Amitiza 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, laxative
Pharmacologic Class
Chloride channel activator
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
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with food and a full glass of water. Swallow the tablet whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom. Ensure that all medications are kept in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with food and a full glass of water. Swallow the tablet whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom. Ensure that all medications are kept in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's 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 the missed one.
Lifestyle & Tips
- Take the capsule whole; do not break, chew, or crush it.
- Take with food and water to help reduce nausea.
- Maintain adequate hydration throughout the day.
- Engage in regular physical activity as tolerated.
- Consider increasing dietary fiber intake, unless advised otherwise by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
24 mcg orally twice daily
Dose Range:
24 - 24 mg
Condition-Specific Dosing:
Chronic Idiopathic Constipation (CIC):
24 mcg orally twice daily
Opioid-Induced Constipation (OIC):
24 mcg orally twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Consider starting at 12 mcg orally twice daily
Dialysis:
No specific recommendations; use with caution due to limited data.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Reduce dose to 16 mcg orally once daily initially
Severe:
Reduce dose to 8 mcg orally once daily initially
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 leads to an increase in intestinal fluid secretion, which softens the stool, increases stool volume, and promotes intestinal motility, thereby facilitating spontaneous bowel movements.
Pharmacokinetics
Absorption:
Bioavailability:
Not quantifiable (minimal systemic absorption)
Tmax:
Not applicable (parent drug not detectable in plasma)
FoodEffect:
Taking with food may reduce the incidence of nausea.
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Approximately 94% (for active metabolite M-3)
CnssPenetration:
Limited
Elimination:
HalfLife:
Parent drug: Not detectable in plasma; Metabolite M-3: Approximately 0.9 to 1.4 hours
Clearance:
Not available
ExcretionRoute:
Primarily via feces (approximately 60% as metabolites), with a small amount (<1%) excreted in urine.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within 24 hours for initial bowel movement
PeakEffect:
Not precisely defined, but sustained effect with continued dosing
DurationOfAction:
Not precisely defined, but effect persists with twice-daily dosing
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 may be at higher risk if you experience diarrhea or vomiting, which can increase the chance of low blood pressure. 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 may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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, 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. Your doctor can provide medical advice and guidance on managing side effects.
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 may be at higher risk if you experience diarrhea or vomiting, which can increase the chance of low blood pressure. 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 may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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, 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. Your doctor can provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe diarrhea (contact your doctor immediately)
- Severe nausea or vomiting
- Severe abdominal pain or bloating
- Difficulty breathing or chest tightness (dyspnea)
- Fainting or feeling lightheaded (syncope)
- Symptoms 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 symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Diarrhea
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. 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 symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Diarrhea
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all 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, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby, to determine the best course of action.
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. 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, OIC)
Rationale: To ensure appropriate indication for lubiprostone use.
Timing: Prior to initiation
Rule out mechanical obstruction
Rationale: Lubiprostone is contraindicated in patients with known or suspected gastrointestinal obstruction.
Timing: Prior to initiation
Routine Monitoring
Frequency and consistency of bowel movements
Frequency: Daily initially, then as needed
Target: Improved bowel habits (e.g., ≥3 complete spontaneous bowel movements per week)
Action Threshold: Lack of improvement or worsening of constipation after several weeks of therapy may warrant re-evaluation.
Adverse effects (e.g., nausea, diarrhea, abdominal pain, dyspnea)
Frequency: Regularly, especially during initial therapy
Target: Tolerable side effect profile
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Symptom Monitoring
- Nausea (common, can be reduced by taking with food)
- Diarrhea (common, may be severe)
- Abdominal pain/distension
- Flatulence
- Headache
- Dyspnea (shortness of breath, chest tightness - rare but reported, usually resolves spontaneously)
- Syncope (rare)
Special Patient Groups
Pregnancy
Lubiprostone is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data; human data lacking.
Second Trimester:
Potential risk based on animal data; human data lacking.
Third Trimester:
Potential risk based on animal data; human data lacking.
Lactation
It is not known whether lubiprostone or its metabolites are excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be low. However, caution should be exercised when lubiprostone is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered 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 - Moderate risk, limited human data, low systemic absorption)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients younger than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. No specific dose adjustment is required based on age alone, but consider age-related decline in renal or hepatic function when determining dose.
Clinical Information
Clinical Pearls
- Always take lubiprostone with food and water to minimize the risk of nausea, which is a common side effect.
- Patients should be advised that the onset of action is typically within 24 hours, but consistent daily dosing is key for sustained relief.
- Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction; always rule this out before initiating therapy.
- For patients experiencing severe diarrhea, temporary discontinuation or dose reduction may be necessary.
- Dyspnea (shortness of breath) is a rare but reported side effect; patients should be advised to report this symptom, which usually resolves spontaneously within a few hours.
Alternative Therapies
- Linaclotide (Linzess)
- Plecanatide (Trulance)
- Prucalopride (Motegrity)
- Polyethylene glycol (PEG) 3350 (MiraLAX)
- Lactulose
- Bisacodyl
- Senna
- Fiber supplements (e.g., psyllium, methylcellulose)
- Stool softeners (e.g., docusate sodium)
Cost & Coverage
Average Cost:
$300 - $500+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (requires prior authorization for some plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.