Naldemedine (Symproic) is an oral medication specifically designed for the treatment of opioid-induced constipation (OIC). As a selective peripheral μ-opioid receptor antagonist, it relieves constipation symptoms by acting on opioid receptors in the gastrointestinal tract, while avoiding interference with the analgesic effects of the central nervous system.

What Are the Indications of Naldemedine (Symproic)?

Core Indications

Naldemedine is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Its scope of application includes patients with chronic pain related to previous cancer or its treatment, but it excludes cases where opioid doses need to be increased frequently (e.g., weekly).

This medication targets constipation caused by long-term use (for at least 4 weeks) of opioid analgesics. It restores the normal peristaltic function of the intestines by blocking μ-opioid receptors in the gastrointestinal tract.

It should be noted that if a patient discontinues opioid analgesics, naldemedine should also be discontinued at the same time.

Characteristics of Suitable Populations

Clinical trials have shown that naldemedine may be less effective in patients who have received opioid treatment for less than 4 weeks.

It is recommended to be used preferentially in patients with chronic pain who have received long-term opioid treatment (for more than 1 month), especially those who have poor responses to traditional laxatives.

Specifications and Properties of Naldemedine (Symproic)

Dosage Form and Content

Naldemedine is a film-coated oral tablet. Each tablet contains 0.2 mg of naldemedine (equivalent to 0.26 mg of naldemedine tosylate).

The tablet appears as a yellow, round shape. One side is engraved with the Shionogi logo and the code "222", and the other side is marked with the dose "0.2".

Ingredient Composition

In addition to the active ingredient, naldemedine tosylate.

The tablet also contains the following excipients: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow iron oxide.

Storage Conditions for Naldemedine (Symproic)

Storage Requirements

Naldemedine should be stored at room temperature between 20°C and 25°C (68°F and 77°F), with short-term exposure to temperatures ranging from 15°C to 30°C (59°F to 86°F allowed).

The medication should always be stored in its original light-resistant container to avoid moisture, high temperatures, or direct light exposure.

Light Protection Requirement: The yellow coating is designed to reduce the impact of light on the drug ingredients, so the packaging should not be replaced arbitrarily.

Humidity Control: Avoid placing it in humid areas such as bathrooms or kitchens.

Precautions for Use

After opening the medication, the bottle cap should be tightly closed to prevent moisture absorption and deterioration.

Please keep naldemedine out of the reach of children to avoid the risk of accidental ingestion.

If the medication shows changes in color, is damaged, or has expired, its use should be stopped immediately.