Dronabinol

WHY is this medicine prescribed?

Dronabinol is used to treat nausea and vomiting caused by chemotherapy in people who have already taken other medications to treat this type of nausea and vomiting without good results. Dronabinol is also used to treat loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS). Dronabinol is in a class of medications called cannabinoids. It works by affecting the area of the brain that controls nausea, vomiting, and appetite.

HOW should this medicine be used?

Dronabinol comes as a capsule and as a solution (liquid) to take by mouth. When dronabinol capsules and solution are used to treat nausea and vomiting caused by chemotherapy, it is usually taken 1 to 3 hours before chemotherapy and then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses a day. The first dose of the solution is usually taken on an empty stomach at least 30 minutes before eating, but the following doses can be taken with or without food. When dronabinol capsules and solution are used to increase appetite, they are usually taken twice a day, about an hour before lunch and supper Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dronabinol exactly as directed.

Swallow the capsules whole; do not chew or crush them.

Swallow the dronabinol solution with a full glass of water (6 to 8 ounces).

Always use the oral dosing syringe that comes with dronabinol solution to measure your dose. Talk to your doctor or pharmacist if you have questions about how to measure your dose of dronabinol solution.

Your doctor will probably start you on a low dose of dronabinol and may gradually increase your dose. Your doctor may also decrease your dose if you experience side effects that do not go away after 1 to 3 days. Be sure to tell your doctor how you are feeling during your treatment with dronabinol.

Dronabinol may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication.

Dronabinol will control your symptoms only as long as you take the medication. Continue to take dronabinol even if you feel well. Do not stop taking dronabinol without talking to your doctor. If you suddenly stop taking dronabinol, you may experience withdrawal symptoms such as irritability, difficulty falling asleep or staying asleep, restlessness, hot flashes, sweating, runny nose, diarrhea, hiccups, and loss of appetite.

Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking dronabinol,

• tell your doctor and pharmacist if you are allergic (lip swelling, hives, rash, oral lesions, skin burning, flushing, throat tightness) to dronabinol, other cannabinoids such as nabilone (Cesamet) or marijuana (cannabis), any other medications, any of the ingredients in dronabinol capsules including sesame oil, or any of the ingredients in dronabinol solution such as alcohol. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking disulfiram (Antabuse) or metronidazole (Flagyl, in Pylera) or if have stopped taking these medications within the past 14 days. Your doctor will probably tell you not to take dronabinol solution if you are taking one or more of these medications. If you stop taking dronabinol solution, you should wait 7 days before you start to take disulfiram (Antabuse) or metronidazole (Flagyl, in Pylera).

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Nexterone, Pacerone); amphetamines such as amphetamine (Adzenys, Dyanavel XR, in Adderall), dextroamphetamine (Dexedrine, in Adderall), and methamphetamine (Desoxyn); amphotericin B (Ambisome); antibiotics such as clarithromycin (Biaxin, in Prevpac) and erythromycin (E.E.S., Eryc, Ery-tab, others); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole; anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants including amitriptyline, amoxapine, and desipramine (Norpramin); antihistamines; atropine (Atropen, in Duodote, in Lomotil, others); barbiturates including phenobarbital and secobarbital (Seconal); buspirone ; cyclosporine (Gengraf, Neoral, Sandimmune); diazepam (Diastat, Valium); digoxin (Lanoxin); fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax); ipratropium (Atrovent); lithium (Lithobid); medications for anxiety, asthma, colds, irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; muscle relaxants; naltrexone (Revia, Vivitrol, in Contrave); narcotic medications for pain such as opioids; prochlorperazine (Compro, Procomp); propranolol (Hemangeol, Inderal, Innopran); ritonavir (Kaletra, Norvir, in Technivie); scopolamine (Transderm-Scop); sedatives; sleeping pills; tranquilizers; and theophylline (Elixophyllin, Theochron, Uniphyl). Before taking dronabinol capsules, tell your doctor if you are taking disulfiram (Antabuse). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with dronabinol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you use or have ever used marijuana or other street drugs and if you drink or have ever drunk large amounts of alcohol. Also tell your doctor if you have or have ever had heart disease, high blood pressure, seizures, dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality), or a mental illness such as mania (frenzied or abnormally excited mood), depression (feelings of hopelessness, loss of energy and/or loss of interest in doing previously enjoyable activities), or schizophrenia (a mental illness that causes disturbed or unusual thinking and strong or inappropriate emotions),

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking dronabinol, call your doctor immediately.

• do not breastfeed while you are taking dronabinol capsules or solution. If you are taking dronabinol solution for nausea and vomiting caused by chemotherapy, do not breastfeed during your treatment and for 9 days after your final dronabinol dose.

• you should know that dronabinol may make you drowsy and may cause changes in your mood, thinking, memory, judgment, or behavior, especially at the beginning of your treatment. You will need to be supervised by a responsible adult when you first begin taking dronabinol and whenever your dose is increased. Do not drive a car, operate machinery or do any other activity that requires mental alertness until you know how this medication affects you.

• do not drink alcoholic beverages while you are taking dronabinol. Alcohol can make the side effects from dronabinol worse.

• you should know that dronabinol may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This may be more common when you first start taking dronabinol. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor or nutritionist and read the manufacturer's information for the patient to find out about ways to encourage yourself to eat when your appetite is poor and about which types of foods are the best choices for you.

Do not eat grapefruit or drink grapefruit juice while taking dronabinol oral solution.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dronabinol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• stomach pain
• nausea
• vomiting
• memory loss
• anxiety
• confusion
• sleepiness
• difficulty concentrating
• dizziness
• unsteady walking
• feeling like you are outside of your body
• ''high'' or elevated mood
• hallucinations (seeing things or hearing voices that do not exist)
• depression
• strange or unusual thoughts
• headaches
• vision problems
• feeling lightheaded

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• seizures
• fast or pounding heartbeat
• fainting

Dronabinol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store capsules in a cool place (between 46-59 °F, 8-15 °C) or in the refrigerator. Do not allow the capsules to freeze. Store the unopened dronabinol solution in the container in the refrigerator. Once opened, the dronabinol solution can be stored at room temperature for up to 28 days. Keep medication away from heat, direct light, and moisture.

Store dronabinol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many capsules and solution are remaining so you will know if any medication is missing.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• inappropriate happiness
• sharper senses than usual
• changed awareness of time
• red eyes
• dry mouth
• fast heartbeat
• memory problems
• feeling that you are outside of your body
• mood changes
• difficulty urinating
• constipation
• decreased coordination
• extreme tiredness
• difficulty speaking clearly
• dizziness or fainting when standing up too fast

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Do not let anyone else take your medication. Your dronabinol (Marinol^®) prescription may be refilled only a limited number of times.

If you are taking dronabinol (Syndros^®), it is not refillable. Be sure to schedule appointments with your doctor so that you do not run out of dronabinol (Syndros^®) if you are to take this medication on a regular basis.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.