Brand Names: Linzess

Generic Name: linaclotide

What is linaclotide (Linzess)?
What are the possible side effects of linaclotide (Linzess)?
What is the most important information I should know about linaclotide (Linzess)?
What should I discuss with my healthcare provider before taking linaclotide (Linzess)?
How should I take linaclotide (Linzess)?
What happens if I miss a dose (Linzess)?
What happens if I overdose (Linzess)?
What should I avoid while taking linaclotide (Linzess)?
What other drugs will affect linaclotide (Linzess)?
Where can I get more information (Linzess)?

What is linaclotide (Linzess)?

Linaclotide works by increasing the secretion of chloride and water in the intestines, which can soften stools and stimulate bowel movements.

Linaclotide is used to treat chronic constipation, or chronic irritable bowel syndrome (IBS) in people who have had constipation as the main symptom.

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

004561201_PB

capsule, white, imprinted with FL 145

004561202_PB

capsule, white, imprinted with FL 290

What are the possible side effects of linaclotide (Linzess)?

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

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

severe or ongoing diarrhea;
diarrhea with dizziness or a light-headed feeling (like you might pass out);
signs of an electrolyte imbalance--increased thirst or urination, leg cramps, mood changes, confusion, feeling unsteady, irregular heartbeats, fluttering in your chest, muscle weakness or limp feeling;
severe stomach pain; or
black, bloody, or tarry stools.

Common 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.

What is the most important information I should know about linaclotide (Linzess)?

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

Linaclotide should not be given to a child younger than 6 years old. Linaclotide can cause severe dehydration in a child.

What should I discuss with my healthcare provider before taking linaclotide (Linzess)?

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

a blockage in your intestines.

Linaclotide can cause severe dehydration in a child. Linaclotide should not be given to a child younger than 6 years old. Do not give this medicine to any child or teenager without the advice of a doctor.

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

It is not known whether linaclotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take linaclotide (Linzess)?

Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Do not crush, chew, or break a linaclotide capsule. Swallow it whole.

If you cannot swallow the linaclotide capsule whole, you may open the capsule 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 linaclotide capsule may be given through a nasogastric (NG) or gastronomy tube.

Read all patient information, medication guides, and instruction sheets provided to you. 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. Call your doctor if your symptoms do not improve, or if they get worse while using linaclotide.

Store at room temperature away from moisture and heat. Keep this medicine out of the reach of children. Linaclotide can cause severe diarrhea and dehydration in a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

Keep the capsules in their original container, along with the packet of moisture-absorbing preservative that comes with this medicine. Keep the bottle tightly closed when not in use.

SLIDESHOW

Heart Disease: Causes of a Heart Attack See Slideshow

What happens if I miss a dose (Linzess)?

Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Linzess)?

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

What should I avoid while taking linaclotide (Linzess)?

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

What other drugs will affect linaclotide (Linzess)?

Other drugs may interact with linaclotide, including prescription, over-the-counter, vitamin, and herbal products. Tell your doctor about all medications you use, and those you start or stop using during your treatment with linaclotide.

Where can I get more information (Linzess)?

Your pharmacist can provide more information about linaclotide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.