Lubiprostone Capsule
Product Images NDC 72603-288

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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 72603-288). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx Llc, 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 text contains information about a medication called Lubiprostone, which comes in the form of 60 soft gel capsules. Each capsule contains 24 mg of Lubiprostone. The instructions emphasize swallowing the capsules whole without breaking or chewing them. It is recommended to keep the capsules in a tightly closed, light-resistant container and store them at a temperature range of 20° to 25°C (68° to 77°F). The medication is manufactured for Northstar R LLC in Memphis, TN, and produced by Ascent Pharmaceuticals, Inc. in Central Islip, NY. Additionally, it is noted to protect the capsules from extreme temperatures and to keep the container tightly closed. For more detailed prescribing information, reference should be made to the package insert.*
FDA Label Image

8mcg-60s (8mcg 60s)

8mcg-60s (8mcg 60s)
This text provides information about the medication Lubiprostone, which is in the form of capsules. It is advised to swallow the capsules whole and not to break them apart or chew them. Each capsule contains 8 mg of Lubiprostone. It should be stored at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). The medication is dispensed in a tightly closed, light-resistant container to protect it from extreme temperatures. The manufacturing details indicate it is made for Northstar LLC in Memphis and manufactured by Ascent Pharmaceuticals in Central Islip, NY.*
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Structure (Structure)

Structure (Structure)
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
This is a list of adverse reactions reported in clinical trials of adults with Chronic Idiopathic Constipation (CIC) who were treated with either a placebo or Lubiprostone capsules. The table includes the percentage of patients experiencing each adverse reaction. The adverse reactions reported with Lubiprostone capsules and greater than placebo 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 table specifies that these reactions were reported in at least 1% of patients treated with Lubiprostone capsules.*
FDA Label Image

Table-1 (Table 1)

Table-1 (Table 1)
Recommended Dosage Regimen for CIC and 0IC 1BS-C includes 24 mcg twice daily for adults, or 8 mcg twice daily. Adjustments are necessary for patients with moderate and severe hepatic impairment (Child-Pugh Class B or C). If the initial dose is tolerated and there is no adequate response, doses can be escalated to full dosing with careful patient monitoring.*
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Table-3 (Table 3)

Table-3 (Table 3)
This is a table displaying the adverse reactions noted in clinical trials comparing Lubiprostone to a placebo in adults with OIC (opioid-induced constipation). The table lists different adverse reactions along with the percentage of occurrence in patients. Adverse reactions include nausea, diarrhea, abdominal pain, flatulence, abdominal distension, vomiting, headache, peripheral edema, and abdominal discomfort. It is noteworthy that abdominal discomfort reported is at least 1% of patients treated with Lubiprostone capsules and greater than the placebo.*
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Table-4 (Table 4)

Table-4 (Table 4)
This text provides a table showing the adverse reactions reported in clinical trials of adults with IBS-C who were treated with Lubiprostone capsules. The table lists the adverse reactions including nausea, diarrhea, abdominal pain, and abdominal distension, along with the percentages of these reactions in patients treated with either a placebo or the capsules. Adverse reactions that were reported in at least 1% of patients treated with Lubiprostone capsules and were greater than the placebo are included in the table.*
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Table-5 (Table 5)

Table-5 (Table 5)
This text presents a table showing the pharmacokinetic parameters of the metabolite M3 for subjects with normal or impaired liver function after being administered Lubiprostone. The data includes mean (SD) values and percentage changes in area under the curve (AuC) compared to normal liver function subjects. Results are provided for individuals with normal liver function, Child-Pugh Class B, and Child-Pugh Class C. The table indicates how the metabolite M3 levels change with varying liver function statuses.*
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Table-6 (Table 6)

Table-6 (Table 6)
This is a table showing Adult Spontaneous Bowel Movement Frequency Rates from Efficacy Studies over several weeks, tracking changes from the Baseline. It includes data on the mean and median values for each week, with comparisons between Placebo and Lubiprostone Capsules. The frequency rates are calculated based on the number of Spontaneous Bowel Movements over the observed days in a given week.*

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