Symproic

Symproic is a prescription medication used for the treatment of constipation caused by strong pain medications called opioids in adults with non-cancer pain.  

Symproic is in a class of medications called mu-opioid receptor antagonists. It works by blocking the effects of the pain medication in your gut and prevents constipation from happening.

This medication is available as a tablet and is typically taken once a day with or without food. 

Common side effects of Symproic include stomach pain, diarrhea, and nausea. Symproic may also cause opioid withdrawal symptoms such as hot flushes, chills, fever and sweating. 

Symproic is a prescription medication used in adults for the treatment of constipation caused by strong pain medication called opioids. Symproic is used only in patients who are using opioid pain treatment to treat ongoing pain unrelated to cancer and have a consistent opioid dose (typically being taken for 4 weeks). 

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

Serious side effects have been reported with Symproic. See the "Symproic Precautions” section.

Common side effects of Symproic include the following:

• stomach pain
• diarrhea
• nausea
• gastroenteritis (stomach flu)

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

Tell your doctor if you have any side effects that bother you or that do 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. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole)
• medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil), itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Quinact, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)
• other opioid antagonists such as naloxone (Narcan) or naltrexone (Revia, Vivitrol)

This is not a complete list of Symproic drug interactions. Ask your doctor or pharmacist for more information.

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

Tear in the stomach or intestinal wall. Contact your doctor immediately if you develop severe stomach pain that does not go away. 

Opioid withdrawal. Contact your doctor if you develop chills, sweating, watery eyes, hot flushes, fever, stomach pain, diarrhea, nausea, or vomiting.

Do not take Symproic if you:

• are allergic to Symproic or to any of its ingredients
• have or have had a bowel blockage (intestinal obstruction) 

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 Symproic, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Symproic or to any of its ingredients
• have any stomach or intestine problems such as a stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome
• have liver problems
• are pregnant or plan to become pregnant 
• are breastfeeding or plan to breastfeed

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

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

There are no well-controlled studies that have been performed in pregnant women. As a result, there is not enough data to determine the drug-associated risk of birth defects and miscarriage when given during pregnancy. Symproic may lead to opioid withdrawal in a fetus if used in pregnant women. 

Symproic should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

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

There is no data regarding Symproic's presence in human breast milk.

There is, however, data showing Symproic's presence in the milk of rats. 

Because of the possibility of serious adverse reactions such as opioid withdrawal in nursing infants, a choice should be made whether to stop nursing or to stop Symproic use. The importance of the drug to the mother should be considered.

Take Symproic exactly as prescribed.

Symproic is a 0.2 mg tablet taken once daily with or without food. Stop taking Symproic if opioid pain medication is stopped.

This medication has been shown to be effective in people who have taken opioid pain medicines for at least 4 weeks.

If you miss a dose of Symproic, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Symproic at the same time.

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

The recommended dose of Symproic for the treatment of opioid induced constipation is 0.2 mg (one tablet) every day. 

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

• Store Symproic at room temperature in a light-resistant container.
• Keep out of reach of children.