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Naldemedine was developed by Japan's Shionogi Pharmaceutical Co., Ltd. and has been approved for marketing in the United States, the European Union, Japan, Taiwan, China, and Hong Kong, China.
1. Trade name: Symproic Tablets 0.2mg.
2. Common name: Naldemedine Tosilate.
It is used to treat OIC-induced constipation (OIC) , that is, constipation caused by opioids.
1. Specifications: Each tablet contains 0.2 mg of naldimedine (calculated as naldimedine free base).
2. Characteristics: yellow round film-coated tablets.
1. Active ingredient: ナルデメジントシル acid chloride (0.2604mg/tablet, equivalent to naldimedine 0.2mg).
2. Excipients: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, yellow iron oxide.
1. Conventional dose : Adults take 0.2 mg orally once a day.
2. Precautions :
It needs to be used at the same time as opioids. If opioids are stopped, this medicine needs to be stopped simultaneously.
No dose adjustment is required based on renal or hepatic function.
No routine dose adjustment is required, but caution is required when combined with other drugs (such as CYP3A inhibitors or P-glycoprotein inhibitors).
1. U200c before or after meals: It can be taken on an empty stomach or after a meal, but taking it after a meal may delay absorption (Tmax is extended from 0.75 hours to 2.5 hours).
2. If you miss a dose of , you do not need to take it again. You can continue to take the next dose as originally planned.
3. Vomiting : If you vomit after taking the medicine, there is no need to take a supplement.
1. Pregnant women : Use only when the benefits outweigh the risks (animal tests show the risk of miscarriage and premature birth).
2. Lactation : It is recommended to weigh the pros and cons of breastfeeding (animal experiments show milk migration).
3. Children’s : Safety and effectiveness data have not been established.
4. U200c for the elderly: No dose adjustment is required.
5. People with liver/kidney insufficiency : No adjustment is needed for mild to moderate symptoms, but caution is required for severe symptoms.
1. Common : diarrhea (21.3%), abdominal pain, vomiting, and loss of appetite.
2. Severe : severe diarrhea (0.7%), gastrointestinal perforation (rare), Yuta detachment syndrome (anxiety, nausea, etc.).
1. Those who are allergic to ingredients.
2. Patients with digestive tract occlusion or suspected occlusion (may cause perforation).
1. CYP3A inhibitor (such as itraconazole): may increase blood concentration, and side effects need to be monitored.
2. CYP3A inducer (such as rifampicin): may reduce efficacy.
3. P-glycoprotein inhibitor (such as cyclosporine): increases the risk of brain concentration.
Store at room temperature, protected from light, valid for 3 years.