Naldemedine was developed by Japan Yanno Pharmaceutical Co., Ltd., and has been approved for listing in the United States, the European Union, Japan, Taiwan, China, China, Hong Kong and other places.

1、 Drug name

1. Product Name: SymproicTablets 0.2mg.

2. Common name: Naldemedine Tosilate.

2、 Indications

Used to treat opiate induced constipation (OIC), which is constipation caused by opioid drugs.

3、 Specifications and characteristics

1. Specification: Each tablet contains 0.2mg of nadir (calculated as nadir free base).

2. Appearance: Yellow circular film coated tablets.

4、 Main components

1. Active ingredient: Nalidic acid (0.2604mg/tablet, equivalent to 0.2mg of nadir).

2. Accessories: D-mannitol, cross-linked carboxymethyl cellulose sodium, magnesium stearate, hydroxypropyl methylcellulose, talc powder, yellow iron oxide.

5、 Usage and dosage

1. Conventional dose: Adults take 0.2mg orally once a day.

2. Attention:

It should be used simultaneously with opioid drugs, and if opioid drugs are discontinued, this drug should be discontinued simultaneously.

No need to adjust the dosage based on kidney or liver function.

6、 Dose adjustment

No regular dose adjustment is required, but caution should be exercised when combined with other drugs such as CYP3A inhibitors or P-glycoprotein inhibitors.

7、 Medication precautions

1. Before and after meals: can be taken on an empty stomach or after meals, but taking after meals may delay absorption (Tmax extended from 0.75 hours to 2.5 hours).

2. Missed dose: No need to supplement, continue taking according to the original plan for the next dose.

3. Vomiting: If vomiting occurs after taking medication, there is no need to take additional medication.

8、 Medication for special populations

1. Pregnant women: Use only when the benefits outweigh the risks (animal studies show risks of miscarriage and premature birth).

2. Breastfeeding period: It is recommended to weigh the pros and cons of breastfeeding (animal experiments show milk migration).

3. Children: Safety and efficacy data have not been established.

4. Elderly: No need to adjust dosage.

5. Patients with liver/kidney dysfunction: mild to moderate without adjustment, severe with caution.

9、 Adverse reactions

1. Common symptoms include diarrhea (21.3%), abdominal pain, vomiting, and decreased appetite.

2. Serious: severe diarrhea (0.7%), gastrointestinal perforation (rare), and anxiety, nausea, etc.

10、 Contraindications

1. People who are allergic to ingredients.

2. Patients with gastrointestinal obstruction or suspected obstruction (which may cause perforation).

11、 Drug interactions

1. CYP3A inhibitors (such as itraconazole): may increase blood drug concentration and require monitoring for side effects.

2. CYP3A inducers (such as rifampicin): may reduce efficacy.

3. P-glycoprotein inhibitors (such as cyclosporine): increase the risk of brain concentration.

12、 Storage method

Store at room temperature, avoid light, and have a shelf life of 3 years.

Naldemedineinformation