Lubiprostone 24mcg Capsules
It is used to treat constipation.It is used to treat irritable bowel syndrome with constipation (IBS-C).
Drug Class
Chloride channel activator
Pharmacologic Class
Prostone
Pregnancy Category
Category C
FDA Approved
Jan 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lubiprostone is a medication used to treat certain types of chronic constipation. It works by increasing the amount of fluid in your intestines, which helps to soften your stool and make it easier to have a bowel movement.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food and a full glass of water.
Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food and a full glass of water.
Swallow the medication whole - do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take with food and water to reduce the risk of nausea.
- Maintain adequate hydration throughout the day.
- Incorporate dietary fiber (fruits, vegetables, whole grains) as tolerated.
- Engage in regular physical activity to promote bowel regularity.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Chronic Idiopathic Constipation (CIC) and Opioid-Induced Constipation (OIC): 24 mcg orally twice daily. Irritable Bowel Syndrome with Constipation (IBS-C): 8 mcg orally twice daily.
Dose Range:
8 - 24 mg
Condition-Specific Dosing:
Chronic Idiopathic Constipation (CIC):
24 mcg orally twice daily
Opioid-Induced Constipation (OIC):
24 mcg orally twice daily
Irritable Bowel Syndrome with Constipation (IBS-C):
8 mcg orally twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended, but caution advised due to limited data.
Dialysis:
No specific dose adjustment recommended, but caution advised due to limited data.
Hepatic Impairment:
Mild:
No dose adjustment needed for CIC or OIC. For IBS-C, consider starting at 8 mcg once daily.
Moderate:
For CIC and OIC, reduce dose to 16 mcg orally twice daily. For IBS-C, reduce dose to 8 mcg once daily.
Severe:
For CIC and OIC, reduce dose to 8 mcg orally twice daily. For IBS-C, reduce dose to 8 mcg once daily.
Pharmacology
Mechanism of Action
Lubiprostone is a bicyclic fatty acid derivative that acts locally in the gastrointestinal tract to activate ClC-2 chloride channels on the apical membrane of gastrointestinal epithelial cells. This activation increases intestinal fluid secretion, which in turn softens the stool and increases motility, facilitating spontaneous bowel movements.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Administration with food decreases the incidence of nausea.
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 0.9-1.4 hours (for M-3, the active metabolite, after oral administration)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily via feces (approximately 60% as metabolites) and urine (approximately 10% as metabolites).
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 24 hours for initial bowel movement in some patients, but full effect may take longer.
PeakEffect:
Not well-defined due to local action and minimal systemic absorption.
DurationOfAction:
Not well-defined due to local action and minimal systemic absorption; typically dosed twice daily.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Low blood pressure, which can lead to hospitalization. You are more likely to experience low blood pressure if you have diarrhea or vomiting. If you feel extremely dizzy or lightheaded, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain or diarrhea
Gas
Bloating
Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Low blood pressure, which can lead to hospitalization. You are more likely to experience low blood pressure if you have diarrhea or vomiting. If you feel extremely dizzy or lightheaded, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain or diarrhea
Gas
Bloating
Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea
- Severe abdominal pain or cramping
- Difficulty breathing or shortness of breath (dyspnea) that is severe or does not resolve
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Diarrhea
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Diarrhea
This list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Severe nausea
- Vomiting
- Abdominal pain
What to Do:
There is no specific antidote for lubiprostone overdose. Treatment should be symptomatic and supportive. Discontinue the medication and contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of constipation type (CIC, IBS-C, OIC)
Rationale: To ensure appropriate indication and dosing.
Timing: Prior to initiation of therapy
Assessment of baseline bowel habits (frequency, consistency, straining)
Rationale: To establish a baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy
Renal and hepatic function
Rationale: To determine if dose adjustments are necessary for hepatic impairment; caution in severe renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Bowel movement frequency and consistency
Frequency: Regularly during treatment
Target: Increased frequency, softer stools, reduced straining
Action Threshold: Lack of improvement after several weeks, or worsening symptoms, may indicate need for re-evaluation.
Adverse effects (e.g., nausea, diarrhea, abdominal pain, dyspnea)
Frequency: Regularly, especially during initial treatment
Target: Absence or mild, tolerable symptoms
Action Threshold: Persistent or severe nausea, diarrhea, or dyspnea may require dose reduction or discontinuation.
Symptom Monitoring
- Nausea (common, can be reduced by taking with food)
- Diarrhea
- Abdominal pain/distension
- Flatulence
- Headache
- Dyspnea (rare, transient, usually resolves within hours)
Special Patient Groups
Pregnancy
Lubiprostone is Pregnancy Category C. Animal studies have shown adverse effects on the fetus at doses higher than human therapeutic doses. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; human data limited.
Second Trimester:
Potential risk based on animal data; human data limited.
Third Trimester:
Potential risk based on animal data; human data limited.
Lactation
It is unknown whether lubiprostone or its metabolites are excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for lubiprostone and any potential adverse effects on the breastfed infant from lubiprostone or from the underlying maternal condition.
Infant Risk:
Low risk (L3) due to minimal systemic absorption, but caution advised.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in patients under 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age alone.
Clinical Information
Clinical Pearls
- Always take lubiprostone with food and water to minimize the risk of nausea.
- Transient dyspnea (shortness of breath) can occur, usually within an hour of the first dose, and typically resolves within a few hours. Patients should be advised of this potential side effect.
- Lubiprostone is not a laxative and works differently; it increases fluid secretion rather than directly stimulating muscle contractions.
- Patients should be evaluated for mechanical obstruction prior to initiating lubiprostone therapy.
- For IBS-C, the lower 8 mcg BID dose is used, while for CIC and OIC, the 24 mcg BID dose is used.
Alternative Therapies
- Linaclotide (Linzess)
- Plecanatide (Trulance)
- Tenapanor (Ibsrela)
- Prucalopride (Motegrity)
- Naloxegol (Movantik)
- Methylnaltrexone (Relistor)
- Naldemedine (Symproic)
- Polyethylene glycol (MiraLAX)
- Lactulose
- Magnesium hydroxide
- Fiber supplements
Cost & Coverage
Average Cost:
Varies widely, typically $300-$500+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.