Lubiprostone

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.
• 2.1 Recommended Dosage The recommended oral dosage of Lubiprostone by indication and adjustments for patients with moderate (Child Pugh Class B) and severe (Child Pugh Class C) hepatic impairment are shown in Table 1.
• Table 1.
• Recommended Dosage Regimen CIC and OIC IBS-C Recommended Adult Dosage Regimen 24 mcg twice daily 8 mcg twice daily Dosage Adjustment for Hepatic Impairment [see Use in Specific Populations (8.6) ] Moderate Impairment (Child-Pugh Class B) :
• 16 mcg twice daily If the dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response.
• Moderate Impairment (Child-Pugh Class B) :
• No adjustment necessary Severe Impairment (Child-Pugh Class C) :
• 8 mcg twice daily Severe Impairment (Child-Pugh Class C) :
• 8 mcg once daily
• 2.2 Administration Instructions Take lubiprostone orally with food and water.
• Swallow capsules whole and do not break apart or chew.
• Physicians and patients should periodically assess the need for continued therapy.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Safety and effectiveness have not been established in pediatric patients with IBS-C, pediatric functional constipation (PFC), and OIC.
• Efficacy was not demonstrated for the treatment of PFC in patients 6 years of age and older in a 12 week, randomized, double-blind, placebo-controlled trial conducted in 606 patients 6 to 17 years with PFC comparing lubiprostone to placebo.
• The primary efficacy endpoint was an overall response based on spontaneous bowel movement frequency over the duration of the trial; the treatment difference from placebo was not statistically significant.
• In this age group, adverse reactions to lubiprostone were similar to those reported in
• adults.
• In a 36-week, long-term safety extension trial after approximately 9 months of treatment with lubiprostone, a single case of reversible elevation of ALT (17-times upper limit of normal [ULN]), AST (13-times ULN), and GGT (9-times [ULN]) was observed in a child with baseline elevated values (less than or equal to 2.5-times ULN).
• Juvenile Animal Toxicity Data In a 13-week oral toxicity study in juvenile rats, a significant decrease in total bone mineral density was observed in female pups at 0.5 mg/kg/day; in male pups, a significantly lower cortical thickness at the tibial diaphysis was observed at 0.5 mg/kg.
• The 0.5 mg/kg/day dose is approximately 101 times the maximum recommended adult dose of 48 mcg/day, based on body surface area (mg/m 2 ).

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Chronic Idiopathic Constipation The efficacy of lubiprostone 24 mcg twice daily in the elderly (at least 65 years of age) subpopulation with CIC was consistent with the efficacy in the overall study population.
• Of the total number of patients treated in the dose-finding, efficacy, and long-term studies of lubiprostone, 16% were at least 65 years of age, and 4% were at least 75 years of age.
• Elderly patients taking lubiprostone experienced a lower rate of associated nausea compared to the overall study population taking lubiprostone (19% vs. 29%, respectively).
• Opioid-Induced Constipation The safety profile of lubiprostone in the elderly (at least 65 years of age) subpopulation with OIC (9% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population.
• Clinical studies of lubiprostone did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.
• Irritable Bowel Syndrome with Constipation The safety profile of lubiprostone in the elderly (at least 65 years of age) subpopulation with IBS-C (8% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population.
• Clinical studies of lubiprostone did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.

Quoted from the official label, section “Geriatric Use”.

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.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
• During clinical development of lubiprostone for CIC, OIC, and IBS-C, 1648 patients were treated with lubiprostone for 6 months and 710 patients were treated for 1 year (not mutually exclusive).
• Chronic Idiopathic Constipation Adverse reactions in adult dose-finding, efficacy, and long-term clinical studies:
• The data described below reflect exposure to Lubiprostone 24 mcg twice daily in 1113 patients with CIC over 3- or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure (≤4 weeks).
• The placebo population (N = 316) had a mean age of 48 (range 21 to 81) years; was 87% female; 81% Caucasian, 10% African American, 7% Hispanic, 1% Asian, and 12% elderly (≥65 years of age).
• Of those patients treated with lubiprostone 24 mcg twice daily (N=1113), the mean age was 50 (range 19-86) years; 87% were female; 86% Caucasian, 8% African American, 5% Hispanic, 1% Asian, and 17% elderly (≥65 years of age).
• The most common adverse reactions (>4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.
• Table 2 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with Lubiprostone than placebo.
• Table 2.
• Adverse Reactions Reported in at least 1% of patients treated with Lubiprostone and greater than placebo in Clinical Trials of
• Adults with CIC System/Adverse Reaction Placebo Lubiprostone 24 mcg Twice Daily N = 316 % N = 1113 % Nausea 3 29 Diarrhea 1 12 Headache 5 11 Abdominal pain 3 8 Abdominal distension 2 6 Flatulence 2 6 Vomiting 0 3 Loose stools 0 3 Edema <1 3 Abdominal discomfort This term combines "abdominal tenderness," "abdominal rigidity," "gastrointestinal discomfort," "stomach discomfort", and "abdominal discomfort." 1 3 Dizziness 1 3 Chest discomfort/pain 0 2 Dyspnea 0 2 Dyspepsia <1 2 Fatigue 1 2 Dry mouth <1 1 Nausea:
• Approximately 29% of patients who received lubiprostone experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea.
• The rate of nausea was lower among male (8%) and elderly (19%) patients.
• No patients in the clinical studies were hospitalized due to nausea.
• Diarrhea:
• Approximately 12% of patients who received lubiprostone experienced diarrhea; 2% of patients had severe diarrhea and 2% of patients discontinued treatment due to diarrhea.
• Electrolytes:
• No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving lubiprostone.
• Less common adverse reactions (<1%):
• fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite.
• Opioid-Induced Constipation Adverse reactions in adult efficacy and long-term clinical studies:
• The data described below reflect exposure to lubiprostone 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks.
• The total population (N = 1492) had a mean age of 50 (range 20–89) years; was 63% female; 83% Caucasian, 14% African American, 1% American Indian/Alaska Native, 1% Asian; 5% were of Hispanic ethnicity, and 9% were elderly (≥65 years of age).
• The most common adverse reactions (>4%) in OIC were nausea and diarrhea.
• Table 3 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.
• Table 3.
• Adverse Reactions Reported in at least 1% of patients treated with Lubiprostone and greater than placebo in Clinical Trials of
• Adults with OIC System/Adverse Reaction Placebo Lubiprostone 24 mcg Twice Daily N = 632 % N = 860 % Nausea 5 11 Diarrhea 2 8 Abdominal pain 1 4 Flatulence 3 4 Abdominal distension 2 3 Vomiting 2 3 Headache 1 2 Peripheral edema <1 1 Abdominal discomfort This term combines "abdominal tenderness," "abdominal rigidity," "gastrointestinal discomfort," "stomach discomfort", and "abdominal discomfort." 1 1 Nausea:
• Approximately 11% of patients who received lubiprostone experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea.
• Diarrhea:
• Approximately 8% of patients who received lubiprostone experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea.
• Less common adverse reactions (<1%): fecal incontinence, blood potassium decreased.
• Irritable Bowel Syndrome with Constipation Adverse reactions in adult dose-finding, efficacy, and long-term clinical studies:
• The data described below reflect exposure to lubiprostone 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks.
• The total population (N = 1267) had a mean age of 47 (range 18–85) years; was 92% female; 78% Caucasian, 13% African American, 9% Hispanic, 0.4% Asian, and 8% elderly (≥65 years of age).
• The most common adverse reactions (>4%) in IBS-C were nausea, diarrhea, and abdominal pain.
• Table 4 presents data for the adverse reactions that occurred in at least 1% of patients and that occurred more frequently with study drug than placebo.
• Table 4.
• Adverse Reactions Reported in at least 1% of patients treated with lubiprostone and greater than placebo in Clinical Trials of
• Adults with IBS-C System/Adverse Reaction Placebo Lubiprostone 8 mcg Twice Daily N = 435 % N = 1011 % Nausea 4 8 Diarrhea 4 7 Abdominal pain 5 5 Abdominal distension 2 3 Nausea:
• Approximately 8% of patients who received lubiprostone 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea.
• Diarrhea:
• Approximately 7% of patients who received lubiprostone 8 mcg twice daily experienced diarrhea; <1% of patients had severe diarrhea and <1% of patients discontinued treatment due to diarrhea.
• Less common adverse reactions (<1%):
• dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria.
• 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of lubiprostone.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Cardiovascular:
• syncope and/or hypotension [see Warnings and Precautions (5.3) ] , tachycardia Gastrointestinal:
• ischemic colitis General:
• asthenia Immune System:
• hypersensitivity reactions including rash, swelling, and throat tightness malaise Muscoskeletal:
• muscle cramps or muscle spasms.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Administration Instructions Instruct patients to take lubiprostone orally with food and water to reduce the occurrence of nausea [see Warnings and Precautions (5.1) ] .
• Swallow capsules whole and do not break apart or chew.
• Physicians and patients should periodically assess the need for continued therapy.
• Diarrhea Inform patients that they may experience diarrhea during treatment with lubiprostone.
• Instruct patients to discontinue lubiprostone and contact their healthcare provider if severe diarrhea occurs [see Warnings and Precautions (5.2) ].
• Syncope and Hypotension Inform patients that they may experience syncope and hypotension after taking the first dose or subsequent doses of lubiprostone.
• Syncope and hypotension generally resolve prior to the next dose, but may recur with repeat dosing.
• Instruct patients to discontinue Lubiprostone and to contact their healthcare provider if these reactions occur [see Warnings and Precautions (5.3) ] .
• Inform patients that other adverse reactions may increase the risk of syncope and hypotension, such as diarrhea or vomiting.
• Dyspnea Inform patients that they may experience dyspnea within an hour of the first dose.
• Dyspnea generally resolves within 3 hours, but may recur with repeat dosing.
• Instruct patients to inform their healthcare provider if dyspnea occurs [see Warnings and Precautions (5.4) ] .
• Lactation Advise lactating women to monitor their human milk-fed infants for diarrhea while taking lubiprostone [ see Use in Specific Populations (8.2) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Lubiprostone is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone. 8 mcg capsules are pink and are printed with "SPI" on one side 24 mcg capsules are orange and are printed with "SPI" on one side Capsules:
• 8 mcg and 24 mcg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Lubiprostone is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with "SPI" printed on one side.
• Lubiprostone is available as follows:
• 8 mcg pink capsule Bottles of 30 (NDC 76420-906-30 repackaged from NDC 63304-351-XX) Bottles of 60 (NDC 76420-906-60 relabeled from NDC 63304-351-60) Bottles of 90 (NDC 76420-906-90 repackaged from NDC 63304-351-XX) Bottles of 100 (NDC 76420-906-01 repackaged from NDC 63304-351-XX) 24 mcg orange capsule Bottles of 30 (NDC 76420-907-30 repackaged from NDC 63304-352-XX) Bottles of 60 (NDC 76420-907-60 relabeled from NDC 63304-352-60) Bottles of 90 (NDC 76420-907-90 repackaged from NDC 63304-352-XX) Bottles of 100 (NDC 76420-907-01 repackaged from NDC 63304-352-XX)
• Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Protect from light and extreme temperatures.

Quoted from the official label, section “How Supplied”.

How to store it

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and extreme temperatures.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Lubiprostone is a chloride channel activator for oral use.
• The chemical name for lubiprostone is (–)-7-[(2 R ,4a R ,5 R ,7a R )-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ b ]pyran-5-yl]heptanoic acid.
• The molecular formula of lubiprostone is C 20 H 32 F 2 O 5 with a molecular weight of 390.46 and a chemical structure as follows:
• Lubiprostone drug substance occurs as white, odorless crystals or crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water.
• Lubiprostone is available as an imprinted, oval, soft gelatin capsule in two strengths.
• Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients:
• ferric oxide, gelatin, medium-chain triglycerides, purified water, sorbitol, and titanium dioxide.
• Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients:
• D&C Yellow #10, FD&C Red #40, gelatin, medium-chain triglycerides, purified water, and sorbitol.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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