Plecanatide

Plecanatide is used to treat chronic idiopathic constipation or irritable bowel syndrome with constipation.

Plecanatide may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Swallow the tablet whole, with or without food.

If you cannot swallow the tablet whole, you may crush and mix the tablet with a spoonful of water or applesauce. Swallow this mixture right away. Do not save it for later use.

This tablet mixture with water may also be given through a nasogastric (NG) feeding tube using a catheter-tipped syringe. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Store at room temperature away from moisture and heat.

Keep the tablets in their original bottle or blister pack until you are ready to take one. You may remove the packing coil from inside the pill bottle. But leave the packet or canister of moisture-absorbing preservative inside the bottle.

You should not use plecanatide if you have a blockage in your intestines.

Do not give plecanatide 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 a child younger than 6 years old.

Avoid using plecanatide in anyone younger than 18 years old. In animal studies, plecanatide caused severe dehydration leading to death.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Diarrhea is a common side effect of plecanatide. Stop using plecanatide and call your doctor immediately if your diarrhea is severe.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Chronic Idiopathic Constipation:

3 mg orally once a dayUse: Treatment of chronic idiopathic constipation (CIC)

Usual Pediatric Dose for Chronic Idiopathic Constipation:

-Under Age 6 Years: Contraindicated.-Age 6 to Under 18 Years: Not recommended.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

An overdose of plecanatide is not expected to be dangerous. Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if someone accidentally swallows the medication. A child under 6 who takes plecanatide may become severely dehydrated.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may affect plecanatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.