Trulance 3mg Tablets
WARNING: Avoid use of this drug in children younger than 18 years of age. In animal studies, death from dehydration happened in young mice after taking this drug. If you have questions, talk with the doctor. @ COMMON USES: It is used to treat certain kinds of long-lasting constipation.It is used to treat irritable bowel syndrome with constipation (IBS-C).
Drug Class
Guanylate Cyclase-C Agonist
Pharmacologic Class
Guanylate Cyclase-C Agonist
Pregnancy Category
Not available
FDA Approved
Jan 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Trulance is a medication used to treat chronic constipation and irritable bowel syndrome with constipation. It works by increasing fluid in your intestines, which helps to soften stool and make bowel movements easier and more frequent.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Swallow the tablet whole with a glass of water. If you have difficulty swallowing the tablet, you can crush it and mix it with applesauce or dissolve it in water, as directed by your doctor. After mixing, take the dose immediately and do not store it for later use.
If you have a feeding tube, you can use this medication as instructed by your doctor. After administering the medication through the feeding tube, be sure to flush the tube.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, away from the bathroom. Keep it in the original container with the lid tightly closed. The container includes a desiccant packet and a polyester coil to maintain the medication's quality. Do not eat the desiccant packet or the polyester coil; keep the desiccant packet in the bottle and discard the polyester coil.
Missing a Dose
If you miss a dose, skip it and take the next dose at the scheduled time. Do not take two doses at once or take extra doses to make up for the missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Swallow the tablet whole with a glass of water. If you have difficulty swallowing the tablet, you can crush it and mix it with applesauce or dissolve it in water, as directed by your doctor. After mixing, take the dose immediately and do not store it for later use.
If you have a feeding tube, you can use this medication as instructed by your doctor. After administering the medication through the feeding tube, be sure to flush the tube.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, away from the bathroom. Keep it in the original container with the lid tightly closed. The container includes a desiccant packet and a polyester coil to maintain the medication's quality. Do not eat the desiccant packet or the polyester coil; keep the desiccant packet in the bottle and discard the polyester coil.
Missing a Dose
If you miss a dose, skip it and take the next dose at the scheduled time. Do not take two doses at once or take extra doses to make up for the missed dose.
Lifestyle & Tips
- Maintain adequate hydration by drinking plenty of fluids throughout the day.
- Increase dietary fiber intake gradually, unless advised otherwise by your doctor.
- Engage in regular physical activity to help promote bowel regularity.
- Do not crush, chew, or break the tablet. Swallow it whole.
- Take Trulance at approximately the same time each day.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
3 mg orally once daily
Dose Range:
3 - 3 mg
Condition-Specific Dosing:
Chronic Idiopathic Constipation (CIC):
3 mg orally once daily
Irritable Bowel Syndrome with Constipation (IBS-C):
3 mg orally once daily
Pediatric Dosing
Neonatal:
Contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
Infant:
Contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
Child:
Contraindicated in patients less than 6 years of age. Avoid use in patients 6 to less than 12 years of age due to the risk of serious dehydration.
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
No dosage adjustment necessary. Plecanatide is minimally absorbed systemically.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Pharmacology
Mechanism of Action
Plecanatide is a guanylate cyclase-C (GC-C) agonist. It acts locally in the gastrointestinal tract by binding to and activating GC-C receptors on the apical surface of intestinal epithelial cells. Activation of GC-C results in an increase in the intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Increased intracellular cGMP stimulates the secretion of chloride and bicarbonate into the intestinal lumen, primarily through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, leading to increased intestinal fluid and accelerated transit. Increased extracellular cGMP may decrease visceral pain.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.001% of the administered dose)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Food does not affect the systemic exposure of plecanatide.
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily fecal
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within 24 hours for some patients, but full effect may take several days to weeks.
PeakEffect:
Not applicable (based on systemic concentration, as it acts locally)
DurationOfAction:
Not available (continuous daily dosing required for effect)
Safety & Warnings
BLACK BOX WARNING
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS. Trulance is contraindicated in patients less than 6 years of age. In clinical studies, the incidence of diarrhea in pediatric patients treated with plecanatide was higher than in adults. The risk of serious dehydration in pediatric patients is increased, particularly in those less than 2 years of age. Avoid use in patients 6 years to less than 12 years of age.
Side Effects
Serious 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
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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Diarrhea
Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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
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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Diarrhea
Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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 diarrhea (watery, frequent stools)
- Dizziness or lightheadedness
- Signs of dehydration (e.g., extreme thirst, decreased urination, dry mouth, confusion)
- New or worsening abdominal pain
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.
If you have a bowel blockage, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter drugs, as well as natural products and vitamins
Health problems
with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust 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 symptoms you experienced.
If you have a bowel blockage, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter drugs, as well as natural products and vitamins
Health problems
with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 experience diarrhea while taking this drug, it is crucial to prevent dehydration by drinking plenty of fluids and monitoring your weight for any significant loss. If you notice any of these symptoms, consult your doctor promptly. In the event of accidental ingestion, seek immediate medical attention. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Dehydration
- Electrolyte imbalances
What to Do:
In case of overdose, discontinue Trulance and initiate symptomatic and supportive therapy as clinically indicated. Rehydration and correction of electrolyte imbalances may be necessary. Call 911 or your local poison control center (1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of CIC or IBS-C
Rationale: Confirm appropriate indication for therapy.
Timing: Prior to initiation
Rule out mechanical obstruction
Rationale: Plecanatide is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Timing: Prior to initiation
Routine Monitoring
Frequency and consistency of bowel movements
Frequency: Daily
Target: Improved bowel habits, reduced straining
Action Threshold: Persistent lack of improvement after several weeks of therapy may warrant re-evaluation.
Diarrhea
Frequency: Daily
Target: Absence or mild, manageable diarrhea
Action Threshold: Severe diarrhea, especially with signs of dehydration or electrolyte imbalance, requires discontinuation and medical attention.
Symptom Monitoring
- Severe diarrhea
- Dizziness
- Lightheadedness
- Excessive thirst
- Decreased urination
- Signs of dehydration (e.g., dry mouth, reduced skin turgor)
Special Patient Groups
Pregnancy
Minimal systemic absorption is expected to result in low maternal and fetal exposure. Available data from postmarketing reports with plecanatide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider the benefits and risks.
Trimester-Specific Risks:
First Trimester:
Low risk expected due to minimal systemic absorption.
Second Trimester:
Low risk expected due to minimal systemic absorption.
Third Trimester:
Low risk expected due to minimal systemic absorption.
Lactation
Plecanatide and its active metabolite are minimally absorbed systemically, and therefore, breastfed infants are not expected to be exposed to plecanatide. No data are available on the presence of plecanatide in human milk, the effects on the breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Trulance and any potential adverse effects on the breastfed infant from Trulance or from the underlying maternal condition.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Contraindicated in patients less than 6 years of age due to the risk of serious dehydration. Avoid use in patients 6 years to less than 12 years of age due to the risk of serious dehydration. Safety and effectiveness have not been established in pediatric patients 6 to less than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. No dosage adjustment is necessary. However, elderly patients may be more susceptible to dehydration and should be monitored carefully.
Clinical Information
Clinical Pearls
- Trulance is a locally acting drug with minimal systemic absorption, which contributes to its low potential for systemic side effects and drug interactions.
- The most common side effect is diarrhea. Patients should be advised to discontinue the drug and contact their healthcare provider if severe diarrhea occurs.
- It is crucial to educate patients and caregivers about the Black Box Warning regarding the risk of serious dehydration in pediatric patients, especially those under 6 years of age.
- Patients should be encouraged to maintain adequate hydration while on Trulance.
- Unlike some other constipation medications, Trulance can be taken with or without food.
Alternative Therapies
- Linaclotide (Linzess)
- Lubiprostone (Amitiza)
- Prucalopride (Motegrity)
- Tegaserod (Zelnorm) - for IBS-C in women <65 with no history of cardiovascular ischemic events
- Osmotic laxatives (e.g., polyethylene glycol, lactulose)
- Bulk-forming laxatives (e.g., psyllium, methylcellulose)
- Stimulant laxatives (e.g., bisacodyl, senna) - generally for short-term use
- Fiber supplementation
- Dietary and lifestyle modifications
Cost & Coverage
Average Cost:
$450 - $600 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.