TRULANCE Tablet Ref.[10170] Active ingredients: Plecanatide

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

TRULANCE is indicated in adults for the treatment of:

  • chronic idiopathic constipation (CIC).
  • irritable bowel syndrome with constipation (IBS-C)

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosage of TRULANCE for the treatment of CIC and IBS-C is 3 mg taken orally once daily.

2.2 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:

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

Oral Administration in Water:

  • Place the TRULANCE tablet in a clean cup.
  • Pour approximately 30 mL of room temperature water into the cup.
  • Mix by gently swirling the tablet and water mixture for at least 10 seconds. The TRULANCE tablet will fall apart in the water.
  • Swallow the entire contents of the tablet water mixture immediately.
  • 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.
  • Do not store the tablet-water mixture for later use.

Administration with Water via a Nasogastric or Gastric Feeding Tube:

  • Place the TRULANCE tablet in a clean cup with 30 mL of room temperature water.
  • Mix by gently swirling the tablet and water mixture for at least 15 seconds. The TRULANCE tablet will fall apart in the water.
  • Flush the nasogastric or gastric feeding tube with 30 mL of water using a catheter tip syringe.
  • Draw up the mixture using the syringe and immediately administer via the nasogastric or gastric feeding tube. Do not reserve for future use.
  • 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.
  • Using the same or a fresh syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.

16.2. Storage and Handling

Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep TRULANCE in a dry place. Protect from moisture. For bottles, keep TRULANCE in the original bottle. Do not remove desiccant from the bottle. Do not subdivide or repackage.

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