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Lubiprostone

Lubiconst · ATC code A06AX03

Also known as: Lubiproston

Key facts
Active substance
Lubiprostone
ATC code
A06AX03
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Lubiprostone activates chloride channels (ClC-2) in the gastrointestinal tract and is used, per the US prescribing information, for chronic idiopathic constipation, opioid-induced constipation and IBS with constipation.

What it is used for

  • Chronic idiopathic constipation (CIC) in adults.
  • Opioid-induced constipation (OIC) in adults with chronic non-cancer pain; effectiveness with diphenylheptane opioids such as methadone has not been established.
  • Irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.

Dosing

  • CIC and OIC: 24 mcg twice daily; IBS-C: 8 mcg twice daily.
  • Moderate hepatic impairment (Child-Pugh Class B): CIC/OIC 16 mcg twice daily, IBS-C no adjustment.
  • Severe hepatic impairment (Child-Pugh Class C): CIC/OIC 8 mcg twice daily, IBS-C 8 mcg once daily.
  • Take with food and water; swallow capsules whole; periodically assess the need for continued therapy.

Contraindications

  • Known or suspected mechanical gastrointestinal obstruction.

Important warnings

  • Nausea is common; taking it with food may reduce nausea.
  • Avoid in severe diarrhea and stop if severe diarrhea occurs.
  • Syncope and hypotension reported after marketing, mostly with 24 mcg twice daily, some within an hour of a dose.
  • Dyspnea with chest tightness, generally with acute onset 30 to 60 minutes after the first dose.
  • Evaluate thoroughly for mechanical obstruction before starting if symptoms suggest it.

Side effects

  • Most common in CIC: nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distension and flatulence (6% each).
  • Others: vomiting, loose stools, edema, dizziness, chest discomfort, dyspnea.
  • Postmarketing: syncope, hypotension, tachycardia, ischemic colitis, hypersensitivity reactions, muscle cramps.

Interactions

  • Diphenylheptane opioids (e.g. methadone) may dose-dependently reduce lubiprostone's efficacy.

Pregnancy and breastfeeding

  • Limited data in pregnant women are insufficient to assess risk; for animal data see the full text.
  • Monitor breastfed infants for diarrhea.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Turkey

  • LubiconstSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AmitizaSpecGx LLC, Takeda Pharmaceuticals America, Inc. · 2 register entries
  • Amitza1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Lubiprostone (Sun Pharmaceutical Industries, Inc.) – Prescribing Information, 2026-07-14. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f06d76d2-028a-629f-e053-2995a90a80f5
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.