Linzess is a prescription medicine used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults.

Linzess is also used to treat functional constipation (FC) in children and adolescents 6 to 17 years of age.

Linzess contains linaclotide which belongs to the class of drugs called guanylate cyclase-C agonists. The guanylate cyclase type-C (GC-C) receptor is located on the luminal surface of the intestine. Linaclotide works to treat IBS-C, CIC, and FC by stimulating the GC-C receptor to increase fluid secretion, which softens stools and stimulates bowel movements.

What is Linzess used to treat?

Linzess is used to treat certain types of constipation. Constipation is a condition in which you may have fewer bowel movements than expected, or you may have stools that are hard, dry, lumpy, or painful or difficult to pass.

Linzess is used in adults to treat irritable bowel syndrome with constipation (IBS-C). IBS-C is constipation that is associated with abdominal symptoms such as pain, discomfort and bloating.

Linzess is used in adults to treat chronic idiopathic constipation (CIC). CIC is constipation that keeps coming back or lasts for three months or more, with no known cause.

Linzess is also used in children and adolescents 6 to 17 years of age to treat functional constipation (FC). FC is constipation with no known cause.

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

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal. Do not crush, chew, break, or open a capsule. Swallow it whole.

Stop using this medicine and call your doctor at once if you have severe or ongoing diarrhea, severe stomach pain, or black, bloody, or tarry stools.

Take Linzess exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.

Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.

If needed, medicine from the Linzess capsule may be given through a nasogastric (NG) or gastronomy tube.

Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep this medicine out of the reach of children. Linaclotide can be fatal to a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

Usual Adult Dose for Irritable Bowel Syndrome with Constipation (IBS-C):

290 mcg orally once a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Usual Adult Dose for Chronic Idiopathic Constipation (CIC):

145 mcg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

Usual Pediatric Dose for Functional Constipation (FC):

72 mcg orally once a day

Use: Treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.

You should not use Linzess:

• if you are allergic to linaclotide, or

• if you have a blockage in your intestines (bowel obstruction).

It is not known if this medicine is safe and effective in children less than 6 years of age with functional constipation, or in children less than 18 years of age with IBS-C.

Linzess should not be given to a child younger than 2 years of age. Linaclotide can cause severe diarrhea and fatal dehydration in children who are younger than 2 years of age.

Tell your doctor if you are pregnant or breastfeeding.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Stop using Linzess and call your doctor at once if you have:

• severe or ongoing diarrhea; or

• diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common Linzess side effects may include:

• diarrhea;

• stomach pain;

• gas; or

• bloating or full feeling in your stomach.

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

Other drugs may interact with linaclotide, 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.