Syndros

What is Syndros used for?

Syndros is a medication that is used to help you eat more. It is used to treat upset stomach and throwing up.

Description

Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas:

C21H30O2 (molecular weight=314.46)

Dronabinol is a clear colorless to amber oil. Dronabinol is insoluble in water. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

SYNDROS (dronabinol) oral solution, 5 mg/mL is a clear, pale yellow to brown solution. Each mL of SYNDROS contains 5 mg of dronabinol as an active ingredient and the following inactive ingredients: 50 % (w/w) dehydrated alcohol, polyethylene glycol 400, propylene glycol, sucralose, methyl paraben, propyl paraben, butylated hydroxyanisole, and water.

 Mechanism of Action

Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.

Before taking Syndros, tell your doctor:

For all patients taking this medicine (Syndros):

• If you are allergic to this medicine (Syndros); any part of this medicine (Syndros); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine (Syndros) like certain cough or cold remedies, diet pills, drugs for mental or mood problems, or stimulants like amphetamine. There are many drugs that must not be taken with this medicine (Syndros).
• If you have a feeding tube. This medicine is not for use with some types of feeding tubes.
• If you are pregnant or may be pregnant. Do not take this medicine (Syndros) if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take this medicine (Syndros). You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

Children:

• If your child is a premature newborn. This medicine is not for use in certain ages of premature newborns.

This is not a list of all drugs or health problems that interact with this medicine (Syndros).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Syndros) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Syndros?

• Tell all of your health care providers that you take this medicine (Syndros). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (Syndros) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• High or low blood pressure can happen after this medicine (Syndros) is started or after the dose is raised. Changes in blood pressure may raise the chance of falling. Older people and people with heart problems may have a higher chance of changes in blood pressure and falling. Talk with the doctor.
• Check blood pressure and heart rate as the doctor has told you.
• Avoid drinking alcohol while taking this medicine (Syndros).
• Do not smoke or use other forms of cannabis (marijuana) while taking this medicine (Syndros). Talk with your doctor.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may cause mood changes when you start taking it. Be sure there is someone you can trust to help you if needed when you take this medicine (Syndros).
• This medicine may be habit-forming with long-term use.
• Tell your doctor if you have ever had drug abuse, alcohol abuse, or mental or mood problems.
• If you stop taking this medicine (Syndros) all of a sudden, you may have signs of withdrawal. Tell your doctor if you have any bad effects.
• If this medicine (Syndros) is taken by accident, get medical help right away.
• Do not take disulfiram or metronidazole within 7 days after your last dose of this medicine (Syndros).
• This medicine has alcohol and propylene glycol in it. Preterm newborns may have a higher chance of very bad and sometimes deadly side effects caused by propylene glycol. If you have questions, talk with the doctor or pharmacist.
• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking this medicine (Syndros) outweigh the risks. If your child has been given this medicine (Syndros), ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this medicine (Syndros) to your child.
• Use with care in children. Talk with the doctor.
• If you are 65 or older, use this medicine (Syndros) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (Syndros), call your doctor right away.

How is Syndros best taken?

Use this medicine (Syndros) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• If you are using this medicine (Syndros) to help you eat more, take this medicine (Syndros) 1 hour before lunch and dinner or as your doctor has told you.
• If you are using this medicine (Syndros) to treat upset stomach and throwing up, follow what your doctor has told you to do about taking this medicine (Syndros) with or without food.
• Only use the measuring device that comes with this liquid drug.
• Take with a full glass of water.
• Those who have feeding tubes may use this medicine (Syndros). Use as you have been told. Flush the feeding tube after this medicine (Syndros) is given.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Syndros that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Mental, mood, or behavior changes that are new or worse.
• Hallucinations (seeing or hearing things that are not there).
• A fast heartbeat.
• Memory problems or loss.
• Not able to focus.
• Change in balance.
• Feeling very sleepy.
• Feeling confused.
• Seizures.
• Stomach pain, upset stomach, or throwing up that is new or worse.
• Mouth sores.
• Burning.
• Flushing.

What are some other side effects of Syndros?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Feeling high (easy laughing and feeling good).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Syndros?

• Store unopened bottles in the refrigerator. Do not freeze.
• After opening, store at room temperature or in a refrigerator. Throw away any part not used after 6 weeks.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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