Camber Pharmaceuticals, Inc.

Lubiprostone

Generic

ID: 31722040360

NaN

Reviews

📜 Prescription Required

FORM

Capsule

STRENGTH

.008 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

1. INDICATIONS AND USAGE SPL UNCLASSIFIED SECTION DOSAGE & ADMINISTRATION SECTION DOSAGE FORMS & STRENGTHS SECTION CONTRAINDICATIONS SECTION

🩺What it's for

Lubiprostone capsules is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. (1.1) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

💊How to take it

Recommended Dosage (2.1) CIC and OIC: 24 mcg twice daily. IBS-C: 8 mcg twice daily. See full prescribing information for dosage adjustment by indication and degree of hepatic impairment. Administration Instructions (2.2) Swallow capsules whole and do not break apart or chew, Take capsules with food and water, Assess periodically the need for continuous therapy.

ℹ️Common side effects

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.

⚠️Serious risks

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.

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Two double-blinded, placebo-controlled studies of similar design were conducted in adult patients with IBS-C. IBS was defined as abdominal pain or discomfort occurring over at least 6 months with two or more of the following: 1) relieved with defecation; 2) onset associated with a change in stool frequency; and 3) onset associated with a change in stool form. Patients were sub-typed as having IBS-C if they also experienced two of three of the following: 1) <3 spontaneous bowel movements (SBMs) per week, 2) >25% hard stools, and 3) >25% SBMs associated with straining. Following a 4-week baseline/washout period, a total of 1154 patients (mean age 47 [range 18 to 85] years; 92% female; 77% Caucasian, 13% African American, 9% Hispanic, 0.4% Asian; 8% at least 65 years of age) were randomized and received lubiprostone capsules 8 mcg twice daily (16 mcg/day) or placebo twice daily for 12 weeks. The primary efficacy endpoint was assessed weekly utilizing the patient s response to a global symptom relief question based on a 7-point, balanced scale ( significantly worse to significantly relieved ): How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared to how you felt before you entered the study? The primary efficacy analysis was a comparison of the proportion of overall responders in each arm. A patient was considered an overall responder if the criteria for being designated a monthly responder were met in at least 2 of the 3 months on study. A monthly responder was defined as a patient who had reported significantly relieved for at least 2 weeks of the month or at least moderately relieved in all 4 weeks of that month. During each monthly evaluation period, patients reporting moderately worse or significantly worse relief, an increase in rescue medication use, or those who discontinued due to lack of efficacy, were deemed non-responders. The percentage of patients in Study 1 qualifying as an overall responder was 14% in the group receiving lubiprostone capsules 8 mcg twice daily compared to 8% of patients receiving placebo twice daily. In Study 2, 12% of patients in the lubiprostone capsules 8 mcg group were overall responders versus 6% of patients in the placebo group. In both studies, the treatment differences between the placebo and lubiprostone groups were statistically significant. Results in men: The two randomized, placebo-controlled, double-blinded studies comprised 97 (8%) male patients, which is insufficient to determine whether men with IBS-C respond differently to lubiprostone capsules from women. During a 4-week randomized withdrawal period following Study 1, patients who received lubiprostone capsules during the 12-week treatment period were re-randomized to receive either placebo or to continue treatment with lubiprostone capsules. In lubiprostone-treated patients who were overall responders during Study 1 and who were re-randomized to placebo, SBM frequency rates did not result in worsening compared to baseline.