Skip to content

Lubiprostone

    DEA Class; Rx

    Common Brand Names; Amitiza

    • IBS Agents; 
    • Laxatives, Other

    Chloride channel (CIC-2) activator
    Used to treat adults with chronic idiopathic constipation or opiate agonist-induced constipation (OIC), and in adult women with constipation-predominant irritable bowel syndrome (IBS-C)
    Most common side effect is nausea

    Indicated for the treatment of chronic idiopathic constipation (e.g., 6 month or longer history of less than 3 spontaneous bowel movements per week, with at least 25% of bowel movements with hard stools, sensation of incomplete evacuation, or straining).
    Indicated for treatment of chronic idiopathic constipation (CIC) in adultsIndicated for treatment of irritable bowel syndrome with constipation (IBS-C) in women aged ≥18 yearsIndicated for treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation

    Hypersensitivity

    Mechanical GI obstruction

    • Nausea (8-29%)
    • Diarrhea (7-12%)
    • Headache (2-11%)
    • Abdominal pain (4-8%)
    • Abdominal distension (3-6%)
    • Flatulence (4-6%)
    • Vomiting (3%)
    • Loose stools (3%)
    • Edema (1-3%)
    • Abdominal discomfort (1-3%)
    • Dizziness (3%)
    • Chest discomfort/pain (2%)
    • Dyspnea (2%)
    • Dyspepsia (2%)
    • Fatigue (2%)
    • Dry mouth (1%)

    In patients with symptoms suggestive of mechanical GI obstruction, perform a thorough evaluation to confirm the absence of an obstruction prior to initiating therapy (see Contraindications)

    Potential for acute dyspnea described as sensation of chest tightness and difficulty breathing within 30-60 minutes after the first dose; instruct patients to contact healthcare provider if dyspnea occurs

    Avoid use in patients with severe diarrhea; instruct patients of potential for diarrhea to occur during treatment

    May cause nausea and diarrhea (taking with food reduces chance of nausea); dose adjustment recommended

    Syncope and hypotension reported, some of which required hospitalization; most cases occurred in patients taking 24 mcg twice daily and some occurred within hour after taking first dose or subsequent doses; patients should be aware of risk of syncope and hypotension during treatment and other adverse reactions, such as diarrhea or vomiting may increase this risk

    Following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, M3, has measurable systemic concentrations

    No data are available on the presence in human milk of the refect on milk production

    Adults

    Females: 48 mcg/day PO for chronic idiopathic constipation and opiate agonist-induced constipation; 16 mcg/day PO for irritable bowel syndrome.
    Males: 48 mcg/day PO for chronic idiopathic constipation and opiate agonist-induced constipation; safety and efficacy have not been established for irritable bowel syndrome.

    Geriatric

    Females: 48 mcg/day PO for chronic idiopathic constipation and opiate agonist-induced constipation; 16 mcg/day PO for irritable bowel syndrome.
    Males: 48 mcg/day PO for chronic idiopathic constipation and opiate agonist-induced constipation; safety and efficacy have not been established for irritable bowel syndrome.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Neonates

    Not indicated.

    Lubiprostone 

    capsule

    • 8mcg
    • 24mcg