Pentasa

What is Pentasa used for?

Pentasa is used to treat ulcerative colitis. It is used to help keep ulcerative colitis flares from coming back. Pentasa may be given to you for other reasons. Talk to your doctor.

Description

PENTASA (mesalamine) for oral administration is an extended-release formulation of mesalamine, an aminosalicylate anti-inflammatory agent for gastrointestinal use.

Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. It has a molecular weight of 153.14.

The structural formula is:

Each 250-mg capsule contains 250 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains D&C Yellow #10, FD&C Blue #1, FD&C Green #3, gelatin, titanium dioxide, and other ingredients.

Each 500-mg capsule contains 500 mg of mesalamine. It also contains the following inactive ingredients: acetylated monoglyceride, castor oil, colloidal silicon dioxide, ethylcellulose, hydroxypropyl methylcellulose, starch, stearic acid, sugar, talc, and white wax. The capsule shell contains FD&C Blue #1, gelatin, titanium dioxide, and other ingredients.

Before taking Pentasa, tell your doctor:

• If you are allergic to Pentasa; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

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 Pentasa 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 Pentasa?

• Tell all of your health care providers that you take Pentasa. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Pentasa.
• If you are 65 or older, use Pentasa with care. You could have more side effects.
• Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Pentasa best taken?

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

• Take with or without food.
• Take with a full glass of water.
• Swallow whole. Do not chew or crush.
• If you cannot swallow Pentasa whole, you may sprinkle the contents on applesauce or yogurt. Swallow the mixture right away without chewing.
• Keep taking Pentasa 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 Pentasa 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.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Some people may have a reaction to Pentasa that looks like the signs of ulcerative colitis. Call your doctor right away if you have very bad belly pain or cramps, bloody stools, fever, headache, or rash.
• Liver problems have rarely happened with Pentasa. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Some heart problems have rarely happened with Pentasa. Sometimes, this has been deadly. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs.

What are some other side effects of Pentasa?

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:

• Stomach pain or diarrhea.
• Upset stomach or throwing up.
• Heartburn.
• Constipation.
• Gas.
• Burping.
• Nose or throat irritation.
• Headache.
• Dizziness.
• Back pain.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

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 Pentasa?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Some products may come with a desiccant (protects the product from moisture) in the container, If the container comes with a desiccant, keep it in the bottle. Some brands may be stored without the desiccant for some time. Talk with the doctor or pharmacist if you are not sure.
• 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

PRINCIPAL DISPLAY PANEL – 250 MG CAPSULE BOTTLE LABEL

• 189-81
  NDC 54092-189-81
• Pentasa®
  (mesalamine)
• Extended-Release
  Capsules
• 240 CAPSULES
• Rx only
• 250 mg
• Takeda

PRINCIPAL DISPLAY PANEL – 500 MG CAPSULE BOTTLE LABEL

• 191-12
  NDC 54092-191-12
• Pentasa®
  (mesalamine)
• Extended-Release
  Capsules
• 120 CAPSULES
• Rx only
• 500 mg
• Takeda

SRC: NLM .