Medication info

Prucalopride Succinate 2 mg Tablets

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›2.642mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (7 tablets x 4 PTP) / box
Approval status
Expired

MFDS item code 201902316 · Approved 2019.04.16

This product's status changed to Expired on 2024.04.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms related to chronic constipation
Who takes it
Adults
Adult dose
This drug is administered orally and can be taken at any time during the day regardless of meals. Adults: 2mg once a day Elderly over 65 years: The initial dose is 1mg once a day, which can be increased to 2mg once a day if needed. Patients with renal impairment: For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), 1mg once a day will be administered. No dosage adjustment is needed for patients with mild to moderate renal impairment.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Improvement of symptoms related to chronic constipation

  • Symptoms of chronic constipation
View approved original text

This medicine is used for adult patients with chronic constipation symptoms who find it difficult to alleviate symptoms even with the use of laxatives. This drug promotes intestinal motility to aid smooth bowel movements and effectively improves discomfort related to constipation. Therefore, it can help in the long-term management of chronic constipation.

How to take

Adult dose

This drug is administered orally and can be taken at any time during the day regardless of meals. Adults: 2mg once a day Elderly over 65 years: The initial dose is 1mg once a day, which can be increased to 2mg once a day if needed. Patients with renal impairment: For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), 1mg once a day will be administered. No dosage adjustment is needed for patients with mild to moderate renal impairment.

Precautions

This medicine should not be used by certain patients. First, those allergic to the ingredients or additives of this drug should not take it. Second, patients with severe renal impairment requiring dialysis should not take this drug. Third, patients with structural or functional problems in the intestines that may lead to perforation or obstruction, or those with severe intestinal inflammatory diseases such as Crohn's disease and ulcerative colitis should not take this drug. Fourth, since this drug contains lactose, individuals with lactose intolerance or certain genetic metabolic disorders should not take this drug. This drug should be used cautiously in patients with very poor kidney function with a reduced dosage. Additionally, since the safety of this drug has not been sufficiently studied in patients with serious illnesses such as liver, heart, lung, or nervous system disorders, caution is necessary. Patients with a history of arrhythmias or ischemic heart disease should also be particularly careful when using this drug. In patients with severe liver disease, the dosage should be reduced and administered cautiously. Caution is required when this drug is taken with other medications that can affect heart rhythm. The most commonly reported side effects when taking this drug are headaches and gastrointestinal symptoms, with abdominal pain, nausea, and diarrhea occurring in about 20% of patients. Most side effects tend to appear early in treatment and naturally dissipate over time. Other reported side effects include dizziness, tremors, palpitations, vomiting, dyspepsia, rectal bleeding, increased urination, fatigue, fever, malaise, abdominal bloating, abdominal discomfort, gastroesophageal reflux disease, rectal pain, hemorrhoids, functional gastrointestinal disorders, esophagitis, duodenal ulcers, nasopharyngitis, bronchitis, herpes zoster, athlete's foot, bacterial vaginosis, bacterial bronchitis, facial swelling, chest discomfort, and slurred speech. If new palpitations occur, it is imperative to consult a physician. In cases of severe diarrhea, the effectiveness of oral contraceptives may decrease, so it is advisable to use additional contraceptive methods. This drug has a relatively low potential for drug interactions; however, caution is needed when taken with certain antifungal agents or heart-related medications. Additionally, drugs like atropine may reduce the efficacy of this drug. No special interactions have been reported when taken with food. Experience with the use of this drug during pregnancy is limited, and it is not recommended during pregnancy. Women of childbearing age should use effective contraception while taking this drug. The use of this drug is also not recommended in nursing mothers due to the potential for drug exposure to the infant. It is advisable to avoid the use of this drug in children and adolescents under the age of 18. In cases of overdose, symptoms such as headaches, nausea, and diarrhea may occur, and as there are no specific antidotes, it is important to receive appropriate treatment according to the symptoms. If excessive fluid loss occurs due to overdose, electrolyte supplementation may be necessary. This drug may cause dizziness and fatigue, especially in the initial usage, so caution should be exercised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Chest discomfort

Mild side effects

Headaches, gastrointestinal symptoms (abdominal pain, nausea, diarrhea), dizziness, tremors, palpitations, vomiting, dyspepsia, rectal bleeding, borborygmi, increased urination, fatigue, fever, malaise, abdominal bloating, abdominal discomfort, gastroesophageal reflux disease, rectal pain, hemorrhoids, functional gastrointestinal disorders, esophagitis, duodenal ulcers, nasopharyngitis, bronchitis, herpes zoster, athlete's foot, bacterial vaginosis, bacterial bronchitis, facial swelling, chest discomfort, slurred speech.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a container that does not allow light and is well-ventilated, avoiding humid places. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (7 tablets x 4 PTP) / box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.