Trulance treats constipation in people with chronic constipation.
Take one Trulance 3 mg tablet by mouth daily with or without food.
For people who cannot swallow pills, Trulance can be mixed with applesauce for easier dosing.
The most common and rarely hazardous side effect of Trulance is diarrhea. Contact the prescriber if the drug causes severe diarrhea.
Trulance is a brand-name prescription drug that treats chronic constipation: chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C). Its active ingredient, plecanatide, is a powerful drug that increases fluid absorption inside the intestine to soften stools and speed transit through the bowels. Its most common and potentially most serious side effect is diarrhea, which can be severe. Because of potentially severe diarrhea and the risk of serious dehydration, Trulance is not used in patients younger than 18 years.
Trulance comes in only one dosage form: 3 mg tablets. Dosages do not change for any reason.
Tablets: 3 mg
Trulance treats chronic constipation in people diagnosed with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Doses are taken once daily.
Trulance is not safe for everyone. Children younger than 6 years of age and anyone with gastrointestinal blockage cannot safely take It. The safety and effectiveness of Trulance have not been established in patients younger than 18.
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Trulance dosage chart |
|||
|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| Chronic idiopathic constipation | 3 mg tablet once daily | 3 mg tablet once daily | 3 mg daily |
| Irritable bowel syndrome with constipation | 3 mg tablet once daily | 3 mg tablet once daily | 3 mg daily |
Chronic idiopathic constipation is a common disorder affecting about 1 in 10 people in the United States. It has no known cause (that’s what “idiopathic” means) and is characterized by infrequent or incomplete bowel movements as well as other common symptoms of constipation.
Many CIC cases are effectively treated with dietary changes and gentle laxatives. Still, more stubborn cases may require stronger laxatives or prescription drugs that speed up intestinal contractions (prokinetic agents) or increase the secretion of fluids into the large intestine (prosecretory agents). Plecanatide, the active ingredient in Trulance, is a prosecretory agent. As a guanylate cyclase-C agonist, it stimulates the secretion of fluid into the bowel. The extra liquid softens stools and speeds up the movement of stools through the colon.
Doses are taken once daily by mouth with or without food. There are no starting doses or dosing schedules, and doses are not changed during treatment for any reason. The recommended dosage is the maximum dosage.
Standard dosage for chronic idiopathic constipation: One 3 mg tablet taken by mouth once daily
Maximum dosage for chronic idiopathic constipation: 3 mg daily
Irritable bowel syndrome is a constellation of digestive system problems, including abdominal pain, discomfort, bloating, cramping, diarrhea, and constipation. The last two are total opposites. You can’t have both at the same time, so people can go back and forth – diarrhea one time, constipation the next. Some people have IBS with mainly diarrhea (IBS-D), and some have IBS with mainly constipation (IBS-C). That’s “mainly,” not “always.” People with IBS-C can have diarrhea during some flare-ups.
IBS is a common condition, affecting 3% to 20% of people living in the U.S. IBS-C affects about 1/3
of those people. While IBS involves several treatments for the many symptoms, healthcare professionals treat the constipation component with dietary changes, over-the-counter laxatives, and, in more serious cases, prescription drugs like Trulance.
As with CIC, Trulance doses are taken once daily by mouth with or without food. There are no starting doses or dosage changes.
Standard dosage for irritable bowel syndrome with constipation: One 3 mg tablet taken once daily
Maximum dosage for irritable bowel syndrome with constipation: 3 mg daily
Trulance is not FDA-approved for use in children. Because of the risk of severe dehydration and subsequent death, it is contraindicated in children younger than 6 years of age. Healthcare professionals avoid prescribing Trulance to any person younger than 18 years of age.
Healthcare professionals do not need to modify or restrict doses in people with liver disease, kidney disease, or other medical conditions.
Trulance is a once-daily pill. It can be crushed and mixed with applesauce or dissolved in water for people who have trouble swallowing a tablet. It can also be prepared for use with a nasogastric feeding tube.
Take only one pill by mouth daily. The dose will not change.
Follow all the prescriber’s instructions.
Please read the medication guide that comes with this drug.
Doses can be taken with a meal or on an empty stomach.
Swallow the tablet whole.
For people who cannot swallow a tablet, the tablet can be crushed and mixed with applesauce:
In a clean container, crush the tablet into a powder.
Mix it with one teaspoonful of room-temperature applesauce.
Swallow the entire mixture immediately. Do not save it for later use.
The tablet can also be dissolved in water:
Put the tablet in a clean cup.
Pour one ounce of room-temperature water into the cup.
Swirl the tablet around in the water for at least 10 seconds.
Immediately swallow the entire water mixture. Do not save it for later use.
If any powder or tablet remains at the bottom of the glass, add another ounce of water to the cup. Swirl it around for 10 seconds, then swallow it right away.
The tablet can also be dissolved in water and administered through a gastric feeding tube. The Medication Guide has complete instructions.
Store Trulance tablets in their original container at room temperature in a dry place.
You can remove the polyester coil from the bottle but keep the small packet in it. This will help keep the tablets dry.
Just like laxatives, plecanatide works shortly after a dose is taken. However, Trulance is a treatment for a chronic condition, so it “works” only by reducing the incidence of straining, hard stools, infrequent bowel movements, incomplete bowel movements, or other symptoms of constipation over a long period. Clinical studies lasted 12 weeks. Don’t be disappointed if it doesn’t work the first day. Take the pills for a few months. Success is measured by improving the condition, not by eliminating it entirely.
Trulance is not absorbed in significant amounts into the body as it primarily works and is broken down by the intestines. The body breaks plecanatide down into smaller molecules in the digestive system and eliminates them through the stools.
Skip any missed dose. Take the next dose at its regularly scheduled time. Do not take two tablets to make up for a missed dose.
Trulance is intended as a long-term treatment for chronic constipation. Healthcare professionals can prescribe it for as long as it works without causing significant adverse effects.
People can stop taking Trulance at any time without experiencing adverse withdrawal effects. Before stopping, talk to the prescriber. If another suitable treatment is not substituted, constipation may return.
Trulance can be discontinued if it causes severe diarrhea or doesn’t work. Fortunately, healthcare professionals have other effective treatment options for both IBS-C and CIC, including dietary changes, lifestyle changes, and OTC laxatives. Unfortunately, many of these have probably been tried and failed.
Healthcare providers will probably turn to other prescription drugs. They may substitute drugs similar to Trulance, such as Linzess (linactolide) or Amitizia (lubiprostone). They may also use medications that stimulate large bowel motility, such as Motegrity (prucalopride) for CIC or (off-label) for IBS-C.
The recommended dosage of Trulance (3 mg daily) is the maximum dosage.
Take only one 3 mg tablet daily. An overdose of Trulance could cause diarrhea and dehydration severe enough to require medical care. Whether due to an overdose or not, anyone who experiences severe diarrhea while taking Trulance should immediately stop taking doses and go to an emergency room.
Trulance has no known drug interactions. Even so, tell the prescribing healthcare provider and pharmacist about all the drugs and supplements being taken.
Drinking alcohol is not prohibited when taking Trulance. However, alcohol may contribute to constipation or worsen IBS symptoms. Dietary changes are a critical aspect of CIC and IBS treatment, so get medical advice about what and how much to drink.
Healthcare providers do not know if Trulance is a risk during pregnancy or causes birth defects. However, they believe it’s unlikely to harm a fetus since only tiny amounts of the drug leave the intestines. Tell the prescriber if you are pregnant or planning to become pregnant if you are taking Trulance.
Healthcare professionals do not believe that Trulance can affect lactation or a nursing infant. In clinical studies, researchers could not find detectable levels of plecanatide or its active metabolite in breast milk in women taking Trulance for two weeks. If you are concerned, ask the prescriber for medical advice.
The most common side effect of Trulance is diarrhea. About 1 in 20 people in clinical trials reported problems with diarrhea. Severe diarrhea is the most common severe side effect, as well. Less common side effects include flatulence, nausea, sore throat, infection, dizziness, and mild allergic reactions such as skin rash or hives.
American Gastroenterological Association-American College of Gastroenterology clinical practice guideline: Pharmacological management of chronic idiopathic constipation, Gastroenterology (American Gastroenterological Association)
Constipation-predominant irritable bowel syndrome; a review of current and emerging drug therapies, World Journal of Gastroenterology
Plecanatide (Trulance) for chronic idiopathic constipation and irritable bowel syndrome with constipation, Pharmacy & Therapeutics
Relationship between patterns of alcohol consumption and gastrointestinal symptoms among patients with irritable bowel syndrome, The American Journal of Gastroenterology
The epidemiology of irritable bowel syndrome in North America: a systematic review, The American Journal of Gastroenterology
Trulance drug summary, Prescriber’s Digital Reference (PDR)
Trulance plecanatide tablet prescribing information, DailyMed (NIH National Library of Medicine)
Leslie Greenberg, MD, is a board-certified practicing family physician with more than 25 years of doctoring experience. She was a psychology major at Northwestern University near Chicago, then graduated with an MD from the University of Nevada School of Medicine. She completed her family medicine residency at St. Joseph Hospital in Wichita, Kansas. She has trained more than 350 family medicine resident-physicians, been in private practice, and delivered babies for 22 years.
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