Nabilone

What is nabilone used for?

Nabilone is a prescription medicine that is used to treat upset stomach and throwing up.

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-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-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:

Each 1 mg Cesamet capsule contains 1 mg of nabilone and the following inactive ingredients: povidone and corn starch. The capsule shells contain the following inactive ingredients: FD&C Blue No. 2 (indigo carmine), red iron oxide, gelatin, and titanium dioxide.

Before taking nabilone, tell your doctor:

• If you are allergic to nabilone; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take nabilone.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take nabilone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take nabilone?

• Tell all of your health care providers that you take nabilone. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may cause mood changes when you start taking it. Be sure there is someone you can trust to help you if needed when you take nabilone.
• Some side effects may last several days after taking nabilone. Some of these effects include lowered alertness, mood changes, and confusion.
• Avoid driving and doing other tasks or actions that call for alertness while you take nabilone.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid alcohol or other drugs and natural products that slow your actions.
• Do not smoke or use other forms of cannabis (marijuana) while taking nabilone. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• You will be watched closely to make sure you do not misuse, abuse, or become addicted to nabilone.
• If you are 65 or older, use nabilone with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using nabilone while you are pregnant.

How is nabilone best taken?

Use nabilone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking nabilone as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of nabilone that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Low mood (depression).
• Mental, mood, or behavior changes that are new or worse.
• Feeling confused.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Feeling very sleepy.
• Big change in balance.
• Change in eyesight.

What are some other side effects of nabilone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Dizziness.
• Feeling sleepy.
• Feeling high (easy laughing and feeling good).
• Dry mouth.
• Feeling more or less hungry.
• Change in balance.
• Not able to sleep.
• Headache.
• Not able to focus.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out nabilone?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 0187-1231-50
  Rx Only Cesamet® CII (nabilone) capsules    1 mg
• 50 Capsules
• Each capsule
  contains 1 mg
  nabilone
• BAUSCH Health

SRC: NLM .