Dronabinol 2.5mg Capsules

Dronabinol is a synthetic cannabinoid that acts as an agonist at cannabinoid receptors (CB1 and CB2) in the central nervous system. Its antiemetic effects are thought to be mediated through the CB1 receptors in the vomiting center, while its appetite-stimulant effects are also mediated via CB1 receptors in the hypothalamus. It also has psychoactive effects.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Rapid heartbeat
Memory problems or loss
Difficulty focusing
Changes in balance
Feeling confused
Seizures
Stomach pain, upset stomach, or vomiting that is new or worsening
Mouth sores
Burning sensation
Flushing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:

Dizziness or drowsiness
Feeling euphoric (easy laughing and feeling good)

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies, including an allergy to sesame oil, this medication, or any other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
A history of alcohol or drug use disorder.
Any previous mental health or behavioral problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, such as cough or cold remedies, diet pills, mental health or mood stabilizers, and stimulants like amphetamine, should not be taken with this medication.
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed. You may need to avoid breastfeeding, and if your doctor permits it, your baby will require regular weight checks.

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Be aware that this medication can cause changes in blood pressure, which may increase the risk of falls. This risk is particularly higher in older adults and individuals with pre-existing heart conditions. Your doctor will monitor your blood pressure and heart rate; follow their instructions for checking these vital signs.

It is recommended to avoid consuming alcohol while taking this medication. Additionally, refrain from smoking or using other forms of cannabis (marijuana) during treatment. If you plan to use marijuana, other cannabis products, or prescription/over-the-counter medications that may cause drowsiness, consult your doctor first.

If you regularly consume grapefruit juice or eat grapefruits, discuss this with your doctor, as it may interact with the medication.

When initiating this medication, be prepared for potential mood changes. Ensure you have a trusted individual who can provide support if needed. Long-term use of this medication may lead to dependence, and sudden discontinuation can cause withdrawal symptoms. If you experience any adverse effects, notify your doctor promptly.

In case of accidental ingestion, seek immediate medical attention.

This medication is not approved for pediatric use. However, your doctor may prescribe it if the benefits outweigh the risks. If your child is taking this medication, consult your doctor to understand the benefits and risks.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Furthermore, if you are pregnant or become pregnant while taking this medication, it may harm the unborn baby. If you are pregnant or suspect you are pregnant, contact your doctor immediately.

• Other CNS depressants (e.g., alcohol, benzodiazepines, barbiturates, opioids, sedating antihistamines, tricyclic antidepressants): May potentiate CNS depression (drowsiness, dizziness, confusion, respiratory depression).
• CYP2C9 inhibitors (e.g., amiodarone, fluconazole, fluoxetine, gemfibrozil, sulfamethoxazole): May increase dronabinol exposure and adverse effects.
• CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ticlopidine): May increase dronabinol exposure and adverse effects.

• CYP2C9 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): May decrease dronabinol exposure and efficacy.
• CYP2C19 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease dronabinol exposure and efficacy.
• Anticholinergic agents (e.g., atropine, scopolamine): May potentiate tachycardia.

• Not available

• Dizziness
• Somnolence
• Euphoria
• Paranoia
• Confusion
• Disorientation
• Hallucinations
• Abdominal pain
• Nausea
• Vomiting
• Orthostatic hypotension
• Tachycardia
• Mood changes
• Anxiety
• Irritability

Dronabinol is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are reports of neonatal withdrawal syndrome in infants exposed to cannabis in utero.

Dronabinol and its active metabolites are excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., developmental effects, sedation, poor feeding), breastfeeding is not recommended during dronabinol therapy.

Safety and effectiveness have not been established in pediatric patients. Use in children for CINV is generally reserved for refractory cases and requires careful consideration of risks vs. benefits, especially due to potential for psychoactive effects and neurodevelopmental concerns. Dosing is typically weight/surface area based if used.

Use with caution in elderly patients, as they may be more sensitive to the psychoactive and cardiovascular effects (e.g., dizziness, orthostatic hypotension, confusion). Start with lower doses and titrate slowly. Monitor closely for adverse effects.

• Dronabinol is a Schedule III controlled substance, indicating a moderate to low potential for physical and psychological dependence.
• It is often reserved for patients who have not responded to conventional antiemetic therapies.
• The psychoactive effects (e.g., euphoria, dizziness, paranoia) are dose-dependent and can be significant, especially at higher doses or in opioid-naive patients.
• Administer the first dose in a supervised setting to assess patient tolerance to psychoactive effects.
• For CINV, it's crucial to administer dronabinol 1-3 hours *before* chemotherapy to allow for onset of action.
• For appetite stimulation, taking it before lunch and dinner can maximize its effect on food intake.
• Patients should be advised to avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms (e.g., irritability, insomnia, restlessness).

• Nabilone (another synthetic cannabinoid, Schedule II)
• Ondansetron (5-HT3 receptor antagonist for CINV)
• Granisetron (5-HT3 receptor antagonist for CINV)
• Palonosetron (5-HT3 receptor antagonist for CINV)
• Netupitant/palonosetron (NK1/5-HT3 receptor antagonist combination for CINV)
• Aprepitant (NK1 receptor antagonist for CINV)
• Olanzapine (atypical antipsychotic with antiemetic properties)
• Megestrol acetate (for appetite stimulation in AIDS-related anorexia)
• Mirtazapine (antidepressant with appetite stimulant properties)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it happened, as this will help healthcare professionals provide the best possible care.