Medication info

Donggu Prucalopride 1mg Tablets (Prucalopride Succinate)

Prescription medicationTablet경구Expired
Ingredient · strength
Prucalopride Succinate›1.321mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
White to off-white round film-coated tablets
Packaging
28 tablets/box [(14 tablets/Alu-Alu X 2)]
Approval status
Expired

MFDS item code 202001695 · Approved 2020.03.11

This product's status changed to Expired on 2025.03.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of chronic constipation symptoms
Who takes it
Adults
Adult dose
This medication is taken orally and can be administered at any time of the day, regardless of meals. For adults, take 2mg once daily. For elderly patients over 65 years old, the initial dose is 1mg once daily, which may be increased to 2mg once daily if needed. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), administer 1mg once daily.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

This medication is used to treat chronic constipation symptoms in adult patients who have failed to relieve symptoms with laxatives.

How to take

Adult dose

This medication is taken orally and can be administered at any time of the day, regardless of meals. For adults, take 2mg once daily. For elderly patients over 65 years old, the initial dose is 1mg once daily, which may be increased to 2mg once daily if needed. For patients with severe renal impairment (GFR < 30 ml/min/1.73 m2), administer 1mg once daily.

Precautions

This medication should not be administered to certain patients. First, individuals with allergic reactions to this medication's active ingredients or additives should not take it. Second, this medication is not used in patients with severely impaired kidney function requiring dialysis. Third, patients with functional or structural problems in the intestines, or those suffering from severe inflammatory bowel disease may be at risk if they take this medication. Fourth, because this medication contains lactose, it should not be administered to patients with lactose intolerance or related genetic disorders. Patients with severely reduced kidney function should use this medication cautiously at a reduced dose. Additionally, caution is necessary for patients with severe concomitant diseases such as liver disease, heart disease, lung disease, neurological disorders, cancer, or AIDS. Patients with a history of arrhythmia or ischemic cardiovascular disease should be particularly careful when using this medication. Patients with severely impaired liver function also need dose adjustment. Care should be taken when this medication is used with drugs that can prolong the QTc interval associated with heart rhythm. The most common side effects when taking this medication are headaches and gastrointestinal symptoms, including abdominal pain, nausea, and diarrhea. These symptoms primarily occur early in treatment and often resolve naturally over time. Other reported side effects include dizziness, tremors, palpitations, vomiting, dyspepsia, rectal bleeding, polyuria, and fatigue. If side effects are severe or new heart palpitations occur, consult a doctor. This medication can reduce the efficacy of oral contraceptives if there is severe diarrhea, so additional contraceptive methods are recommended. While the likelihood of drug interactions with other medications is low, caution is needed as blood concentration may increase when taken with specific medications. Special attention should be given when used in combination with medications that increase the risk of QTc interval prolongation. Additionally, drugs with similar actions to atropine may reduce the effectiveness of this medication. It is known that there are no significant interactions with food. There is limited experience regarding use during pregnancy and it is not recommended during pregnancy. Women of childbearing age must use effective contraception while taking this medication. During breastfeeding, this medication may be excreted in breast milk, but it is expected to have minimal effects on the infant, though it is not recommended. This medication is not recommended for use in children or adolescents under the age of 18. In case of overdose, symptoms may include headaches, nausea, and diarrhea, and without a specific antidote, appropriate treatment according to symptoms is necessary. Electrolyte supplementation may be needed for dehydration due to severe diarrhea or vomiting. This medication may cause dizziness and fatigue on the first day of use, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Chest discomfort
  • facial swelling
  • peripheral edema
  • edema

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • dyspepsia
  • rectal bleeding
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  • flatulence
  • abnormal bowel sounds
  • polyuria
  • fatigue
  • fever
  • malaise
  • dyspepsia
  • abdominal bloating
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional dyspepsia
  • loose stools
  • esophagitis
  • duodenal ulcers
  • rhinitis
  • bronchitis
  • herpes zoster
  • athlete's foot
  • bacterial vaginosis
  • bacterial bronchitis
  • facial swelling
  • chest discomfort

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

Storage

This medication should be stored in a container that does not allow light and air to enter, and in a place that avoids excessive moisture. The recommended storage temperature is at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white round film-coated tablets

Package unit

28 tablets/box [(14 tablets/Alu-Alu X 2)]

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.