Naldemedine Tablet

GENERIC NAME(S): Naldemedine

Uses

Uses

This medication is used to treat constipation caused by opioid (narcotic) medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Naldemedine belongs to a class of medications known as opioid antagonists.

How to use Naldemedine Tablet

Read the Medication Guide provided by your pharmacist before you start taking naldemedine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

Ask your doctor if you should continue using your usual medications for constipation. This medication is used only for constipation caused by opioids. Stop taking naldemedine when you stop using opioid pain medication unless otherwise directed by your doctor.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Side Effects

Stomach/abdominal pain may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking naldemedine and tell your doctor right away if you have diarrhea that doesn't stop.

Opioid withdrawal symptoms may occur in some people. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, abdominal cramps, diarrhea, mental/mood changes (such as anxiety, confusion, extreme sleepiness, visual hallucinations), unusual yawning.

This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). Stop taking this medication and get medical help right away if any of these very serious side effects occur: severe stomach/abdominal pain that doesn't go away, fever, severe dizziness, fainting, severe nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before taking naldemedine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as blockage, ulcers, tumors, Crohn's disease, diverticulitis), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of naldemedine from your body, which may affect how naldemedine works. Examples include enzalutamide, lumacaftor/ivacaftor, mitotane, rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), among others.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. Sharing it is against the law.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised March 2018. Copyright(c) 2018 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.