronabinol (Pronunciation: droe NAH bih nol)

  • What is dronabinol (Marinol)?
  • What are the possible side effects of dronabinol (Marinol)?
  • What is the most important information I should know about dronabinol (Marinol)?
  • What should I discuss with my health care provider before taking dronabinol (Marinol)?
  • How should I take dronabinol (Marinol)?
  • What happens if I miss a dose (Marinol)?
  • What happens if I overdose (Marinol)?
  • What should I avoid while taking dronabinol (Marinol)?
  • What other drugs will affect dronabinol (Marinol)?
  • Where can I get more information?

What is dronabinol (Marinol)?

Dronabinol is a man-made form of cannabis (marijuana is an herbal form of cannabis). Dronabinol causes many effects on your central nervous system.

Dronabinol is used to treat loss of appetite in people with AIDS. It is also used to treat severe nausea and vomiting that is caused by cancer chemotherapy. Dronabinol is for use only when other medications have been unable to control the nausea and vomiting.

Dronabinol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dronabinol (Marinol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less serious side effects:

  • mood changes;
  • dizziness, trouble concentrating;
  • feeling "high";
  • weakness, lack of coordination;
  • anxiety, confusion;
  • stomach pain, nausea, vomiting, diarrhea;
  • warmth or tingly feeling; or
  • sleep problems (insomnia).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dronabinol (Marinol)?

Dronabinol may be habit-forming and should be used only by the person it was prescribed for. Dronabinol should never be given to another person, especially someone who has a history of drug addiction or habitual marijuana use. Keep the medication in a secure place where others cannot get to it.

Do not use dronabinol if you have ever had an allergic reaction to natural or man-made marijuana.

Before taking dronabinol, tell your doctor if you have a seizure disorder, high blood pressure, heart disease, a history of mental illness or drug addiction, or if you are also using other medicines that can affect your central nervous system, such as a tranquilizer, sleep medicine, or anti-psychotic medications.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Avoid using other medicines that affect the central nervous system (such as stimulants, diet pills, cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression, anxiety, mental illness, or Parkinson's disease). These other drugs can add to the effects of dronabinol.

Dronabinol causes effects that will impair your thinking or reactions. Do not drive or do anything that requires you to be awake and alert until the effects of dronabinol wear off.

There are many other medicines that can add to the side effects of dronabinol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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