Trulance

Name: Trulance

What Is Trulance?

Plecanatide is used to treat chronic idiopathic constipation.

Plecanatide works by activating certain substances within your intestines that help increase fluid secretion and muscle movement. Plecanatide also causes changes in the consistency of your stools.

Plecanatide may also be used for purposes not listed in this medication guide.

You should not use plecanatide if you are allergic to it, or if you have a blockage in your intestines. Do not give this medicine to a child younger than 6 years old.

Plecanatide is not approved for use by anyone younger than 18 years old.

You should not use plecanatide if you are allergic to it, or if you have:

  • a blockage in your intestines.

Do not give this medicine to younger than 6 years old.

Plecanatide is not approved for use by anyone younger than 18 years old. In animal studies, plecanatide caused severe dehydration leading to death.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether plecanatide passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

What is the most important information I should know about plecanatide?

You should not use plecanatide if you are allergic to it, or if you have a blockage in your intestines. Do not give this medicine to a child younger than 6 years old.

Plecanatide is not approved for use by anyone younger than 18 years old.

What should I discuss with my healthcare provider before taking plecanatide?

You should not use plecanatide if you are allergic to it, or if you have:

  • a blockage in your intestines.

Do not give this medicine to younger than 6 years old.

Plecanatide is not approved for use by anyone younger than 18 years old. In animal studies, plecanatide caused severe dehydration leading to death.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether plecanatide passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Actions

  • Binds to GC-C receptor on luminal surface of intestinal epithelium.1 2 6 7 9 Stimulation of GC-C causes increased concentrations of cyclic guanosine monophosphate (cGMP), which activates the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel leading to secretion of chloride and bicarbonate into intestinal lumen; results in increased intestinal fluid and accelerated intestinal transit.1 2 6 7 8 9

  • Reduces abdominal muscle contractions, increases fluid secretion into the GI tract, accelerates intestinal transit, and changes stool consistency in animal models.1

Trulance Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Severe diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Mild diarrhea
Less common or rare
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • excess air or gas in the stomach or intestines
  • fever
  • full or bloated feeling
  • headache
  • loss of voice
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • pressure in the stomach
  • runny nose
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swelling of the abdominal or stomach area
  • tightness of the chest
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Uses of Trulance

  • It is used to treat hard stools (constipation).

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Trulance?

  • Store in the original container at room temperature.
  • Keep lid tightly closed.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Trulance Dosage and Administration

Recommended Dosage

The recommended dosage of Trulance is 3 mg taken orally once daily.

Preparation and Administration Instructions

  • Take Trulance with or without food [see Clinical Pharmacology (12.3)].
  • If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.
  • Swallow a tablet whole for each dose.
  • For adult patients with swallowing difficulties, Trulance tablets can be crushed and administered orally either in applesauce or with water or administered with water via a nasogastric or gastric feeding tube. Mixing Trulance crushed tablets in other soft foods or in other liquids has not been tested.

Oral Administration in Applesauce:

  1. In a clean container, crush the Trulance tablet to a powder and mix with 1 teaspoonful of room temperature applesauce.
  2. Consume the entire tablet-applesauce mixture immediately. Do not store the mixture for later use.

Oral Administration in Water:

  1. Place the Trulance tablet in a clean cup.
  2. Pour approximately 30 mL of room temperature water into the cup.
  3. Mix by gently swirling the tablet and water mixture for at least 10 seconds. The Trulance tablet will fall apart in the water.
  4. Swallow the entire contents of the tablet water mixture immediately.
  5. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 10 seconds, and swallow immediately.
  6. Do not store the tablet-water mixture for later use.

Administration with Water via a Nasogastric or Gastric Feeding Tube:

  1. Place the Trulance tablet in a clean cup with 30 mL of room temperature water.
  2. Mix by gently swirling the tablet and water mixture for at least 15 seconds. The Trulance tablet will fall apart in the water.
  3. Flush the nasogastric or gastric feeding tube with 30 mL of water using an appropriate syringe.
  4. Draw up the mixture using the syringe and immediately administer via the nasogastric or gastric feeding tube. Do not reserve for future use.
  5. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 15 seconds, and using the same syringe, administer via the nasogastric or gastric feeding tube.
  6. Using the same or a fresh syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.

What is Trulance?

Trulance (plecanatide) is used to treat chronic idiopathic constipation.

Trulance works by activating certain substances within your intestines that help increase fluid secretion and muscle movement.

Trulance also causes changes in the consistency of your stools.

Important information

You should not use Trulance if you are allergic to plecanatide, or if you have a blockage in your intestines. Do not give this medicine to a child younger than 6 years old.

Trulance is not approved for use by anyone younger than 18 years old.

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