Dronabinol 10mg Capsules

Dronabinol is a synthetic delta-9-tetrahydrocannabinol (THC), the primary psychoactive component of Cannabis sativa. It is an agonist at cannabinoid receptors (CB1 and CB2) in the central nervous system and peripheral tissues. Its antiemetic effects are thought to be mediated through inhibition of the vomiting center in the medulla oblongata. Its appetite-stimulant effects are believed to be mediated through effects on the hypothalamus.

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 discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness
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, as some may interact with this medication. Specifically, avoid taking certain cough or cold remedies, diet pills, medications for mental or mood problems, or stimulants like amphetamine, as they may interact with this drug.
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy.
Breastfeeding or plans to breastfeed, as you may need to avoid breastfeeding. If your doctor advises that you can breastfeed, 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 dose of any medication without consulting your doctor.

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 driving or engaging in activities that require alertness, as it may affect your ability to perform these tasks safely. 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.

Avoid consuming alcohol while taking this medication, as it may interact with the drug. Additionally, refrain from smoking or using other forms of cannabis (marijuana) during treatment, and consult your doctor before doing so. If you plan to use marijuana, other cannabis products, or prescription/over-the-counter medications that may cause drowsiness, discuss this with your doctor beforehand.

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

When initiating treatment with this medication, be aware that it may cause mood changes. Ensure you have a trusted individual who can provide support if needed. Long-term use of this medication can lead to dependence, and sudden cessation 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 prescribe it if the benefits outweigh the risks. If your child is taking this medication, consult your doctor about the potential 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, inform your doctor immediately, as it may harm the unborn baby.

• CNS depressants (e.g., barbiturates, benzodiazepines, opioids, sedating antihistamines, alcohol): Increased risk of CNS depression (drowsiness, dizziness, confusion, respiratory depression).
• CYP2C9 inhibitors (e.g., amiodarone, fluconazole, fluoxetine, gemfibrozil, sulfamethoxazole): May increase dronabinol exposure and risk of adverse effects.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May increase dronabinol exposure and risk of adverse effects.
• CYP2C9 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease dronabinol exposure and efficacy.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease dronabinol exposure and efficacy.

• Anticholinergics (e.g., atropine, scopolamine): Potential for additive tachycardia.
• Sympathomimetics (e.g., pseudoephedrine, amphetamines): Potential for additive tachycardia and hypertension.
• Disulfiram, Metronidazole (with alcohol-containing liquid formulations of dronabinol, not applicable to capsules): Potential for disulfiram-like reaction.

• Dizziness
• Drowsiness
• Confusion
• Mood changes (euphoria, depression, anxiety)
• Hallucinations
• Paranoia
• Orthostatic hypotension
• Tachycardia
• Abdominal pain
• Nausea
• Vomiting

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Dronabinol has shown adverse effects in animal studies. There is a potential for neonatal cannabinoid withdrawal syndrome if used during pregnancy.

Not recommended. THC (dronabinol) and its metabolites are excreted into breast milk and can accumulate in the infant. Potential for adverse effects on the infant's development, including neurodevelopmental effects, and potential for sedation.

Safety and efficacy have not been established in pediatric patients (<18 years of age) for either CINV or AIDS-related anorexia. Use is generally not recommended.

Use with caution in elderly patients. They may be more sensitive to the CNS and cardiovascular effects (e.g., dizziness, orthostatic hypotension, confusion) of dronabinol. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

• Dronabinol is a Schedule III controlled substance, indicating a moderate to low potential for physical and psychological dependence.
• Patients should be warned about the potential for psychoactive effects (e.g., euphoria, dizziness, confusion, hallucinations) and advised to avoid activities requiring mental alertness.
• Dose titration is crucial to minimize adverse effects and achieve optimal therapeutic response. Start low and go slow.
• Capsules must be stored in the refrigerator (2-8°C or 36-46°F) to maintain stability. Do not freeze.
• Monitor for signs of cannabinoid hyperemesis syndrome in patients with chronic, high-dose use, although rare with therapeutic doses.
• Consider the patient's psychiatric history, as dronabinol can exacerbate mood disorders or psychosis.

• 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).
• For AIDS-related Anorexia with Weight Loss: Megestrol acetate, mirtazapine, ghrelin mimetics (e.g., anamorelin - not FDA approved for AIDS-related anorexia).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for more information. 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 details about the medication taken, the amount, and the time it happened.