Medication info

Pruzolol Tablets 1 mg (Prucalopride Succinate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Prucalopride Succinate›1.321mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White to off-white round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu * 2)
Approval status
Approval withdrawn

MFDS item code 201900670 · Approved 2019.01.25

This product's status changed to Approval withdrawn on 2024.01.05. 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 during the day, regardless of meals. Adults take 2 mg once daily. Elderly patients over 65 years old may start with 1 mg once daily and can increase to 2 mg once daily if necessary. Patients with severe renal impairment and severe liver impairment should take 1 mg once daily. For mild to moderate renal and liver impairment, dose adjustments are not needed.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement of chronic constipation symptoms

  • Chronic constipation symptoms
View approved original text

Used for the treatment of chronic constipation symptoms in adults when symptoms are not improved with the use of laxatives.

How to take

Adult dose

This medication is taken orally and can be administered at any time during the day, regardless of meals. Adults take 2 mg once daily. Elderly patients over 65 years old may start with 1 mg once daily and can increase to 2 mg once daily if necessary. Patients with severe renal impairment and severe liver impairment should take 1 mg once daily. For mild to moderate renal and liver impairment, dose adjustments are not needed.

Precautions

This medication should not be used in certain patients. It may be dangerous for patients allergic to the active ingredient or excipients, those with severely impaired kidney function, or those with structural or functional problems in the intestines. Additionally, patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with severe kidney impairment should use a reduced dose of this medication, and those with other serious conditions such as liver, heart, or lung diseases should be cautious when taking it. Special care is needed for patients with a history of arrhythmias or ischemic cardiovascular diseases. Patients with severely impaired liver function also need dose adjustments. This medication can commonly cause gastrointestinal symptoms such as headache, abdominal pain, nausea, and diarrhea, typically appearing early in treatment and often resolving over time. If symptoms like palpitations occur, it is advisable to consult a physician. In cases of severe diarrhea, the effectiveness of oral contraceptives may be decreased, so using additional contraceptive methods is recommended. The potential for drug interactions with this medication is low; however, there may be an increased blood concentration when taken with specific drugs, so caution is needed. Special attention is required when used with drugs that may cause QTc prolongation. Use of this medication is not recommended during pregnancy, and women of childbearing age should employ effective contraception during treatment. Nursing mothers are also advised to avoid taking this medication. It is not safe to use this medication in children or adolescents under 18 years of age. In case of overdose, symptoms such as headache, nausea, and diarrhea may occur, and appropriate treatment is necessary based on the symptoms. Fluid and electrolyte replacement may be necessary if excessive diarrhea and vomiting lead to fluid loss. This medication may cause dizziness and fatigue on the first day of intake, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Chest discomfort
  • facial swelling
  • peripheral edema
  • swelling
  • palpitations.

Mild side effects

  • Headache
  • dizziness
  • tremors
  • palpitations
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • indigestion
  • rectal bleeding
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  • bloating
  • abnormal bowel sounds
  • frequent urination
  • fatigue
  • fever
  • malaise
  • abdominal distension
  • abdominal discomfort
  • gastroesophageal reflux disease
  • rectal pain
  • hemorrhoids
  • functional dyspepsia
  • loose stools
  • esophagitis
  • duodenal ulcers
  • nasopharyngitis
  • bronchitis
  • herpes zoster
  • athlete's foot
  • bacterial vaginosis
  • bacterial bronchitis
  • facial edema
  • chest discomfort
  • peripheral edema.

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

Storage

This medication is sensitive to light and moisture, so it should be stored in a container that avoids light and allows good air circulation. Additionally, it is best to avoid extremely hot or cold places and to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu * 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

No questions yet.

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.