Cesamet

DRUG DESCRIPTION

Cesamet™ (nabilone) is a synthetic cannabinoid for oral administration. Nabilone as a raw material occurs as a white to off-white polymorphic crystalline powder. In aqueous media, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0.

Chemically, nabilone is similar to the active ingredient found in naturally occurring Cannabis sativa L. [Marijuana; delta-9-tetrahydrocannabinol (delta-9-THC)]. Nabilone is (±)-trans-3-(l,l-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-l-hydroxy-6-6-dimethyl-9H-dibenzo[b,d]pyran-9-one and has the empirical formula C24H36O3. It has a molecular weight of 372.55. The structural formula is as follows:

CESAMET™ (nabilone) Structural Formula Illustration

What are the possible side effects of nabilone (Cesamet)?

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

  • hallucinations (seeing or hearing things that are not there);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

Continue using nabilone and talk with your...

Read All Potential Side Effects and See Pictures of Cesamet »

What are the precautions when taking nabilone capsules (Cesamet)?

Before taking nabilone, tell your doctor or pharmacist if you are allergic to it; or to marijuana or related products; or if you have any other allergies. This product may contain inactive ingredients, 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: liver disease, high blood pressure, heart disease, mental/mood conditions (e.g., mania, depression, schizophrenia), personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or affect your judgment. Do not drive, use machinery, or do any activity that requires alertness and clear thinking until you know how this...

Read All Potential Precautions of Cesamet »


Cesamet Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, dry mouth, feeling "high", an exaggerated sense of well-being (euphoria), lightheadedness, headache, trouble sleeping, or memory problems may occur. If any of these effects persist or worsen, tell 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. Some people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: fainting, mental/mood changes (e.g., depression, anxiety, panic, paranoia, hallucinations, psychosis), unusual weakness, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, seizures.

Because nabilone can cause mental, mood, or behavior changes, you should be under the close supervision of a responsible adult or caretaker while you are taking this medication. If you experience any such effects, remain calm and tell your doctor immediately. Do not take any more nabilone until after you consult with your doctor.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 nabilone, tell your doctor or pharmacist if you are allergic to it; or to marijuana or related products; or if you have any other allergies. This product may contain inactive ingredients, 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: liver disease, high blood pressure, heart disease, mental/mood conditions (e.g., mania, depression, schizophrenia), personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy or affect your judgment. Do not drive, use machinery, or do any activity that requires alertness and clear thinking 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 reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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

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

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

It is not known whether this drug passes into breast milk. Because other cannabinoids pass into breast milk, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Cesamet Patient Information Including Side Effects

Brand Names: Cesamet

Generic Name: nabilone (Pronunciation: NAB il own)

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

What is nabilone (Cesamet)?

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

Nabilone is used to treat severe nausea and vomiting that is caused by cancer chemotherapy. Nabilone is for use only when other medications have been unable to control the nausea and vomiting.

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

What are the possible side effects of nabilone (Cesamet)?

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

  • hallucinations (seeing or hearing things that are not there);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

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

  • dizziness, drowsiness;
  • feeling "high";
  • weakness, lack of coordination;
  • depression, anxiety, confusion;
  • dry mouth;
  • headache, trouble concentrating; 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 nabilone (Cesamet)?

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

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

Before taking nabilone, tell your doctor if you have 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 nabilone.

Nabilone 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 nabilone wear off.

There are many other medicines that can add to the side effects of nabilone. 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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