Cesamet is a man-made form of cannabis (also known as marijuana).

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

Cesamet may also be used for purposes not listed in this medication guide.

Cesamet may be habit-forming and should be used only by the person it was prescribed for. Cesamet 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 Cesamet, 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.

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 Cesamet.

Cesamet 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 Cesamet wear off.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Cesamet if you have ever had an allergic reaction to natural or man-made marijuana such as dronabinol (Marinol).

To make sure Cesamet is safe for you, tell your doctor if you have:

• high blood pressure;

• heart disease;

• liver or kidney disease;

• history of alcoholism or drug addiction; or

• past or present mental illness (depression, schizophrenia, bipolar disorder, psychosis).

Cesamet may be habit-forming. Never share Cesamet with another person, especially someone with a history of drug abuse or addiction or habitual marijuana use. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Cesamet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nabilone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Older adults may be more sensitive to the effects of this medication.

Do not give this medication to anyone under 18 years old.

Take Cesamet exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cesamet is usually given 1 to 3 hours before you receive your chemotherapy treatment. Your doctor may recommend that you take a small dose on the night before your chemotherapy.

Nabilone may also be used 2 or 3 times each day of the chemotherapy treatment cycle, and for 48 hours after treatment ends, if needed.

The effects of Cesamet may last for 48 to 72 hours, and this length of time may not be the same every time you take the medication.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Cesamet is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Initial dosage: 1 mg or 2 mg orally twice daily 1 to 3 hours before the chemotherapeutic agent is administered. A dose of 1 mg to 2 mg by mouth the night before chemotherapy may be useful.

Cesamet may be administered two to three times daily during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy.

The maximum recommended daily dose is 6 mg given in divided doses three times daily.

Usual Pediatric Dose of Cesamet for Nausea/Vomiting -- Chemotherapy Induced:

Safety and effectiveness have not been established in patients younger than 18 years of age. Caution is recommended in prescribing Cesamet to children because of psychoactive effects.

You should not use Cesamet if you have ever had an allergic reaction to natural or man-made marijuana such as dronabinol (Marinol).

To make sure Cesamet is safe for you, tell your doctor if you have:

• high blood pressure;

• heart disease;

• liver or kidney disease;

• history of alcoholism or drug addiction; or

• past or present mental illness (depression, schizophrenia, bipolar disorder, psychosis).

Cesamet may be habit-forming. Never share Cesamet with another person, especially someone with a history of drug abuse or addiction or habitual marijuana use. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Cesamet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nabilone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Older adults may be more sensitive to the effects of this medication.

Do not give this medication to anyone under 18 years old.

Call your doctor for instructions if you forget to take this medicine at the correct time before your chemotherapy treatment.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Stop using Cesamet and call your doctor at once if you have:

• hallucinations (seeing or hearing things that are not real);

• confusion, unusual thoughts or behavior;

• anxiety, panic, paranoia, extreme fear;

• fast heart rate; or

• a light-headed feeling, like you might pass out.

Common Cesamet side effects may include:

• headache, dizziness, drowsiness;

• feeling "high";

• weakness, lack of coordination;

• depressed mood;

• dry mouth; or

• trouble concentrating.

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.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Cesamet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with nabilone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.