Medication info

Colyte

Prescription medication경구Approval withdrawn
Ingredient · strength
Polyethylene Glycol 3350›29.5g / 1 packetAnhydrous Sodium Sulfate›2.85g / 1 packetSodium Bicarbonate›0.84g / 1 packetSodium Chloride›0.73g / 1 packetPotassium Chloride›0.37g / 1 packet
Manufacturer / importer
(주)태준제약
Appearance
Colorless to white powder contained in a pouch
Packaging
1 pouch (34.65g) x 8 pouches / carton
Approval status
Approval withdrawn

MFDS item code 198902191 · Notified 1989.10.11

This product's status changed to Approval withdrawn on 2025.07.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Laxative effect for bowel preparation prior to colorectal and abdominal surgery
Who takes it
Adults
Adult dose
Dissolve the powder from 1 pouch in a suitable amount of water and fill with additional water up to the 500 mL mark, shaking well to ensure uniformity before consumption. For adult gastrointestinal examination preparation, a 4 L solution of this drug is appropriate. The method of administration is to rapidly consume 250 mL of the solution every 10 minutes until rectal discharge is clear or until a total of 4 L has been consumed.

Ingredients

Manufacturer
(주)태준제약

Efficacy & effects

Laxative effect for bowel preparation prior to colorectal and abdominal surgery

View approved original text

This laxative is used to clean the bowel before colon X-ray exams, colonoscopies, rectal examinations (for hernia, hemorrhoids), intravenous urography, and abdominal surgeries. It effectively clears the bowel prior to these procedures, assisting in accurate diagnoses and safe surgeries. Thus, it is important to use a laxative in these situations.

How to take

Adult dose

Dissolve the powder from 1 pouch in a suitable amount of water and fill with additional water up to the 500 mL mark, shaking well to ensure uniformity before consumption. For adult gastrointestinal examination preparation, a 4 L solution of this drug is appropriate. The method of administration is to rapidly consume 250 mL of the solution every 10 minutes until rectal discharge is clear or until a total of 4 L has been consumed.

Precautions

This medicine should not be used in patients with known allergic reactions to this drug or its components. It should not be administered in cases of suspected or confirmed gastrointestinal obstruction or perforation. It may pose risks for patients with severe dehydration or heart failure. Patients with colonic disorders such as toxic colitis or toxic megacolon are also excluded from treatment. Safety has not been established in patients with atrophic gastritis or in pediatric patients. Use with caution in patients with narrowed intestines, severe constipation, elderly patients, and frail patients. Care is needed for patients with diminished gag reflex or altered consciousness, as there is a risk of aspiration pneumonia for those using a nasogastric tube. Patients with severe abdominal distension or pain, and those with severe ulcerative colitis should also be monitored closely. Rarely, serious allergic reactions such as anaphylaxis may occur, requiring careful observation of the patient. Serious intestinal problems such as intestinal perforation, bowel obstruction, or incarcerated hernias may also arise, so administration should be stopped immediately if any unusual symptoms occur. In patients over 60 years old, serious adverse effects including gastric mucosal damage, esophageal perforation, heart problems, and pulmonary edema have been reported, requiring caution. The most common side effects include nausea and abdominal distension, and may also include vomiting, abdominal cramps, and anal irritation, though these are generally temporary. Hypersensitivity reactions such as hives, runny nose, dermatitis, and itching may occur. Various adverse reactions have been reported including those affecting the cardiovascular, gastrointestinal, neurological, and renal systems; immediate consultation with healthcare professionals is necessary if any unusual symptoms occur. Before and during the use of this drug, patients should have their bowel movements checked to ensure appropriate bowel activity is occurring. Bowel activity generally begins about 1 hour after administration, and abdominal distension may occur beforehand; if this symptom worsens, the rate of administration should be adjusted or halted. If symptoms such as edema, shortness of breath, or increased fatigue occur, electrolyte testing should be conducted and treatment provided if necessary. Patients who are frail or have impaired renal function, as well as those at risk of heart disease or electrolyte imbalance, should undergo regular blood tests and EKGs. This drug can induce diarrhea, making adequate hydration crucial. Additionally, concomitant use with stimulant laxatives may increase the risk of ulcers on the colonic mucosa or ischemic colitis; thus, co-administration should be avoided. The effects of this drug on driving or operating machinery are not clearly established, so caution is advised. Medications taken within 1 hour before administration may hinder absorption in the gastrointestinal tract due to this drug. The safety for pregnant or breastfeeding women has not been established, and it should only be used when the benefits outweigh the risks. The safety and effectiveness of this drug have not been proven in children; therefore, it should not be used in this population. Elderly patients should be treated with caution, and overdose may result in severe diarrhea necessitating adequate hydration and symptomatic treatment. This medication should not have other components or flavorings added to it; it should be used within 48 hours after being dissolved in water, and any remaining solution should be discarded. Keep out of reach of children and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, anaphylactic reactions (severe allergic reactions), intestinal perforation, bowel obstruction, incarcerated hernia, gastric mucosal damage, esophageal perforation, sudden shortness of breath with heart failure, pulmonary aspiration findings, difficulty breathing, chest tightness, tongue swelling, facial swelling, lip swelling, severe swelling, elevated blood pressure, heart failure, deep vein thrombosis, atrial fibrillation, fainting, dehydration, bleeding due to Mallory-Weiss tear, seizures, renal dysfunction.

Mild side effects

  • Nausea
  • abdominal distension
  • vomiting
  • abdominal cramps
  • anal irritation
  • runny nose
  • dermatitis
  • itching
  • rash
  • fever
Show 2 more
  • chills
  • tremors

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and moisture. This helps maintain the effectiveness of the drug.

Appearance and packaging

Appearance

Colorless to white powder contained in a pouch

Package unit

1 pouch (34.65g) x 8 pouches / carton

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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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.