Classes
DEA Class; Rx
Common Brand Names; Amitiza
- IBS Agents;
- Laxatives, Other
Description
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
Indications
Contraindications
Hypersensitivity
Mechanical GI obstruction
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Lubiprostone
capsule
- 8mcg
- 24mcg