Motegrity

What is Motegrity used for?

• Motegrity is used to treat constipation.

Description

MOTEGRITY (prucalopride) tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate.

The molecular formula is C18H26ClN3O3.C4H6O4 and the molecular weight is 485.96. The structural formula is:

Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9.

Each 1-mg film-coated tablet of MOTEGRITY contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, and triacetin.

Each 2-mg film-coated tablet of MOTEGRITY contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, triacetin, red iron oxide, yellow iron oxide, and FD&C Blue #2.

Before taking Motegrity, tell your doctor:

• If you are allergic to Motegrity; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bowel problems like bowel block, Crohn’s disease, hole in the GI (gastrointestinal) tract, or ulcerative colitis.
• If you have kidney disease or are on dialysis.
• If you have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Motegrity with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Motegrity?

• Tell all of your health care providers that you take Motegrity. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Motegrity while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Motegrity best taken?

Use Motegrity as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking Motegrity as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Motegrity that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• New or worse behavior or mood changes like depression or thoughts of killing yourself.

What are some other side effects of Motegrity?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Motegrity?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

label

1 MG TABLET BOTTLE LABEL

• Rx Only
  NDC 54092-546-01
• motegrity®
  (prucalopride) tablets
• 1 mg
• Usual Dose: One tablet once daily.
  30 Tablets

2 MG TABLET BOTTLE CARTON

• NDC 54092-547-03
• motegrity®
  (prucalopride) tablets
• 2 mg
• Usual Dose: One tablet once daily.
  Patient Sample – Not for Sale
• 30 Tablets
• Rx Only
• Takeda

Use of consumer data and disclaimer

• If your symptoms or health concerns do not improve or worsen, consult your doctor.
• Do not share your medications with others or use others’ medications.
• Ter patient information leaflet may be available for some medications. 
• Consult your pharmacist for more information. 
• Please consult your doctor, nurse, pharmacist, or other health care provider if you have any questions regarding Motegrity.
• If you suspect an overdose, contact your local poison control center or seek medical attention right away. 
• Prepare to explain or demonstrate what was stolen, how much was taken, and when it occurred.

SRC: NLM.