Symproic is an opioid antagonist. It works by binding to the opioid receptors in your gastrointestinal (GI) tract, kicking out the opioids taking up space and preventing more from attaching and causing constipation. However, naldemedine is designed not to block the action of opioids in the nervous system, so it can cause constipation relief without preventing the painkilling effect of opioids.
The generic name for Symproic is naldemedine, but it’s not currently available to purchase as a generic product. Because it is a prescription medication, your healthcare provider needs to prescribe it for you to pick up from the pharmacy.
Symproic is also a schedule II controlled substance, which means it is carefully tracked and regulated by the Food and Drug Administration (FDA) since it can lead to abuse and dependence.
This medication is available as a tablet for oral use.
What Is Symproic Used For?
Smyproic can help relieve opioid-induced constipation (OIC) in adults treated with opioids for chronic pain. Your healthcare provider will usually prescribe this medication if traditional laxatives do not work.
Brand Name: Symproic
Drug Availability: Prescription
Therapeutic Classification: Opioid antagonist
Available Generically: No
Controlled Substance: Schedule II
Administration Route: Oral
Active Ingredient: Naldemedine
Dosage Form: Tablet
Opioids can cause a range of side effects, one being OIC. Symptoms of OIC include:
Infrequent, hard, or uncomfortable bowel movementsBloatingNausea or vomitingAbdominal discomfort
Opioids relieve pain by attaching to the opioid receptors in your nervous system. However, there are also opioid receptors in the GI tract. When opioids bind to these receptors, it can cause intestinal dryness and slow down the muscles that help you maintain regular bowel movements. This is also called decreased intestinal motility. All of these actions caused by opioids lead to the condition of OIC.
Naldemedine prevents these negative effects by stopping opioids from binding to the receptors in the GI tract while allowing them to relieve pain via your nervous system.
How to Take Symproic
Symproic is usually taken once daily. You can it with or without food.
You will likely not need to change how you take your opioid analgesics to begin taking Symproic, but your healthcare provider will review this with you. Also, let your healthcare provider know if you stop taking opioids, as you will also stop taking Symproic in that case.
Storage
Store Symproic at room temperature (between 68 F and 77 F) in the original container with the lid closed, out of reach of children and pets. Avoid storing it in an area with a lot of heat and moisture, like the bathroom.
If you’re traveling by plane, you’ll want to keep Symproic in your carry-on luggage so that you aren’t separated from it in case your checked baggage goes missing. If you’re traveling by car, take care not to leave your pill bottle in hot or cold temperatures for too long, like overnight in the car.
What Are the Side Effects of Symproic?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
Some common side effects that you may experience while taking Symproic include the following:
Upper or lower abdominal pain Diarrhea Nausea Gastroenteritis, or short-term inflammation of the digestive system: Symptoms are flu-like, including cramping, diarrhea, and vomiting
If these side effects seem severe or do not go away, notify your healthcare provider.
Severe Side Effects
Potential side effects of Symproic that were rarer in clinical trials but potentially more severe include:
Gastrointestinal perforation, or bowel perforation, occurs when a hole is formed in your colon, the last part of your GI tract. This may be more likely if you take Symproic and have other conditions that compromise the walls of your GI tract, such as peptic ulcer disease, diverticular disease, Crohn’s disease, or malignancies in your GI tract. Let your healthcare provider know about any other GI conditions you have before starting Symproic, and be on the lookout for worsening or persistent abdominal pain. Opioid withdrawal occurs when the amount of opioid drugs you are used to having in your system begins to decline, which may occur with Symproic. Symproic’s job is to take the place of opioids in your opioid receptors. While the goal is for this to only happen in your GI tract, it’s still possible for Symproic to work partially in the nervous system as well, resulting in withdrawal symptoms such as sweating, chills, hot flashes, abdominal pain, nausea, or vomiting.
Call your healthcare provider immediately if you feel like you are experiencing serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Long-Term Side Effects
No specific side effects other than those listed above are noted to be associated with longer-term use of Symproic. However, it is worth noting that longer-term use of opioids may be linked to a higher risk of abuse and dependence.
Dosage: How Much Symproic Should I Take?
Modifications
Pregnancy
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For constipation caused by opioids: Adults—0. 2 milligrams (mg) once a day for at least 4 weeks (with narcotic pain medicines). Children—Use and dose must be determined by your doctor.
It’s not known whether taking Symproic while pregnant increases the risk of birth defects or miscarriage. Data with pregnant people on the drug is too limited to make a recommendation, but Symproic does cross the placenta and should only be used during pregnancy if the potential benefit outweighs any risks of exposure or opioid withdrawal in the fetus.
Breastfeeding
It is not known whether Symproic is present in human breast milk or whether it affects milk production. However, based on nonhuman animal studies, it is thought that Symproic does most likely pass into breast milk. For this reason, it is best to decide with your healthcare provider to stop breastfeeding or stop taking Symproic (and opioids in general). If you choose to discontinue the drug, wait until three days have gone by to resume breastfeeding.
Children
The safety of Symproic hasn’t been established in children.
Older Adults
There have not been specific studies to determine whether older adults (above age 65) respond differently to Symproic than younger adults. In general, opioids (and therefore Symproic) should be used cautiously in people 65 and older, keeping in mind any factors that may worsen the risk of side effects. These can include decreased cognitive function and balance, plus longer exposure time to opioids due to slower metabolism.
Missed Dose
If you forget to take a dose of Symproic, you can take it as soon as you remember, then take your next scheduled dose at its regular time.
If you are closer to your next dose than the dose you missed, go ahead and skip the missed dose and wait for your next scheduled one. Do not double up doses to make up for missed ones.
Overdose: What Happens If I Take Too Much Symproic?
As long as you take Symproic once daily as prescribed, you don’t need to be too concerned about overdosing. There is no specific antidote for overdosage with Symproic. Treatment would most likely consist of treating symptoms and monitoring your general condition.
In clinical trials, people who received much higher than recommended doses of Symproic experienced worsened side effects, including abdominal pain, diarrhea, and nausea. Effects were dose-related, meaning the higher the doses, the worse the individual’s side effects were.
Precautions
What Are Reasons I Shouldn’t Take Symproic?
You should not take Symproic if you:
If someone collapses or isn’t breathing after taking Symproic, call 911 immediately.
This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have a severe stomach pain that does not go away.
This medicine may cause withdrawal symptoms. Tell your doctor right away if you have increased sweating, chills, increased tearing, redness on the face, neck, arms, and upper chest, feeling cold, abdominal or stomach pain, diarrhea, nausea, and vomiting.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John’s wort) or vitamin supplements.
Have a history of a hypersensitivity reaction (allergy) to naldemedine. Have or suspect that you have a bowel obstruction or are at increased risk of recurrent obstruction. These conditions would increase your risk for bowel perforation.
What Other Medications Interact With Symproic?
Make sure the healthcare provider prescribing Symproic knows all other medicines and supplements you take, as Symproic has some significant drug interactions.
Symproic is metabolized by certain proteins called cytochromes, which also metabolize other drugs. When these proteins are too busy metabolizing Symproic, other drugs can build up in your system, or vice versa. For this reason, some dose adjustments may need to be made, or you might need to avoid some drugs altogether:
Strong CYP3A inducers such as rifampin, Tegretol (carbamazepine), Dilantin (phenytoin), or St. John’s Wort may cause Symproic to clear faster from your body and not work as well. Other opioid antagonists, such as Narcan (naloxone) and Vivitrol (naltrexone), may further increase the risk of opioid withdrawal when taken with Symproic. CYP3A inhibitors such as Diflucan (fluconazole), Cardizem (diltiazem), Nizoral (ketoconazole), and Norvir (ritonavir) may cause Symproic to remain in your system longer and increase the risk of side effects. P-glycoprotein (P-gp) inhibitors such as Pacerone (amiodarone), captopril, Gengraf (cyclosporine), Cardioquin (quinidine), and Verelan (verapamil) may cause Symproic to remain in your system longer and increase the risk of side effects.
What Medications Are Similar?
Opioid-induced constipation is a common problem for individuals who use narcotics for chronic pain, so a few different options exist to treat OIC:
Amitiza (lubiprostone) is a chloride channel activator, unlike Symproic. It increases fluid secretion of the GI tract to prevent the dryness sometimes caused by opioids. Relistor (methylnaltrexone) is another opioid antagonist like Symproic, available as tablets and as an injection. Movantik (naloxegol) is another opioid antagonist similar to Symproic.
This is a list of drugs similar to Symproic. It is not a list of drugs that you should take along with Symproic. Ask your pharmacist or a healthcare provider if you have questions.
How Can I Stay Healthy While Taking Symproic?
Opioids have a lot of buzz and controversy surrounding them, mainly due to their ability to cause dependence and abuse. This is something to educate yourself about before deciding to use them long-term. In some cases, opioids might be the right treatment choice if other pain therapies don’t work. Just be mindful of side effects, including constipation.
Other methods to prevent or treat constipation can include:
Increasing dietary fiber and fluid intake Maintaining or adding an exercise plan Using over-the-counter (OTC) laxatives
Most types of laxatives are fine choices for preventing constipation, except bulk-forming laxatives, such as psyllium. These are a bad choice as they increase the bulk of the stool, making it even harder for your colon to pass it. If you are starting an opioid medication, or are already on one, talk with your healthcare provider about what laxative choices may work best for you.
