Generic name: mesalamine
Dosage form: oral delayed-release capsule
Drug class: 5-aminosalicylates
Medically reviewed by A Ras MD.
What is Delzicol?
Delzicol is used to treat ulcerative colitis. It is used to help keep ulcerative colitis flares from coming back. Delzicol may be given to you for other reasons.
Each DELZICOL (mesalamine) delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. DELZICOL (mesalamine) delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is:
Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red (3.44 mg), ferric oxide yellow (0.62 mg), lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC).
Mechanism of Action
The mechanism of action of mesalamine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Before taking Delzicol, tell your doctor:
- If you are allergic to Delzicol; 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 Delzicol 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 Delzicol?
- Tell all of your health care providers that you take Delzicol. 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 Delzicol.
- If you are 65 or older, use Delzicol 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.
- You may see parts of Delzicol in your stool. If this happens a lot, talk with your doctor.
- 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 Delzicol best taken?
Use Delzicol 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 Delzicol whole, you may open the capsules and swallow the contents. Be sure to swallow the contents and that none stay in your mouth. Swallow the contents whole. Do not chew, break, or crush.
- Keep taking Delzicol 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 Delzicol 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 Delzicol 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 Delzicol. 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 Delzicol. 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 Delzicol?
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.
- Nose or throat irritation.
- Back pain.
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 Delzicol?
- 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.
PRINCIPAL DISPLAY PANEL
- NDC 0023-5853-18
SRC: NLM .