Can Amitiza (Lubiprostone) Be Taken on an Empty Stomach?
No, Amitiza (lubiprostone) should be taken with food and water, not on an empty stomach. This administration requirement is explicitly stated in the FDA labeling and is critical for reducing the most common adverse effect—nausea.
FDA-Approved Administration Instructions
The FDA prescribing information for lubiprostone provides clear guidance 1:
- Take lubiprostone orally with food and water
- Swallow capsules whole; do not break apart or chew
- This applies to all approved indications (chronic idiopathic constipation, opioid-induced constipation, and IBS-C)
Clinical Rationale for Taking With Food
Nausea Reduction
Concomitant administration of food with lubiprostone significantly reduces symptoms of nausea, which is the most common adverse effect reported in clinical trials 1. The FDA labeling specifically warns that patients taking lubiprostone may experience nausea and recommends food co-administration as a mitigation strategy 1.
Evidence from Clinical Studies
Research has demonstrated that:
- Nausea occurs in approximately 35% of individuals taking lubiprostone 2
- The risk of nausea is dose-dependent and appears to be lower when taken with food and water 2
- Taking lubiprostone with food helps reduce gastrointestinal symptoms without compromising efficacy 3
Dosing Recommendations by Indication
The standard dosing regimens all specify administration with food 1:
- Chronic idiopathic constipation: 24 mcg twice daily with food
- Opioid-induced constipation: 24 mcg twice daily with food
- IBS-C in women: 8 mcg twice daily with food
Common Pitfall to Avoid
Do not advise patients to take lubiprostone on an empty stomach in an attempt to enhance absorption or speed onset of action. Lubiprostone acts locally within the intestinal tract with very low systemic bioavailability 4, so food does not interfere with its mechanism of action. The primary benefit of food co-administration is tolerability, not absorption 2.
Additional Safety Considerations
If nausea persists despite taking with food 1:
- Consider dose reduction in patients with hepatic impairment
- Evaluate whether the patient is swallowing capsules whole (breaking or chewing increases GI symptoms)
- Assess for severe diarrhea, which warrants discontinuation 1
Research suggests that domperidone may help manage lubiprostone-induced gastrointestinal symptoms, though this effect appears unrelated to gastric motility changes 3.