Dronabinol 5mg Capsules

Dronabinol is a synthetic cannabinoid with complex effects on the central nervous system (CNS), including central sympathomimetic activity. It is believed to exert its antiemetic effects through activation of cannabinoid receptors (CB1) in the CNS, particularly in areas involved in emesis (e.g., chemoreceptor trigger zone). Its appetite-stimulant effects are also thought to be mediated via CB1 receptor activation, leading to increased food intake.

Serious Side Effects: Seek Medical Attention 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 help 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, especially to sesame oil, this medication, or any of its components. Describe your allergic reactions and symptoms.
A history of alcohol or drug use disorder.
Previous mental health or behavioral issues.
Current medications, 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 drug.
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed. You may need to avoid breastfeeding, but if your doctor permits it, your baby will require regular weight checks.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Always check with your doctor before starting, stopping, or changing the dose of any medication to avoid potential interactions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be cautious when climbing stairs, as changes in blood pressure may increase your risk of falling. This risk is particularly higher in older adults and individuals with heart problems. Consult your doctor to discuss any concerns.

Regularly monitor your blood pressure and heart rate as instructed by your doctor. Avoid consuming alcohol while taking this medication. Refrain from smoking or using other forms of cannabis (marijuana) during treatment, and discuss any concerns with your doctor.

Before using marijuana, other cannabis products, or prescription/over-the-counter medications that may cause drowsiness, consult your doctor. If you frequently consume grapefruit juice or eat grapefruit, inform your doctor, as this may interact with your medication.

Be aware that this medication may cause mood changes, especially when you first start taking it. Ensure you have a trusted individual who can provide support if needed. Long-term use of this drug may lead to dependence, and suddenly stopping treatment may result in 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 use in children; however, your doctor may determine that the benefits outweigh the risks. If your child has been prescribed this medication, consult your doctor to understand the benefits and risks.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, this medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are pregnant while taking this medication, contact your doctor immediately.

• CNS depressants (e.g., barbiturates, benzodiazepines, opioids, sedating antihistamines, alcohol): Increased CNS depression.
• CYP2C9 inhibitors (e.g., amiodarone, fluconazole, fluoxetine, gemfibrozil, sulfamethoxazole): May increase dronabinol exposure.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase dronabinol exposure.
• CYP2C9 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease dronabinol exposure.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease dronabinol exposure.

• Anticholinergics (e.g., atropine, scopolamine): Potential for additive tachycardia.
• Sympathomimetics (e.g., amphetamines, cocaine): Potential for additive cardiovascular effects (tachycardia, hypertension).
• Disulfiram/Metronidazole: (Note: This interaction is primarily relevant for dronabinol oral solution due to ethanol content, not capsules).

• Dizziness
• Drowsiness
• Confusion
• Euphoria
• Paranoia
• Hallucinations
• Tachycardia
• Orthostatic hypotension
• Abdominal pain
• Nausea
• Vomiting

Category C. Dronabinol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects on fetal development.

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

Safety and efficacy have not been established in pediatric patients (<18 years of age). Use is generally not recommended.

Use with caution in elderly patients, generally starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more sensitive to the psychoactive effects of dronabinol.

• Dronabinol has a delayed onset of action compared to other antiemetics, making it less suitable for 'as needed' acute nausea. It is best used prophylactically for CINV.
• Due to its psychoactive effects, dronabinol has a potential for abuse and dependence. Prescribe with caution, especially in patients with a history of substance abuse.
• Patients should be advised about the potential for CNS effects (e.g., dizziness, confusion, euphoria, paranoia) and advised to avoid activities requiring mental alertness.
• Orthostatic hypotension can occur; advise patients to rise slowly from a sitting or lying position.
• The 11-hydroxy-THC metabolite is also psychoactive and contributes to the overall effect and duration of action.
• Capsules should be stored in a refrigerator (2-8°C or 36-46°F) and protected from light. Some formulations may allow for room temperature storage for a limited time; check specific product labeling.

• For Chemotherapy-Induced Nausea and Vomiting (CINV): 5-HT3 receptor antagonists (e.g., ondansetron, granisetron), NK1 receptor antagonists (e.g., aprepitant, fosaprepitant), corticosteroids (e.g., dexamethasone), dopamine receptor antagonists (e.g., prochlorperazine, metoclopramide), olanzapine.
• For Anorexia/Weight Loss in AIDS: Megestrol acetate, ghrelin mimetics (e.g., anamorelin - not FDA approved for AIDS wasting), other appetite stimulants.

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 discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.