• Naldemedine is a peripherally-acting mu-opioid receptor antagonist which was approved by US FDA in March 2017 for the treatment of opioid-induced constipation in patients who have chronic non-cancer pain.
Naldemedine is prescribed for relieving constipation induced by opioid pain medications. It is used in adults who suffer from chronic pain but not due to cancer.
It protects the bowel by blocking the constipating effect of opioid drugs without interfering with their pain-relieving effects.
Naldemedine is generally prescribed in patients who have been taking opioid pain medicines for at least for 4 weeks.
Naldemedine is not recommended in the following:
• Patients who are allergic to naldemedine
• Known or suspected gastrointestinal obstruction
• Stomach or intestinal disorders such as diverticulitis, Crohn's disease or stomach or colorectal cancer due to a risk of perforation
• Severe hepatic impairment. No dose modification is needed in mild-to-moderate liver impairment
• Children less than 18 years of age
• Pregnancy due to the possibility of opioid withdrawal symptom in the newborn
• Breastfeeding should be started only after 3 days of the last dose of naldemedine tablets.
• The recommended adult dose of naldemedine is 0.2 mg once a day.
• Naldemedine comes as a tablet to be taken by mouth and can be taken either with or without food.
• The naldemedine tablets should be taken at the same time each day and exactly as prescribed by the doctor.
• Alteration of opioid dosing regimen is not required before starting the treatment with naldemedine.
• Naldemedine should not be given to the patients who have taken opioids for less than 4 weeks as the response to naldemedine therapy is less than usual in these patients.
• The use of naldemedine should be discontinued when the opioid treatment is stopped.
• Patients should be closely monitored for the development of severe or persistent abdominal pain due to the possibility of a gastrointestinal perforation. Naldemedine should be discontinued when such pain episodes occur.
• Monitor for the opioid withdrawal symptoms in patients who have disruptions of the blood-brain barrier.
• Common: Diarrhea, nausea, stomach pain
• Gastrointestinal: Gastroenteritis, vomiting, loss of appetite, perforation of the digestive tract, bloody stools
• Central nervous system: Symptoms of opioid withdrawal which may include increased sweating or tear formation, chills, flushing, increase in heart rate, fever, sneezing, yawning, anxiety, agitation, tremor, abdominal pain, diarrhea, nausea, and vomiting.
• Allergic reaction: Hives, itching, trouble with breathing, chest tightness or bronchospasm
• The risk-benefit ratio must be considered in patients who are treated with naldemedine because of the possibility of digestive tract perforation or the opioid withdrawal symptoms.
• Drugs such as phenytoin, rifampin, and carbamazepine should not be used along with naldemedine because they reduce the concentration of naldemedine in the blood which leads to decreased naldemedine effect.
• Naldemedine should not be taken with other opioid antagonists such as naloxone or naltrexone as it may lead to additive effect and increased risk of opioid withdrawal symptoms.
• Raised plasma concentrations of naldemedine may occur and lead to naldemedine-related adverse reactions when taken along with following drugs:
Antifungal drugs such as ketoconazole, fluconazole, itraconazole
Antiviral drugs such as ritonavir, saquinavir, atazanavir
Antibiotics such as erythromycin and clarithromycin
Cardiovascular drugs such as amiodarone, quinidine, verapamil, captopril
• Naldemedine tablets should be stored at room temperature between 20°C and 25°C.
• Store in a light-resistant container away from moisture and excessive heat.
• Keep out of reach of children.
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