Syndros 5 mg/mL oral solution

Generic name:
Dronabinol solution - oral

Pronunciation
(droe-NAB-i-nol)

Brand name(s)
Syndros

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

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking dronabinol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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 (1 hour before lunch and 1 hour before dinner) if you are taking it to treat loss of appetite. Drink a full glass of water (8 ounces/240 milliliters) right after taking each dose. Follow your doctor's instructions carefully.

Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

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 does not get better or if it gets worse.

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 last or get worse, 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 this medication has been prescribed because your doctor 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

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana (cannabis); or if you have any other allergies. This product may contain inactive ingredients (such as alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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 may affect your judgment. Alcohol or marijuana (cannabis) 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 (cannabis).

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.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dronabinol. Dronabinol may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may harm a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Dronabinol solution contains alcohol. Certain medications (such as disulfiram, metronidazole) should not be taken within 2 weeks before, during, or 7 days after taking dronabinol solution. Doing so can lead to a reaction that may include flushing, throbbing headache, breathing problems (such as shortness of breath, fast breathing), nausea, vomiting, dizziness, extreme tiredness, fainting, fast/irregular heartbeat, or blurred vision. Consult your doctor or pharmacist for details.

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 (cannabis), 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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness/dizziness, fast heartbeat, mental/mood changes, seizures.

Do not share this medication with others. Sharing it is against the law.

Keep this medication in a safe place to prevent theft, misuse, or abuse.

Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store the unopened bottle in the refrigerator. Store the opened bottle in the refrigerator or at room temperature. Once the bottle is opened, this medication expires after 42 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.