Lubiprostone Capsule
Product Images NDC 31722-404

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Lubiprostone (NDC 31722-404). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber Pharmaceuticals, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

24mcg-60s (24mcg 60s)

24mcg-60s (24mcg 60s)
This is a label for Lubiprostone Capsules, with instructions on how to use the medication, its storage conditions, dosage information, and details about the manufacturer. It is essential to swallow the capsules whole, not break apart or chew them. Each soft gel capsule contains 24 mg of Lubiprostone. The medication should be dispensed in a tightly closed, light-resistant container and stored at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). The container should be kept tightly closed and protected from extreme temperatures. The medication is manufactured by Ascent Pharmaceuticals, Inc. in Central Islip, NY, and manufactured for Camber Pharmaceuticals, Inc. in Piscataway, NJ.*
FDA Label Image

8mcg-60s (8mcg 60s)

8mcg-60s (8mcg 60s)
This text is a label for Lubiprostone capsules, indicating that they should be swallowed whole without breaking apart or chewing. Each soft gel capsule contains 8 mg of Lubiprostone. The medication should be dispensed in a tightly closed, light-resistant container and stored at a temperature of 20° to 25°C with excursions permitted between 15° to 30°C. It is manufactured by Ascent Pharmaceuticals, Inc. for Camber Pharmaceuticals, Inc. The label also advises keeping the medication out of reach of children and protected from extreme temperatures.*
FDA Label Image

Structure (Structure)

Structure (Structure)
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
This is a table showing the adverse reactions reported in clinical trials of adults with Chronic Idiopathic Constipation (CIC) for both a placebo group and a group receiving Lubiprostone capsules. The adverse reactions reported include nausea, diarrhea, headache, abdominal pain, abdominal distension, flatulence, vomiting, loose stools, edema, abdominal discomfort, dizziness, chest discomfort/pain, dyspnea, dyspepsia, fatigue, and dry mouth. The percentages of patients experiencing each reaction are also included in the table.*
FDA Label Image

Table-1 (Table 1)

Table-1 (Table 1)
This is a recommendation for the dosage regimen of a medication called CIC and OIC 1BS-C for adults with or without hepatic impairment. The recommended adult dosage is 24 micrograms twice daily or 8 micrograms twice daily. There are specific dosage adjustments for individuals with moderate or severe hepatic impairment (Child-Pugh Class B or C). If the initial dose is well-tolerated but not effective, doses can be escalated to full dosing while monitoring the patient's response.*
FDA Label Image

Table-3 (Table 3)

Table-3 (Table 3)
This is a summary of adverse reactions observed in clinical trials of adults taking lubiprostone compared to a placebo. Common side effects reported for lubiprostone include nausea, diarrhea, abdominal pain, flatulence, abdominal distension, vomiting, headache, peripheral edema, and abdominal discomfort. It is noted that abdominal discomfort was reported in at least 1% of patients treated with lubiprostone capsules and was greater than the placebo group. The term "abdominal discomfort" is a combination of several related symptoms such as abdominal tenderness, abdominal rigidity, gastrointestinal discomfort, stomach discomfort, and abdominal discomfort itself.*
FDA Label Image

Table-4 (Table 4)

Table-4 (Table 4)
This text provides a table detailing the adverse reactions observed in clinical trials of adults with IBS-C who were treated with lubiprostone capsules compared to a placebo. The table lists the percentage of patients experiencing nausea, diarrhea, abdominal pain, and abdominal distension. Adverse reactions reported in at least 1% of patients treated with lubiprostone capsules and at a higher rate than with the placebo include nausea, diarrhea, and abdominal distension.*
FDA Label Image

Table-5 (Table 5)

Table-5 (Table 5)
Table 5 presents the pharmacokinetic parameters of the Metabolite M3 following dosing with Lubiprostone in subjects with normal or impaired liver function. The data includes the mean (standard deviation) values and percentage changes in area under the curve (AUC) and clearance (Cl) compared to normal liver function. The table shows results for subjects with normal liver function (n=8), Child-Pugh Class B (n=8), and Child-Pugh Class C (n=8). The data indicates significant differences in AUC and Cl values across the different liver function statuses.*
FDA Label Image

Table-6 (Table 6)

Table-6 (Table 6)
This is a table showing Adult Spontaneous Bowel Movement Frequency Rates from efficacy studies. The table displays data for baseline and Weeks 1-4, along with mean and median values for each time point. The Study involves Placebo and Lubiprostone Capsules given twice daily. The table includes numbers representing the frequency rates of SBMs calculated based on the number of bowel movements and days observed for each week.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.