Dronabinol

What is Dronabinol?

• Dronabinol (Marinol; Syndros) is a cannabinoid used to treat nausea and vomiting and to stimulate appetite, particularly in patients with acquired immunodeficiency syndrome (AIDS).

Dronabinol

Dronabinol2D

Dronabinol3Dan

What are the uses of this medicine?

Dronabinol (Marinol; Syndros) capsules are a prescription medicine used in adults to treat:

• loss of appetite (anorexia) in people with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
• nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.

• Dronabinol capsules are a controlled substance (CIII) because it contains dronabinol, which can be a target for people who abuse prescription medicines or street drugs.
• Keep your dronabinol capsules in a safe place to protect it from theft. Never give your dronabinol capsules to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

How does this medicine work?

• Dronabinol (droe nab’ i nol) is the main isomer of tetrahydrocannabinol, the principal psychoactive constituent of the marijuana plant (Cannabis sativa).
• Dronabinol is a partial agonist of the cannabinoid receptors which are found in the central nervous system (CB1 receptor), but also peripherally (largely CB2 receptors).
• Activation of CB receptors results in effects on appetite, mood, cognition, memory and perception.
• Dronabinol therapy has been shown to improve in patients with AIDS related weight loss and to decrease the nausea and vomiting associated with cancer chemotherapy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
• had an allergic reaction to sesame oil.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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
• theophylline (Elixophyllin, Theochron, Uniphyl)

• 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.
• If you stop taking dronabinol solution, you should wait 7 days before you start to take disulfiram (Antabuse) or metronidazole (Flagyl, in Pylera).

Is this medicine FDA approved?

• Dronabinol was approved for use in the United States in 1985 and current indications include treatment of anorexia associated with weight loss in patients with AIDS, and prevention of cancer chemotherapy associated nausea and vomiting.

How should this medicine be used?

Recommended dosage: In Anorexia Associated with Weight Loss in Adult Patients with AIDS:

• The recommended adult starting dosage is 2.5 mg orally twice daily, one hour before lunch and dinner.
• In elderly patients or patients unable to tolerate 2.5 mg twice daily, consider initiating dronabinol capsules at 2.5 mg once daily one hour before dinner or at bedtime to reduce the risk of central nervous system (CNS) symptoms.
• If tolerated and further therapeutic effect is desired, the dosage may be increased gradually to 2.5 mg one hour before lunch and 5 mg one hour before dinner. Increase the dose of dronabinol capsules gradually in order to reduce the frequency of dose-related adverse reactions.
• Maximum Dosage: 10 mg twice daily.

In Nausea and Vomiting Associated with Chemotherapy in Adult Patients Who Failed Conventional Antiemetics:

• The recommended starting dosage is 5 mg/m2, administered 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses per day.
• In elderly patients, consider initiating dronabinol capsules at 2.5 mg/m2 once daily 1 to 3 hours prior to chemotherapy to reduce the risk of CNS symptoms
• The dosage can be titrated to clinical response during a chemotherapy cycle or subsequent cycles, based upon initial response, as tolerated to achieve a clinical effect, in increments of 2.5 mg/m2.
• The maximum dosage is 15 mg/m2 per dose for 4 to 6 doses per day.

Administration:

• Dronabinol comes as a capsule and as a solution (liquid) to take by mouth.
• Take dronabinol capsules exactly as your doctor tells you to.
• Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.

If you are an adult with AIDS with loss of appetite and weight loss:

• Dronabinol capsules are usually taken 2 times each day, 1 hour before lunch and 1 hour before dinner.
• If you are elderly or unable to tolerate this dose of dronabinol capsules, your doctor may prescribe dronabinol capsules to be taken 1 time each day, 1 hour before dinner or bedtime to reduce your chance of having nervous system problems.

If you are an adult with nausea and vomiting caused by anti-cancer medicine:

• Dronabinol capsules are usually taken 1 to 3 hours before your chemotherapy treatment and then every 2 to 4 hours after chemotherapy for up to 4 to 6 doses each day.
• If you are elderly, your doctor may prescribe Dronabinol capsules to be taken 1 to 3 hours before your chemotherapy, 1 time each day to reduce your chance of having nervous system problems.
• Take your first dose of dronabinol capsules on an empty stomach at least 30 minutes before eating.
• After your first dose of dronabinol capsules, you can take dronabinol capsules with or without food.
• Always take your dose at the same time with regard to meals.

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 2.5 mg, 5 mg, 10 mg
• as a solution (liquid)

This medicine is available in fallowing brand namesː

• Marinol
• Syndros

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• feeling extremely happy (euphoria)
• overly suspicious or feeling people want to harm you (paranoid reaction)
• sleepiness
• abnormal thoughts
• stomach-area (abdominal) pain
• nausea
• vomiting

Dronabinol capsules can cause serious side effects, including:

• Worsening mental (psychiatric) symptoms
• Problems thinking clearly
• Changes in your blood pressure
• Seizures
• Drug and alcohol abuse
• Nausea,vomiting, or stomach-area (abdominal) pain

What special precautions should I follow?

• Do not drive, operate machinery, or do other dangerous activities until you know how dronabinol capsules affect you. Dronabinol capsules taken with other medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.
• Dronabinol may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with a psychiatric history. Monitor for symptoms and avoid concomitant use of drugs with similar effects. Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol capsules does not affect them adversely.
• Patients may experience occasional hypotension, possible hypertension, syncope, or tachycardia while taking dronabinol capsules. Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes after initiating or increasing the dosage of dronabinol capsules.
• Seizure and seizure-like activity have been reported in patients receiving dronabinol. Weigh the potential risk versus benefits before prescribing dronabinol capsules to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold. Monitor patients and discontinue if seizures occur.
• Patients with a history of substance abuse or dependence, including marijuana or alcohol, may be more likely to abuse dronabinol capsules as well. Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing dronabinol capsules and monitor for the development of associated behaviors or conditions.
• Nausea, vomiting, or abdominal pain can occur during treatment with synthetic delta-9­ tetrahydrocannabinol (delta-9-THC), the active ingredient in dronabinol capsules. Consider dose reduction or discontinuation, if worsening of symptoms while on treatment.
• Advise patients, especially elderly patients, that cognitive impairment or an altered mental state may also occur during treatment with dronabinol capsules and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment.
• Advise HIV infected women with anorexia associated with weight loss, not to breastfeed.
• Advise women with nausea and vomiting associated with cancer chemotherapy not to breastfeed during treatment with dronabinol capsules and for 9 days after the last dose
• Dronabinol is associated with a minimal rate of serum enzyme elevations during therapy and has not been linked to cases of clinically apparent liver injury with jaundice.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension.

• Patients may also experience panic reactions if they have a prior history of nervousness or anxiety, and seizures may occur in patients with existing seizure disorders.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• It is not known if dronabinol can be removed by dialysis in cases of overdose.

Can this medicine be used in pregnancy?

• Dronabinol capsules, a synthetic cannabinoid, may cause fetal harm.
• Avoid use of dronabinol capsules in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of dronabinol capsules have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dronabinol
• Inactive ingredients:Capsules for oral administration are supplied as oval, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each capsule strength is formulated with the following inactive ingredients: 2.5 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide, and FD&C Red No. 40; 5 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide, FD&C Yellow No. 6, FD&C Red No. 40 and FD&C Blue No. 1; and 10 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide and FD&C Yellow No. 6.

Who manufactures and distributes this medicine?

Manufactured for:

• Lannett Company, Inc.
• Philadelphia, PA

Manufactured by:

• SWISS CAPS AG
• Husenstrasse
• Kirchberg
• Switzerland

What should I know about storage and disposal of this medication?

• Store dronabinol capsules in a cool place such as in a refrigerator, at a temperature between 36°F to 46°F (2°C to 8°C).
• Do not freeze dronabinol capsules.
• Keep the dronabinol capsules container closed tightly.

• Dailymed label info on Dronabinol
• FDA Dronabinol