Syndros

Syndros is a prescription medication used to treat nausea and vomiting caused by chemotherapy and is used to treat loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS).

Syndros belongs to a group of drugs called cannabinoids. Syndros is a synthetic version of delta-9-THC, a naturally occurring cannabinoid and the main psychoactive component in marijuana. While it is unknown exactly how Syndros works, the drug is believed to produce its effects by binding to cannabinoid receptors found in the central nervous system.

This medication comes in oral solution and is taken 1 to 3 hours before chemotherapy and then every 2 to 4 hours after chemotherapy, for a total of 4 to 6 doses a day.

When Syndros is used to increase appetite, it is usually taken 2 times a day, before lunch and supper, or once a day in the evening or at bedtime.

Common side effects of Syndros include dose related "high" (easy laughing and elevated mood), dizziness, confusion, and drowsiness.

Do not drive, operate heavy machinery, or engage in hazardous activity until you know how this medication affects you.

Syndros is a prescription medication used to treat nausea and vomiting caused by chemotherapy in people who have already taken other medications to treat this type of nausea and vomiting without good results. Syndros is also used to treat loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Syndros. See the “Syndros Precautions” section.

Common side effects of Syndros include the following:

• dizziness
• feeling extremely happy (euphoria)
• overly suspicious or feeling people want to harm you (paranoid reaction)
• sleepiness
• abnormal thoughts
• stomach-area (abdominal) pain
• nausea
• vomiting

This is not a complete list of Syndros side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Syndros contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take Syndros. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking Syndros and within 7 days after your last dose of Syndros. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing. 

Serious side effects have been reported with Syndros including the following:

• Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take Syndros. Syndros taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take Syndros may have a greater risk of having psychiatric symptoms. Tell your doctor immediately if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
• Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
• Changes in your blood pressure. Syndros may increase or decrease your blood pressure, especially when you start taking Syndros or when your dose is changed. Tell your doctor immediately if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling light-headed, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
• Interactions with disulfiram or metronidazole. Syndros contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take Syndros. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking Syndros and within 7 days after your last dose of Syndros. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing.
• Syndros can cause drowsiness. Do not drive or operate heavy machinery until you know how Syndros affects you.

Do not take Syndros if you:

• have had an allergic reaction to Syndros. Signs and symptoms of an allergic reaction include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
• have had an allergic reaction to alcohol.
• are using a medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulfiram or metronidazole in the last 14 days.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Syndros, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Syndros, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or had heart problems
• have or had problems with drug abuse or dependence
• have or had problems with alcohol abuse or dependence
• have or had mental health problems including mania, depression or schizophrenia
• have had a seizure or have a medical condition that may increase your risk of having a seizure
• are pregnant or plan to become pregnant. Syndros may harm your unborn baby. Avoid the use of Syndros if you are pregnant.
• are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if Syndros passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Syndros. Do no breastfeed while taking Syndros and for 9 days after your last dose of Syndros if you are being treated for nausea and vomiting caused by anti-cancer medicine.

Tell your doctor about all the medicines you take or have taken in the last 14 days, including prescription and over-the counter medicines, vitamins, and herbal supplements. Syndros and certain other medicines can affect each other, causing serious side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

Syndros, a synthetic cannabinoid containing alcohol, may cause fetal harm.

Avoid the use of Syndros if you are pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Because of the possible adverse effects from Syndros on the breastfeeding infant, women with nausea and vomiting associated with cancer chemotherapy should not breastfeed during treatment with Syndros and for 9 days after the final dose.

For mothers infected with the Human Immunodeficiency Virus (HIV), the Centers for Disease Control and Prevention recommend not to breastfeed their infants to avoid risking transmission of HIV.

Take Syndros exactly as prescribed.

For the loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS):

• Syndros comes in an oral solution and is taken twice daily, one hour before lunch and dinner to aid appetite in HIV patients.

For the treatment nausea and vomiting caused by chemotherapy:

• Syndros comes in an oral solution and is taken 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day. Take the first dose on an empty stomach at least 30 minutes prior to eating; subsequent doses can be taken without regard to meals.

Always use the enclosed calibrated oral dosing syringe.

The calibrated oral syringe measures a maximum Syndros dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe.

Take Syndros with a full glass of water (6 to 8 ounces).

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your body surface area
• the condition being treated

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Syndros for the treatment of nausea and vomiting caused by chemotherapy is 2.1 mg/m2 to 12.6 mg/m2 per dose. Maximum Dosage: 12.6 mg/m2 per dose for 4 to 6 doses per day.

The recommended dose range of Syndros for the treatment of loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS) is 2.1 mg to 8.4 mg twice daily. Maximum Dosage: 8.4 mg twice daily.

If you take too much Syndros, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store in a refrigerator between 2°C and 8°C (36°F and 46°F) before opening
• The opened bottle can be stored at 25°C (77°F).
• Discard unused portion 28 days after first opening
• Keep Syndros oral solution and the oral syringe in the supplied carton.