Medication info

Picolepsan

Prescription medication경구Approval withdrawn
Ingredient · strength
Sodium Picosulfate Hydrate›10mg / 1 packetLight Magnesium Oxide›3.5g / 1 packetAnhydrous Citric Acid›12g / 1 packet
Manufacturer / importer
제일약품(주)
Appearance
Whitish powder with an orange flavor
Packaging
3 sachets/box
Approval status
Approval withdrawn

MFDS item code 201405008 · Approved 2014.10.29

This product's status changed to Approval withdrawn on 2025.04.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Laxative effect for bowel preparation before colonoscopy and surgery
Who takes it
Adults · Children
Adult dose
Take 1 sachet of the prepared solution before 8 AM the day before the examination. Take an additional sachet of the prepared solution 6-8 hours later.
Child dose
Ages 1-2 years: Take 1/4 sachet in the morning and 1/4 sachet in the afternoon the day before the examination. Ages 2-4 years: Take 1/2 sachet in the morning and 1/2 sachet in the afternoon the day before the examination. Ages 4-9 years: Take 1 sachet in the morning the day before the examination.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Laxative effect for bowel preparation before colonoscopy and surgery

View approved original text

Used as a bowel cleansing agent before colon X-ray examinations, colonoscopy, and surgery.

How to take

Adult dose

Take 1 sachet of the prepared solution before 8 AM the day before the examination. Take an additional sachet of the prepared solution 6-8 hours later.

Child dose

Ages 1-2 years: Take 1/4 sachet in the morning and 1/4 sachet in the afternoon the day before the examination. Ages 2-4 years: Take 1/2 sachet in the morning and 1/2 sachet in the afternoon the day before the examination. Ages 4-9 years: Take 1 sachet in the morning the day before the examination.

Precautions

This medication contains the artificial sweetener aspartame, which is broken down in the body into phenylalanine. Thus, patients with phenylketonuria, a genetic disorder that requires restriction of phenylalanine intake, should not take this medication. Patients who have had allergic reactions to this medication or its components should not take it. Patients with congestive heart failure, atrophy, gastrointestinal ulcers, toxic colitis, bowel obstruction, or symptoms of nausea and vomiting should also refrain from using this medication. Additionally, patients with acute abdominal conditions requiring surgical intervention, suspected gastrointestinal obstruction or perforation, severe dehydration, rhabdomyolysis, hypermagnesemia, active inflammatory bowel disease, severe renal dysfunction, or ascites should avoid administration of this medication. Patients who have recently undergone gastrointestinal surgery or have renal dysfunction, heart disease, or inflammatory bowel disease need to use this medication cautiously. Also, patients taking medications affecting fluid or electrolyte balance, such as diuretics, corticosteroids, or lithium, should be careful. Children, the elderly, frail patients, and those at risk for hypokalemia should manage their fluid and electrolyte status closely while using this medication. This medication may cause various side effects, including headaches, nausea, vomiting, abdominal pain, diarrhea, and rashes. Severe allergic reactions such as anaphylaxis may also occur, so if any unusual symptoms appear, notify medical personnel immediately. The effectiveness of bowel cleansing before colon surgery has not been clearly established, so it should only be used when absolutely necessary, and it should not be used for more than 24 hours to avoid the risk of fluid and electrolyte imbalance. Also, this medication cannot be used as a general laxative and may affect the absorption of other oral medications, so caution is needed. This medication speeds up the gastrointestinal transit time and may affect the absorption of other drugs. It is particularly important to be cautious when taken together with antiepileptic drugs, contraceptives, diabetes medications, and antibiotics, and it contains magnesium, so it is necessary to space out the dosage from certain antibiotics or medications. Additionally, if the patient is taking medications related to hypokalemia or NSAIDs, tricyclic antidepressants, etc., which cause fluid retention, the risk of electrolyte imbalance may increase. The safety of this medication during pregnancy has not been established, and reproductive toxicity has been demonstrated in animal studies, so it is advisable to avoid use during pregnancy. While the medication is minimally absorbed in breastfeeding mothers, it may still be used if necessary, but a cautious judgement must be made. In case of overdose, severe diarrhea may occur, requiring adequate fluid intake and appropriate treatment for the symptoms. When taking this medication, dissolve the solution in water and ensure it is at a suitable temperature—neither too hot nor too cold—before drinking, and use opened sachets immediately and discard any remaining medication. The timing of doses may vary depending on the schedule for colonoscopy, so follow the instructions from medical personnel. Lastly, keep this medication out of reach of children, do not transfer it to other containers, and store it in its original container to protect it from moisture.

Side effects and when to seek care immediately

Serious side effects

  • Anaphylactic reactions
  • hypersensitivity
  • urticaria

Mild side effects

Headaches, hyponatremia, hypokalemia, nausea, rectal pain, vomiting, abdominal pain, aphthous intestinal ulcer, diarrhea, fecal incontinence, rashes (erythematous, maculopapular, purpuric inclusive)

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1°C and 30°C at room temperature. By storing it this way, the effectiveness of the medication is well preserved and it can be used safely.

Appearance and packaging

Appearance

Whitish powder with an orange flavor

Package unit

3 sachets/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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.