What is the most important information I should know about naldemedine?
You should not use this medicine if you have a blockage in your stomach or intestines.
Stop using naldemedine and call your doctor at once if you have severe stomach pain that does not go away (this can lead to serious medical problems).
Tell your doctor if you have symptoms of opioid withdrawal, such as sweating, warmth or tingling, runny nose, watery eyes, vomiting, and diarrhea.
Naldemedine may be habit-forming. Never share this medicine with another person. MISUSE OF HABIT-FORMING MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.
What is naldemedine?
Naldemedine blocks certain effects of opioid medication. An opioid is sometimes called a narcotic.
Naldemedine reduces constipation caused by opioid pain medicine used to treat severe chronic pain. Naldemedine works by treating constipation without reducing the pain-relieving effects of the narcotic.
Naldemedine is used in people who have been taking opioid pain medicine for at least 4 weeks, to treat chronic pain that is not caused by cancer.
Naldemedine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking naldemedine?
You should not use naldemedine if you are allergic to it, or if you have:
- a blockage in your stomach or intestines.
To make sure naldemedine is safe for you, tell your doctor if you have ever had:
- a stomach or intestinal disorder (including Crohn's disease, diverticulitis, or Ogilvie's syndrome);
- stomach cancer, colorectal cancer;
- a perforation (a hole or tear) in your esophagus, stomach, or intestines; or
- drug or alcohol addiction.
If you use naldemedine while you are pregnant, your baby could have opioid withdrawal symptoms. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine may cause opioid withdrawal symptoms in a nursing baby. Do not breast-feed while taking naldemedine, and for at least 3 days after your last dose.
Naldemedine is not approved for use by anyone younger than 18 years old.
How should I take naldemedine?
Naldemedine is usually taken once per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Naldemedine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away naldemedine is against the law.
You may take naldemedine with or without food.
Call your doctor if your symptoms do not improve, or if they get worse.
Store in the original container at room temperature, away from moisture and heat.
Keep track of your medicine. Naldemedine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
After you stop using your pain medication, you should also stop taking naldemedine.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking naldemedine?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of naldemedine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor if you have symptoms of opioid withdrawal: sweating, fever, chills, warmth or tingling in your face, yawning, runny nose, watery eyes, stomach pain, vomiting, and diarrhea.
Stop using naldemedine and call your doctor at once if you have:
- severe diarrhea; or
- severe stomach pain that will not go away (this can lead to serious medical problems).
Common side effects may include:
- nausea, stomach pain; or
- diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect naldemedine?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with naldemedine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about naldemedine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01. Revision date: 11/9/2017.
