Dosing & Uses
Dosage Forms & Strengths
Chronic Idiopathic Constipation
24 mcg PO q12hr
Irritable Bowel Syndrome With Constipation
Treatment in women ≥18 years
8 mcg PO q12hr
Treatment in patients with chronic noncancer pain
24 mcg PO q12hr
Effectiveness in patients taking diphenylheptane opioids (eg, methadone) has not been established
- Mild: Dose adjustment not necessary
- Moderate (Child-Pugh B): Chronic idiopathic or opioid-induced constipation, 16 mcg PO q12hr; irritable bowel syndrome with constipation (IBS-C), no dosage adjustment required
- Severe (Child-Pugh C): Chronic idiopathic or opioid-induced constipation, 8 mcg PO q12hr; IBS-C, 8 mcg PO q24hr
- If starting dose is tolerated and adequate response has not been obtained after appropriate interval, dose can be escalated to full standard dose with appropriate monitoring of patient response
Administer with food and water
Safety and efficacy not established
Chest discomfort (2%)
Peripheral edema (1-3%)
Abdominal distress (3%)
Abdominal pain (4-8%)
Loose stools (3%)
Increased heart rate
Muscle cramps or spasms
Frequent bowel movement
Loss of consciousness
Mechanical GI obstruction
Potential for mechanical GI obstruction
Potential for acute dyspnea; instruct patients to contact healthcare provider if dyspnea occurs
Avoid in severe diarrhea
May cause nausea and diarrhea (taking with food reduces chance of nausea); dose adjustment recommended
Patients with moderate-to-severe hepatic impairment (Child-Pugh class b or C) have higher systemic drug exposure
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 & Lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in breast milk; because lubiprostone increases fluid secretion in the intestine and intestinal motility, monitor breastfeeding infants for diarrhea
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Locally acting chloride channel activator; increases intestinal fluid secretion and intestinal motility; acts locally at apical portion of intestine
Low systemic absorption
Peak plasma time: 1 hr
Protein binding: 94% in vitro (may be irrelevant because of low systemic absorption)
Probably metabolized in stomach and jejunum by carbonyl anhydrase
Half-life: 0.9-1.4 hr
Excretion: Urine (60%), feces (trace amounts)
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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