Medication info

Amity Natural Soft Capsule 24 Micrograms (Lubiprostone)

Prescription medicationSoft capsule경구Approval withdrawn
Ingredient · strength
Lubiprostone›24μg / 1 capsule
Manufacturer / importer
제일약품(주)
Appearance
Orange oval soft capsule containing a transparent content
Packaging
PTP packaging: 4 capsules / carton, 10 capsules / carton, 60 capsules / carton
Approval status
Approval withdrawn

MFDS item code 201903208 · Approved 2019.05.17

This product's status changed to Approval withdrawn on 2024.02.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic idiopathic constipation and constipation induced by opioid analgesics
Who takes it
Adults
Adult dose
This medication should be taken orally, twice daily, with food and water. It must be swallowed whole and not split or chewed. The recommended dosage for chronic idiopathic constipation and opioid analgesic-induced constipation is 24 mcg twice daily. For patients with moderate liver dysfunction, the recommended starting dose is 16 mcg twice daily, while those with severe liver dysfunction should start with 8 mcg twice daily. Dosage for patients with kidney impairment

Ingredients

Importer
제일약품(주)

Efficacy & effects

Treatment of chronic idiopathic constipation and constipation induced by opioid analgesics

  • Chronic idiopathic constipation
  • opioid analgesic-induced constipation
View approved original text

This medication is used to treat chronic constipation occurring in adults without any specific cause. It also helps alleviate constipation symptoms occurring in adult patients who are taking opioid analgesics. However, it should be noted that its effectiveness is not yet fully proven in patients taking diphenylheptane class opioids (e.g. methadone). Overall, this drug is effective in improving chronic constipation issues.

How to take

Adult dose

This medication should be taken orally, twice daily, with food and water. It must be swallowed whole and not split or chewed. The recommended dosage for chronic idiopathic constipation and opioid analgesic-induced constipation is 24 mcg twice daily. For patients with moderate liver dysfunction, the recommended starting dose is 16 mcg twice daily, while those with severe liver dysfunction should start with 8 mcg twice daily. Dosage for patients with kidney impairment

Precautions

This drug should not be used in certain patients. First, individuals allergic to this drug's ingredients should not take it, and those with suspected bowel obstruction should also avoid it. Women who are pregnant or may become pregnant should not use this drug. Patients with moderate to severe liver dysfunction and those with severely impaired kidney function should exercise greater caution when using this drug. Side effects such as nausea, diarrhea, headache, abdominal pain, and abdominal distension can commonly occur during the use of this medication. In particular, nausea and diarrhea may manifest severely in some patients, sometimes leading to the cessation of treatment. If severe diarrhea occurs, medication should be discontinued immediately, and medical advice should be sought. Additionally, this drug may cause fainting or hypotension, necessitating caution; if these symptoms appear, medical professionals should be notified immediately. Some patients may experience dyspnea, so prompt professional help should be sought if this symptom occurs. The effects of this drug on driving or operating machinery are unclear, so caution is advised. Pregnant or breastfeeding women should avoid taking this drug, and safety and efficacy in children under 18 have not been established. In case of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, so the prescribed dosage must be strictly observed. This medication should be stored out of reach of children and kept away from light and extreme temperatures, and it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary symptoms

Mild side effects

  • Nausea
  • diarrhea
  • headache
  • abdominal pain
  • abdominal distension
  • bloating
  • vomiting
  • loose stools
  • abdominal discomfort
  • dyspepsia
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  • thirst
  • dizziness
  • edema
  • fatigue
  • chest discomfort/pain
  • peripheral edema
  • blood and lymphatic system disorders
  • appetite loss
  • muscle cramps
  • fecal incontinence
  • sweating
  • pharyngitis
  • bowel dysfunction
  • anxiety
  • cold sweats
  • cough
  • taste disorders
  • belching
  • influenza
  • joint swelling
  • myalgia
  • pain
  • tremors
  • syncope
  • weakness
  • flushing

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees to maintain its effectiveness and safety for a longer time.

Appearance and packaging

Appearance

Orange oval soft capsule containing a transparent content

Package unit

PTP packaging: 4 capsules / carton, 10 capsules / carton, 60 capsules / 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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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.