Medication info

Coolprep Gold Powder

Prescription medication경구
Ingredient · strength
Polyethylene Glycol 3350›18gAnhydrous Sodium Sulfate›17.5gSodium Chloride›1gPotassium Chloride›0.5gSimethicone›0.16gAscorbic Acid›9g
Manufacturer / importer
(주)태준제약
Appearance
1) Product A: A white or yellowish powder in an aluminum foil pouch with a mangosteen flavor. 2) Product B: A white crystalline or crystalline powder in an aluminum foil pouch with no odor and a sour taste.
Packaging
Product A: 1 pouch (39.675g) x 2 pouches / carton, Product B: 1 pouch (9.0g) x 2 pouches / carton
Approval status
Active

MFDS item code 202402305 · Approved 2024.09.24 · Insurance code 650103321

Summary

Main use
Effect of bowel cleansing before colonoscopy and X-ray examination
Who takes it
Adults
Adult dose
[Preparation of the solution] In a translucent plastic container, place one pouch each of products A and B, add appropriate amount of water, dissolve, and then fill with water up to the 400mL mark, shaking well to prepare the solution. [Method of administration] 1) Two-day split dosing method: Prepare 400mL of the solution according to the preparation method the evening before the exam and consume it within 30 minutes. Afterward, drink 400mL of water in two portions within 1 hour. The next morning, prepare 400mL of the solution again according to the preparation method, consume it within 30 minutes, and then drink 400mL of water in two portions within 1 hour. This process must be completed at least 2 hours before the examination starts. Drink the solution immediately after preparation, and any unused or leftover solution should be discarded. 2) Same-day split dosing method: On the morning of the exam, prepare 400mL of the solution according to the preparation method and consume it within 30 minutes. Afterward, drink 400mL of water in two portions within 1 hour. 1-2 hours later, prepare another 400mL of the solution as per the preparation method and drink it within 30 minutes, then again drink 400mL of water in two portions within 1 hour. This process must also be completed at least 2 hours before the examination starts. Drink the solution immediately after preparation, and any unused or leftover solution should be discarded.

Ingredients

Manufacturer
(주)태준제약

Efficacy & effects

Effect of bowel cleansing before colonoscopy and X-ray examination

View approved original text

This medication is used to thoroughly cleanse the bowel prior to a colonoscopy or a colon X-ray examination. It helps remove residues and impurities remaining in the bowel, facilitating a smooth examination process. Proper preparation of the bowel before the examination increases the accuracy of the test results. Therefore, this medication is taken to cleanse the bowel before undergoing a colon examination.

How to take

Adult dose

[Preparation of the solution] In a translucent plastic container, place one pouch each of products A and B, add appropriate amount of water, dissolve, and then fill with water up to the 400mL mark, shaking well to prepare the solution. [Method of administration] 1) Two-day split dosing method: Prepare 400mL of the solution according to the preparation method the evening before the exam and consume it within 30 minutes. Afterward, drink 400mL of water in two portions within 1 hour. The next morning, prepare 400mL of the solution again according to the preparation method, consume it within 30 minutes, and then drink 400mL of water in two portions within 1 hour. This process must be completed at least 2 hours before the examination starts. Drink the solution immediately after preparation, and any unused or leftover solution should be discarded. 2) Same-day split dosing method: On the morning of the exam, prepare 400mL of the solution according to the preparation method and consume it within 30 minutes. Afterward, drink 400mL of water in two portions within 1 hour. 1-2 hours later, prepare another 400mL of the solution as per the preparation method and drink it within 30 minutes, then again drink 400mL of water in two portions within 1 hour. This process must also be completed at least 2 hours before the examination starts. Drink the solution immediately after preparation, and any unused or leftover solution should be discarded.

Precautions

This medication may rarely cause generalized tonic-clonic seizures even in patients without a history of seizures. Caution is advised for patients with electrolyte abnormalities or those taking medications that can increase the risk of electrolyte abnormalities. It should not be administered to patients with bowel obstruction, gastrointestinal obstruction, perforation, toxic colitis, or toxic megacolon, and should be used with caution in patients with severe ulcerative colitis. When used as a bowel pre-treatment, serious arrhythmias, such as atrial fibrillation, have been reported rarely, thus caution is necessary for patients with risk factors for heart disease or electrolyte imbalances. This medication contains lactose and should not be given to patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It should not be administered to patients with hypersensitivity reactions, gastrointestinal obstruction, perforations, dehydration, severe heart failure, a history of cardiac arrest, conditions causing significant mucosal damage in the colon, gastroparesis, glucose-6-phosphate dehydrogenase deficiency, comatose patients, and children under 18 years of age. Caution should be exercised in elderly patients, those with bowel strictures, severe constipation, frail individuals, vomiting reflex impairment, altered consciousness, severe renal impairment, acute severe inflammatory diseases, dysphagia, and those with severe abdominal distension or pain, as well as in patients who have a risk of arrhythmias, or are suspected of anemia or dizziness. Various adverse reactions may occur with the administration of this medication, including nausea, vomiting, abdominal pain, abdominal distension, headaches, dizziness, and hypertension, necessitating immediate consultation with a healthcare provider if symptoms arise. Before and after administration, it is essential to check for proper bowel movements. If there is severe abdominal distension or pain, the administration rate should be adjusted or stopped. If symptoms such as swelling, difficulty breathing, or increased fatigue occur, an electrolyte test should be carried out and treated appropriately. Sufficient hydration is necessary during this medication period, and it is important to drink additional water after taking the medication. This medication contains sodium and potassium; hence, patients who need to regulate their intake of these elements, or those with compromised renal function, should exercise caution. Caution should also be taken to avoid using this medication and stimulant laxatives together, as it may increase the risk of mucosal ulcers or ischemic colitis. It is advisable to avoid using this medication during pregnancy, and breastfeeding mothers should consider the potential risks to the newborn, as it is not known whether this medication's components are excreted in breast milk. Safety and efficacy in pediatric patients have not been established; hence, it should not be administered to patients under 18 years of age. Elderly patients may have increased sensitivity to the medication, necessitating caution during administration. In case of overdose, electrolyte imbalances, dehydration, and reduced blood volume may occur, thus patients should be closely monitored and treated as required. Do not add other ingredients or flavorings before administration. Once dissolved, it should be taken immediately, and any remaining solution should be discarded. Store out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthmatic episodes, respiratory distress accompanied by cough and fever, hypoxia, yellowing of the skin or eyes, profound lethargy, liver abnormalities, sudden and severe headache.

Mild side effects

Nausea, vomiting, abdominal pain, abdominal distension, chronic gastritis, Helicobacter pylori gastritis, lethargy, thirst, dizziness, headache, hypertension, increased alanine aminotransferase, increased aspartate aminotransferase, abnormal blood creatine phosphokinase levels, nausea, dyspepsia, anal discomfort, upper abdominal pain, lower abdominal pain, dysphagia, sleep disturbances, dizziness, migraine, drowsiness, malaise, thirst, fatigue, weakness, chills, pain.

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

1) Product A: A white or yellowish powder in an aluminum foil pouch with a mangosteen flavor. 2) Product B: A white crystalline or crystalline powder in an aluminum foil pouch with no odor and a sour taste.

Package unit

Product A: 1 pouch (39.675g) x 2 pouches / carton, Product B: 1 pouch (9.0g) x 2 pouches / carton

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.