Medication info

Amity Natural Soft Capsule 8 Micrograms (Lubiprostone)

Prescription medicationSoft capsule경구Approval withdrawn
Ingredient · strength
Lubiprostone›8μg / 1 capsule
Manufacturer / importer
제일약품(주)
Appearance
Pink oval soft capsule containing a transparent content
Packaging
PTP packaging: 4 capsules per carton, 10 capsules per carton, 60 capsules per carton
Approval status
Approval withdrawn

MFDS item code 201903207 · 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This product's status changed to Approval withdrawn on 2024.02.02.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 opioid-induced constipation
Who takes it
Adults
Adult dose
This medication should be taken orally, twice a day, with food and water. It should be swallowed whole and not divided or chewed. The need for maintenance therapy should be evaluated regularly. 1. Adults Chronic idiopathic constipation and opioid-induced constipation: The recommended dose is 24 mcg twice daily. For patients with moderate hepatic impairment (Child-Pugh Class B), treatment should begin with 16 mcg twice daily.

Ingredients

Importer
제일약품(주)

Efficacy & effects

Treatment of chronic idiopathic constipation and opioid-induced constipation

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

This medication is used to treat chronic idiopathic constipation in adults. Additionally, it helps alleviate constipation caused by opioid analgesics in adult patients taking them for chronic non-cancer pain. However, please note that its effectiveness in patients on certain opioid analgesics, such as methadone, has not yet been established. Overall, it is used to improve constipation symptoms and enhance the quality of life for patients.

How to take

Adult dose

This medication should be taken orally, twice a day, with food and water. It should be swallowed whole and not divided or chewed. The need for maintenance therapy should be evaluated regularly. 1. Adults Chronic idiopathic constipation and opioid-induced constipation: The recommended dose is 24 mcg twice daily. For patients with moderate hepatic impairment (Child-Pugh Class B), treatment should begin with 16 mcg twice daily.

Precautions

This medication should not be used in certain patients. For example, it should not be taken by those allergic to any components of this drug, those with intestinal obstruction or suspected obstruction, and women who are pregnant or may become pregnant. Patients with moderate to severe liver dysfunction and those with severely impaired renal function should use this medication with caution. Various side effects may occur while taking this medication. The most common side effects include nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas. Nausea and diarrhea, in particular, have been reported in many patients, and in severe cases, treatment may need to be discontinued. Furthermore, dizziness or hypotension may occur during the use of this medication, so caution is needed. These symptoms generally appear shortly after starting the medication or within the first hour after taking it. Difficulties in breathing may also occur, so if there are symptoms making breathing hard, immediate consultation with healthcare professionals is necessary. A thorough examination is required to ensure there is no intestinal obstruction before administering this medication to patients with intestinal obstruction. Taking this medication with food might help alleviate nausea symptoms. If severe diarrhea occurs, medication should be stopped immediately, and consultation with healthcare professionals is advised. Women who are pregnant or may become pregnant should not take this medication, and nursing mothers are also advised to avoid it. The safety and efficacy of this medication in children under 18 years old have not been established, so it should not be used. In cases of overdose, side effects such as vomiting, diarrhea, and abdominal pain may worsen, so it is essential to adhere to the prescribed dosage. Store this medication out of reach of children, avoid exposure to light and extreme temperatures, and do not move it to another container. The effects on driving or operating machinery are not known, but caution is advised due to potential dizziness from side effects. Also, since there may be interaction possibilities with certain opioid analgesics, healthcare professionals should be informed if those medications are also being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urinary issues

Mild side effects

Nausea, diarrhea, headache, abdominal pain, abdominal distension, bloating, vomiting, loose stools, abdominal discomfort, dyspepsia, thirst, dizziness, swelling, fatigue, chest discomfort/pain, peripheral edema, hematological and lymphatic system abnormalities (eosinophilia, neutropenia), decreased appetite, decreased potassium in the blood, fecal incontinence, muscle cramps, urgency of defecation, frequent bowel movements, sweating, throat pain, bowel dysfunction, anxiety, cold sweats, taste disturbances, belching,

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 or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oval soft capsule containing a transparent content

Package unit

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