Lubiprostone 8mcg Capsules
It is used to treat constipation.It is used to treat irritable bowel syndrome with constipation (IBS-C).
Drug Class
Chloride Channel Activator; Laxative
Pharmacologic Class
Bicyclic Fatty Acid
Pregnancy Category
Category C
FDA Approved
Jan 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lubiprostone is a medication used to treat a type of constipation called Irritable Bowel Syndrome with Constipation (IBS-C). 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.
Keep it in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe 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 is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
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.
Keep it in a dry place, avoiding storage in a bathroom.
Keep all medications in a safe 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 is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the capsule whole with food and water to help reduce nausea.
- Maintain adequate hydration by drinking plenty of fluids throughout the day.
- Consider a diet rich in fiber, unless advised otherwise by your doctor.
- Engage in regular physical activity, which can help promote bowel regularity.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
8 mcg orally twice daily
Dose Range:
8 - 8 mg
Condition-Specific Dosing:
Irritable Bowel Syndrome with Constipation (IBS-C):
8 mcg orally twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Lubiprostone 24 mcg is approved for Chronic Idiopathic Constipation in children 6-17 years, but 8 mcg is not)
Adolescent:
Not established (Lubiprostone 24 mcg is approved for Chronic Idiopathic Constipation in children 6-17 years, but 8 mcg is not)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; minimal systemic exposure
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
For IBS-C (8 mcg BID), consider 8 mcg orally once daily
Severe:
For IBS-C (8 mcg BID), consider 8 mcg orally every other day
Pharmacology
Mechanism of Action
Lubiprostone is a bicyclic fatty acid 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, increases bowel movement frequency, and improves symptoms associated with chronic idiopathic constipation and irritable bowel syndrome with constipation.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely determined due to extensive first-pass metabolism
Tmax:
Approximately 1.14 hours
FoodEffect:
Taking with food may decrease peak concentration (Cmax) and delay time to peak concentration (Tmax), but does not affect overall exposure (AUC).
Distribution:
Vd:
Not determined
ProteinBinding:
Approximately 94% (parent drug)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 0.9 to 1.4 hours (parent drug)
Clearance:
Not determined
ExcretionRoute:
Primarily via feces (approximately 60% as metabolites), minimal renal excretion (<1% as parent drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 24 hours for initial bowel movement in some patients
PeakEffect:
Not directly applicable for a laxative effect, but consistent effects seen within the first week of treatment.
DurationOfAction:
Effects persist with continued dosing; short half-life requires twice-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While 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 may be at higher risk if you experience 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Headache
Stomach pain or diarrhea
Gas
Bloating
Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While 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 may be at higher risk if you experience 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Headache
Stomach pain or diarrhea
Gas
Bloating
Upset stomach
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 diarrhea (contact your doctor immediately)
- Severe nausea or vomiting that prevents you from taking the medication
- Sudden onset of difficulty breathing or shortness of breath
- Feeling dizzy or lightheaded, or fainting (syncope)
- Worsening abdominal pain or new symptoms of bowel obstruction
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. Do not initiate, stop, or modify the dosage 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. Do not initiate, stop, or modify the dosage 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 currently breast-feeding, be sure to discuss this with your doctor. Your doctor will need to weigh the benefits and risks of this medication for both you and your baby to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Nausea
- Vomiting
- Abdominal discomfort
What to Do:
There is no specific antidote for lubiprostone overdose. Management should be supportive and symptomatic, focusing on fluid and electrolyte replacement if severe diarrhea occurs. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Monitoring
Baseline Monitoring
Rule out mechanical bowel obstruction
Rationale: Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Timing: Prior to initiation of therapy
Assess constipation history and symptoms
Rationale: To confirm diagnosis and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Bowel movement frequency and consistency
Frequency: Daily or as needed
Target: Improved frequency and softer stools
Action Threshold: Lack of improvement after several weeks, or worsening constipation.
Adverse effects (e.g., nausea, diarrhea, abdominal pain, dyspnea, syncope)
Frequency: Regularly, especially during initial treatment
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or persistent symptoms warrant dose reduction or discontinuation.
Symptom Monitoring
- Severe diarrhea
- Severe nausea or vomiting
- Abdominal pain or cramping
- Dyspnea (shortness of breath)
- Syncope (fainting or dizziness)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Limited human data; animal data suggest potential risks.
Third Trimester:
Limited human data; animal data suggest potential risks.
Lactation
Caution advised. Lubiprostone and its active metabolite are excreted in the milk of lactating rats. It is not known whether lubiprostone is excreted in human milk. Weigh the developmental and health benefits of breastfeeding against 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:
Potential for diarrhea in breastfed infant; human data are limited.
Pediatric Use
The 8 mcg capsule is not approved for pediatric use. Lubiprostone 24 mcg is approved for Chronic Idiopathic Constipation (CIC) in children 6-17 years of age, but not for IBS-C. Safety and efficacy for IBS-C in pediatric patients have not been established.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to fluid and electrolyte imbalances due to diarrhea, and should be monitored closely.
Clinical Information
Clinical Pearls
- Always take lubiprostone with food and water to minimize the risk of nausea, which is a common side effect.
- Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction; ensure this is ruled out before starting therapy.
- Patients should be advised to discontinue lubiprostone and contact their healthcare provider if severe diarrhea occurs.
- The 8 mcg dose is specifically indicated for Irritable Bowel Syndrome with Constipation (IBS-C), while higher doses (24 mcg) are used for Chronic Idiopathic Constipation (CIC) and Opioid-Induced Constipation (OIC).
- Dyspnea (shortness of breath) and syncope (fainting) are rare but serious adverse effects that warrant immediate medical attention.
Alternative Therapies
- Linaclotide (Linzess)
- Plecanatide (Trulance)
- Prucalopride (Motegrity)
- Polyethylene Glycol (PEG) 3350 (MiraLAX)
- Fiber supplements (e.g., psyllium, methylcellulose)
- Stool softeners (e.g., docusate sodium)
- Osmotic laxatives (e.g., lactulose, magnesium hydroxide)
Cost & Coverage
Average Cost:
Varies widely; check current market data per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization)
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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.