LUBIPROSTONE Drug Interactions: What You Need to Know

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 effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylhepatane opioids (e.g., methadone) has not been established <span class="opacity-50 text-xs">[see Indications and Usage (1.2)]</span>.

4.

Contraindications

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)

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. (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 discontinue lubiprostone capsules and contact their healthcare provider if symptoms occur. (5.3) Dyspnea : May occur within an hour of first dose. Generally resolves within 3 hours, but may recur with repeat dosing. Instruct patients to contact their healthcare provider if symptoms occur. (5.4)

Bowel

Obstruction : Evaluate patients with symptoms suggestive of mechanical gastrointestinal obstruction prior to initiating treatment with lubiprostone capsules. (4, 5.5)

5.1 Nausea Patients taking lubiprostone capsules may experience nausea. Concomitant administration of food with lubiprostone capsules may reduce symptoms of nausea <span class="opacity-50 text-xs">[see Adverse Reactions (6.1)]</span>.

5.2 Diarrhea Avoid use of lubiprostone capsules in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue lubiprostone capsules and contact their healthcare provider if severe diarrhea occurs <span class="opacity-50 text-xs">[see Adverse Reactions (6.1)]</span>.

5.3 Syncope and Hypotension Syncope and hypotension have been reported with lubiprostone in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most cases occurred in patients taking 24 mcg twice daily and some occurred within an hour after taking the first dose or subsequent doses of lubiprostone capsules. Some patients had concomitant diarrhea or vomiting prior to developing the adverse reaction. Syncope and hypotension generally resolved following lubiprostone discontinuation or prior to next dose, but recurrence has been reported with subsequent doses. Several cases reported concomitant use of medications known to lower blood pressure, which may increase the risk for the development of syncope or hypotension. Patients should be aware of the risk of syncope and hypotension during treatment and that other adverse reactions may increase this risk, such as diarrhea or vomiting.

5.4 Dyspnea In clinical trials, dyspnea was reported by 3%, 1%, and &lt;1% of the treated CIC, OIC, and IBS-C populations receiving lubiprostone capsules, respectively, compared to 0%, 1%, and &lt;1% of placebo-treated patients. There have been postmarketing reports of dyspnea when using lubiprostone capsules 24 mcg twice daily. Some patients have discontinued treatment because of dyspnea. These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30 to 60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses. Instruct patients to contact their healthcare provider if dyspnea occurs.

5.5 Bowel Obstruction In patients with symptoms suggestive of mechanical gastrointestinal obstruction, perform a thorough evaluation to confirm the absence of an obstruction prior to initiating therapy with lubiprostone capsules <span class="opacity-50 text-xs">[see Contraindications (4)]</span>.