Lubiprostone

What it is and how it works

Mechanism class: Chloride Channel Activators

Indications

1. INDICATIONS AND USAGE Lubiprostone capsules is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. o Limitations of Use: Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. (1.2, 7.1) irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old. Chronic Idiopathic Constipation in Adults Lubiprostone capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Dosage and administration (summary)

2. DOSAGE AND ADMINISTRATION Recommended Dosage CIC and OIC: 24 mcg twice daily. IBS-C: 8 mcg twice daily. See full prescribing information for dosage adjustment by indication and degree of hepatic impairment. Administration Instructions Swallow capsules whole and do not break apart or chew, Take capsules with food and water, Assess periodically the need for continuous therapy. Recommended Dosage The recommended oral dosage of lubiprostone capsules by indication and adjustments for patients with moderate (Child Pugh Class B) and severe (Child Pugh Class C) hepatic impairment are shown in Table 1. Table-1 Administration Instructions Take lubiprostone capsules orally with food and water.

Contraindications

4. CONTRAINDICATIONS Lubiprostone capsules are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction . Patients with known or suspected mechanical gastrointestinal obstruction. (4, 5.5)

Warnings and precautions

5. WARNINGS AND PRECAUTIONS Nausea : Patients may experience nausea; concomitant administration of food may reduce this symptom. (2.2, 5.1) Diarrhea : Avoid use in patients with severe diarrhea. Instruct patients to discontinue lubiprostone capsules and contact their healthcare provider if severe diarrhea occurs during treatment. Syncope and Hypotension : May occur after taking the first dose or with subsequent doses. Generally resolves prior to the next dose, but may recur with repeat dosing.

Storage and supply

16. HOW SUPPLIED/STORAGE AND HANDLING Lubiprostone capsules are available as: The 8 mcg lubiprostone capsules are light orange oval capsules containing clear liquid printed with '8' with black ink.

Source: Lubiprostone (Lubiprostone) — US FDA prescribing information, 2025-06-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.