Dronabinol

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Generic Name: Dronabinol Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Dronabinol used for?

Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection. Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana.

How should I take Dronabinol?

Take this medication by mouth as directed by your doctor, usually up to 4 to 6 times daily if you are taking it to control nausea and vomiting or twice daily (before lunch and before dinner) if you are taking it to treat appetite loss. Follow your doctor’s instructions carefully.

The dosage is based on your medical condition and response to treatment. If you are taking this medication to control nausea and vomiting, your dosage may also be based on your body size.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as irritability, trouble sleeping, restlessness, hot flashes, diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used dronabinol for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition persists or worsens.

How do I store Dronabinol?

Dronabinol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dronabinol in the bathroom or the freezer. There may be different brands of Dronabinol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dronabinol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dronabinol?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart disease, high blood pressure, mental/mood disorders (such as mania, depression, schizophrenia), seizures.

This drug may make you dizzy or drowsy or affect your judgment. Alcohol or marijuana can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and mental/mood changes.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Dronabinol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Dronabinol. Dronabinol is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Dronabinol?

Dizziness, drowsiness, confusion, feeling “high”, an exaggerated sense of well-being, lightheadedness, nausea, vomiting, or stomach/abdominal pain may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, mental/mood changes (such as anxiety, nervousness, hallucinations, abnormal thoughts, paranoia).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dronabinol?

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Dronabinol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dronabinol?

Dronabinol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Dronabinol?

Dronabinol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Dronabinol.

What is the dose of Dronabinol for an adult?

Usual Adult Dose for Nausea/Vomiting – Chemotherapy Induced

Oral solution:

-Initial dose: 4.2 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day

-Maintenance dose: May escalate dose by 2.1 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects

-Maximum dose: 12.6 mg/m2 per dose

Oral solution comments:

-The initial dose should be rounded to the nearest 0.1 mg increment, and may need to be rounded to the nearest 0.1 mL increment (for dosing with an oral syringe).

-Patients should be given the initial dose on an empty stomach at least 30 minutes before eating; subsequent doses may be given without regard to meals.

-Healthcare providers should consider decreasing the dose to 2.1 mg orally once a day 1 to 3 hours prior to chemotherapy to decrease the risk of adverse reactions.

Oral tablets:

-Initial dose: 5 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day

-Maintenance dose: May escalate dose by 2.5 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects

-Maximum dose: 15 mg/m2 per dose

Oral tablet comments:

-Most patients respond to 5 mg given 3 or 4 times daily.

-Clinical trial data indicate escalating the dose above 7 mg/m2 increased the frequency of adverse effects with no additional antiemetic benefit.

Use: Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

Usual Adult Dose for Anorexia

Oral solution:

-Initial dose: 2.1 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.1 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 4.2 mg/day

-Maintenance dose: May increase dose to 2.1 mg/day or 4.2 mg/day orally (2.1 mg 1 hour before lunch and 4.2 mg 1 hour before dinner OR 4.2 mg 1 hour before lunch and 4.2 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired

-Maximum dose: 16.8 mg/day (8.4 mg orally 2 times a day)

Oral tablets:

-Initial dose: 2.5 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.5 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 5 mg/day

-Maintenance dose: May increase dose to 7.5 mg/day or 10 mg/day orally (2.5 mg before 1 hour before lunch and 5 mg 1 hour before dinner OR 5 mg 1 hour before lunch and 5 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired

-Maximum dose: 20 mg/day (10 mg orally 2 times a day)

Comments:

-The majority of patients in clinical trials were treated with oral tablet formulations of 5 mg/day, although the dosages ranged from 2.5 to 20 mg/day.

-If CNS symptoms (e.g., feeling high, dizziness, confusion, somnolence) occur, they usually resolve in 1 to 3 days with continued dosage.

-Early morning administration has been associated with an increased frequency of adverse reactions as compared to dosing later in the day.

Use: Appetite stimulant for anorexia associated with weight loss in AIDS patients

Dose Adjustments

Nausea/Vomiting-Chemotherapy Induced:

-Oral solution: Healthcare providers should consider initial doses of 2.1 mg/m2 orally once a day 1 to 3 hours before chemotherapy in geriatric patients to reduce the risk of CNS reactions.

Severe or Persistent CNS Symptoms (when treating anorexia in AIDS patients):

-Oral solution: 2.1 mg orally once a day 1 hour before dinner OR at bedtime

-Oral tablets: 2.5 mg orally once a day 1 hour before dinner OR at bedtime

-Doses should be given in the evening or at bedtime if symptoms continue to be a problem.

Other Comments

Administration advice:

-Caution is recommended in dose escalation due to the significant increase of disturbing psychiatric symptoms at the maximum dose.

-Coadministration with phenothiazines (e.g., prochlorperazine) may result in improved efficacy, as compared to either drug alone, without additional toxicity.

-Dose individualization is recommended to achieve maximum treatment benefit.

-Therapy should be initiated at the lowest recommended dose and titrated to clinical response.

-Patients should drink a full glass of water after taking a dose of the oral solution.

Reconstitution/preparation techniques: The manufacturer product information should be consulted for further details regarding the oral solution.

General:

-This drug demonstrates reversible, dose-related effects on appetite, mood, cognition, memory, and perception; these phenomena increase in frequency with higher dosages and are subject to great interpatient variability.

-Tachyphylaxis and tolerance develop to some of the pharmacologic effects of this drug and other cannabinoids with chronic use; however, they do not appear to develop to the appetite stimulant effect of this drug.

-The estimated lethal human dose is 30 mg/kg (IV).

-Overdosage: Gut decontamination is recommended for recent serious oral ingestion; the manufacturer product information should be consulted for overdose management.

Monitoring:

-Cardiovascular: Blood pressure and heart rate (after dose adjustments)

-Nervous System: Signs/symptoms of syncope (after dose adjustments); seizures

Patient advice:

-This drug may cause side effects such as dizziness and drowsiness that can affect your ability to perform certain activities; avoid driving and tasks such as operating machinery until you know that you can perform these activities safely during treatment.

-Do not drink alcohol while taking this drug.

What is the dose of Dronabinol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Dronabinol available?

Dronabinol is available in the following dosage forms and strengths:

  • Oral capsule,
  • Oral solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dronabinol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 16, 2018 | Last Modified: August 16, 2018

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