LUBIPROSTONE

14.1 Chronic Idiopathic Constipation in Adults Two double-blinded, placebo-controlled studies of identical design were conducted in patients with CIC. CIC was defined as, on average, less than 3 SBMs per week (a SBM is a bowel movement occurring in the absence of laxative use) along with one or more of the following symptoms of constipation for at least 6 months prior to randomization: 1) very hard stools for at least a quarter of all bowel movements; 2) sensation of incomplete evacuation following at least a quarter of all bowel movements; and 3) straining with defecation at least a quarter o...

The following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1)] Diarrhea [see Warnings and Precautions (5.2)] Syncope and Hypotension [see Warnings and Precautions (5.3)] Dyspnea [see Warnings and Precautions (5.4)] Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence. (6.1) OIC: nausea and diarrhea. (6.1) IBS-C: nausea, diarrhea, and abdominal pain. (6.1) To repo...

Lubiprostone capsules are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5)]. Patients with known or suspected mechanical gastrointestinal obstruction. (4, 5.5)

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. (5.2) 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. Instruct patients to di...

7 DRUG INTERACTIONS 7.1 Methadone Diphenylheptane opioids (e.g., methadone) have been shown in nonclinical studies to dose-dependently reduce the activation of ClC-2 by lubiprostone in the gastrointestinal tract. There is a possibility of a dose-dependent decrease in the efficacy of lubiprostone in patients using diphenylheptane opioids. No in vivo interaction studies have been conducted. The effe...