Glossary

Disease Education Terms

A

Abdominal distension: a measurable increase in the size of the abdomen.

Active cancer: cancer is the state of abnormal cells growing too fast, crowding normal cells and making it hard for the body to work the way it is supposed to. Cancer is considered to be active when someone is currently recommended for, waiting for, or receiving treatment.

B

Bowel blockage: a serious problem that happens when something blocks the bowel (either your large or small intestine).

Bowel movement: the discharge of waste (usually solid) from the rectum and anus.

Bowel movement frequency: how often bowel movements occur.

Bristol Stool Form Scale (BSFS): a 7-point scale used to identify different types of stool forms.

C

Chronic Idiopathic Constipation (CIC): a long-term condition with no known reason that causes people to struggle to have regular bowel movements.

Constipation: the condition of having stools that do not happen often or are hard to pass.

E

Electrolyte: any of the minerals (like sodium or calcium) that regulate or affect most metabolic processes (such as the flow of nutrients into, and waste products out of, cells).

F

Food and Drug Administration (FDA): the US federal agency responsible for protecting the public health by ensuring safety, efficacy and security of products such as drugs, medical devices and food.

Fetal: of or relating to a developing human being that is not yet born.

G

GastrointestinaI (GI): relating to the stomach and intestines. Common GI disorders include heartburn, indigestion, bloating, and constipation.

H

Health Care Provider (HCP): a general term for any healthcare institution member providing healthcare such as doctors, nurses, surgeons, etc.

I

Idiopathic: any disease or condition for which the cause is unknown.

Irritable Bowel Syndrome with Constipation (IBS-C): Irritable Bowel Syndrome (IBS) is a common disorder that affects the large intestine. Symptoms can include cramping, stomach pain, bloating, gas, diarrhea, or constipation. IBS-C is a specific type of IBS in which abdominal discomfort or bloating happen with constipation.

L

Laxatives: medications used to help increase bowel movements.

O

Opioid-Induced Constipation (OIC): constipation caused by taking opioids, a type of prescription pain medication.

Opioids: a type of prescription pain medication.

P

Placebo: something given to patients that has no physical effect on the body.

R

Receptors: proteins that help cells communicate messages and bring about responses. Different receptors are specific for communicating different types of messages.

Recurring: happening multiple times.

Savings and Support Terms

A

Amended: changed or modified, usually to make a correction or improvement.

B

Beneficiary: a person that receives help or an advantage from something.

C

Commercially insured: having health insurance that is not provided by the government.

R

Rescinded: to have taken something back.

Revoked: to have canceled something by taking it back.

T

Third party: a group or person that is not principal in an agreement, deal, or situation.

Uses & Important Safety Information

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AMITIZA is used for 3 types of chronic constipation: CIC in adults, OIC in adults with chronic pain that is not caused by active cancer, and IBS-C in women ≥ 18 years. Effectiveness in patients taking methadone has not been established.

Important Safety Information

AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA.

Some patients taking AMITIZA may experience nausea. Take AMITIZA with food and water to reduce the occurrence of nausea.

Do not take AMITIZA if you have severe diarrhea. Some patients taking AMITIZA may experience diarrhea. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms.

The most common side effects of taking AMITIZA 24 mcg twice daily for CIC are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas. The most common side effects of taking AMITIZA 24 mcg twice daily for Opioid-Induced Constipation are nausea and diarrhea. The most common side effects of taking AMITIZA 8 mcg twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indications

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic pain that is not caused by active cancer. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years of age.

Please click here for complete Prescribing Information.

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