The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

Colazal side effects

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

Colazal may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;
• worsening colitis symptoms–fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems–little or no urinating, swelling, rapid weight gain;
• liver problems–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Colazal may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Colazal if you are allergic to Colazal or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Colazal tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Colazal will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Colazal capsules should not be given to a child younger than 5 years old. This medicine tablets should not be given to anyone under 18 years old.

How should I take Colazal?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Colazal can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

Call your doctor if your symptoms do not improve, or if they get worse.

Colazal is usually taken only for a short time (8 to 12 weeks). Follow your doctor’s dosing instructions very carefully.

Canasa (mesalamine) is a suppository used to treat a type of inflammatory bowel disease called ulcerative proctitis. Ulcerative proctitis causes inflammation, redness and ulcers to develop in the lining of the rectum, which is at the end of your large intestine. Ulcerative proctitis may also affect nearby parts of the colon.

Canasa contains the medication mesalamine, which is also known as mesalazine or 5-aminosalicylic acid (5-ASA). It is contained inside a base of hard fat. Canasa is used topically and is inserted into the rectum. As the warmth of your body melts the hard fat base, the drug is released into the area where it needs to work.

Canasa belongs to a class of drugs called aminosalicylates. Canasa is thought to work by reducing inflammation in the epithelial cells that line the colon. Its anti-inflammatory action may result from its ability to block the enzyme cyclooxygenase (COX) and inhibit prostaglandin production in the colon. COX and prostaglandins (a group of lipids) are both involved in generating an inflammatory response.

Medications containing mesalamine have been available for many years, however, Canasa was first approved by the US Food and Drug Administration (FDA) in 2001.

When Canasa was first approved it was available as a 500 mg strength suppository that needed to be used twice a day. This has been replaced by a 1000 mg strength suppository that only needs to be used at night. Generic versions of Canasa are also available.

What is Canasa used for?

Canasa is a prescription medicine used to treat adults with active ulcerative proctitis (ulcerative rectal colitis).

It is not known if Canasa is safe and effective in children.

Important information

Canasa is for rectal use only. Do not take Canasa by mouth.

Who should not use Canasa?

Do not use Canasa if your are:

• allergic to medicines that contain salicylates, including aspirin.
• allergic to mesalamine or any of the ingredients in Canasa. See below for a complete list of ingredients in Canasa.

Ask your doctor if you are not sure if your medicine is listed above.

What should I tell my doctor before using Canasa?

Before using Canasa, tell your doctor if you have any medical conditions, including if you:

• have a history of allergic reaction to the medicine sulfasalazine (Azulfidine).
• have kidney problems.
• have ever had inflammation of the sac around your heart (pericarditis).
• have liver problems.

How should I use Canasa?

• Use Canasa exactly as prescribed by your doctor. Your doctor will tell you how long to continue using Canasa.
• Canasa comes as a suppository that you insert into your rectum.
• Do not cut or break the suppository.
• Use Canasa 1 time each day at bedtime, for 3 to 6 weeks. It is not known if Canasa is safe and effective for use for longer than 6 weeks.
• After you insert Canasa in your rectum, try to keep (retain) the suppository in your rectum for 1 to 3 hours or longer if possible.
• It is important for you to stay well hydrated during treatment with Canasa. Be sure to drink plenty of fluids while taking Canasa.

What happens if I miss a dose?

If you miss a dose of Canasa, insert it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Insert the next dose at your regular time. Do not insert 2 doses at the same time.

What should I avoid while using Canasa?

Canasa can stain surfaces including clothing and other fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. Keep Canasa away from these surfaces to prevent staining.

If you have atopic dermatitis or eczema you may become more sensitive to the sun while using Canasa. Avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

Dosing information

The recommended dose of Canasa for adults is 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks. Safety and effectiveness beyond 6 weeks have not been established.

See full prescribing information for more information about Canasa dosing.

What are the side effects of Canasa?

Canasa may cause serious side effects, including:

• kidney problems. Your doctor will do certain tests before you start using Canasa and during your treatment with Canasa.
• acute intolerance syndrome and other allergic reactions. Some people who use Canasa can have allergic type reactions, including Acute Intolerance Syndrome. Other allergic reactions can cause heart problems including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body including the kidneys, liver and lungs. These problems usually happen in people who have had an allergic reaction to medicines containing sulfasalazine. Stop using Canasa and tell your doctor right away if you get any of these symptoms:
  • cramps
  • fever
  • stomach (abdominal) pain
  • headache
  • bloody diarrhea
  • rash
  • chest pain
  • shortness of breath
  • decrease in the amount of urine
  • fatigue
  • eye inflammation
• liver problems. This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your doctor right away if you get any of these symptoms while using Canasa:
  • yellowing of your eyes
  • flu-like symptoms
  • itchy skin
  • nausea or vomiting
  • feeling very tired
• serious skin reactions. Some people who use Canasa can have severe skin reactions. Stop using Canasa and tell your doctor right away if you develop any of the following signs or symptoms of a severe skin reaction, including:
  • blisters or peeling of your skin
  • mouth sores
  • blisters on your lips, or around your mouth or eyes
  • high fever or flu-like symptoms
  • enlarged lymph nodes
  • skin rash
• sun sensitivity. Canasa can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. Try to limit your time in the sun. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight.
• kidney stones. Drink plenty of fluids when using Canasa to decrease your chance of getting kidney stones. Call your doctor right away if you get any of these symptoms:
  • severe pain in your side
  • severe pain in your back
  • blood in your urine

The most common side effects of Canasa include:

• dizziness
• rectal pain
• acne
• fever
• inflammation of the large intestine (colitis)
• rash

These are not all of the possible side effects of Canasa.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Using Canasa with certain other medicines may affect each other. Using Canasa with other medicines can cause serious side effects.

Especially tell your doctor if you take nonsteroidal anti-inflammatory drugs (NSAIDS), or medicines that contain azathioprine or 6-mercaptopurine. Taking Canasa with NSAIDS may cause kidney problems. Taking Canasa with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor may do certain tests during treatment with Canasa.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Canasa can harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. Canasa can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you use Canasa.

Storage

• Store Canasa at room temperature between 68°F to 77°F (20°C to 25°C).
• Canasa may be refrigerated.
• Keep Canasa away from direct heat, light, or humidity.

Keep Canasa and all medicines out of the reach of children.

What are the ingredients in Canasa?

Active ingredients: mesalamine

Inactive ingredients: hard fat base

Canasa is distributed by Allergan USA, Inc. Madison, NJ 07940.

The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

Balsalazide side effects

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

Balsalazide may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;
• worsening colitis symptoms–fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems–little or no urinating, swelling, rapid weight gain;
• liver problems–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of balsalazide may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use balsalazide if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Balsalazide capsules should not be given to a child younger than 5 years old. Balsalazide tablets should not be given to anyone under 18 years old.

How should I take balsalazide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Balsalazide can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

Call your doctor if your symptoms do not improve, or if they get worse.

Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor’s dosing instructions very carefully.

Store at room temperature away from moisture and heat.

Balsalazide dosing information

Usual Adult Dose for Ulcerative Colitis — Active:

Oral capsules:
Usual dose: Three 750 mg capsules orally 3 times a day for up to 8 weeks
-Some patients in the clinical trials required up to 12 weeks of treatment.
-Safety and efficacy beyond 12 weeks have not been established.

GIAZO(R) tablets; male patients:
Three 1.1 gram tablets orally twice a day, with or without food, for up to 8 weeks
-Effectiveness in female patients was not demonstrated in clinical trials.
-Safety and efficacy beyond 8 weeks have not been established.

Use(s): Treatment of mildly to moderately active ulcerative colitis.

Usual Pediatric Dose for Ulcerative Colitis — Active:

5 years and older, oral capsules:
Three 750 mg capsules orally 3 times a day for up to 8 weeks
OR
One 750 mg capsule orally 3 times a day for up to 8 weeks

Comments:
-Safety and efficacy beyond 8 weeks have not been established

Use(s): Treatment of mildly to moderately active ulcerative colitis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking balsalazide?

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

What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

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

Azulfidine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• fever with headache, rash, and vomiting;
• a skin rash, no matter how mild;
• severe nausea or vomiting when you first start taking Azulfidine;
• little or no urination, urine that looks foamy;
• puffy eyes, swelling in your ankles or feet, weight gain; or
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Azulfidine may include:

• nausea, vomiting, upset stomach, loss of appetite;
• headache;
• rash; or
• low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

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

• a blockage in your bladder or intestines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to sulfa drugs; or
• an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• frequent infections;
• asthma;
• low blood cell counts; or
• liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

Azulfidine is not approved for use by anyone younger than 2 years old.

How should I take Azulfidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Azulfidine after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

What is Giazo?

The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

Giazo side effects

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

Giazo may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;
• worsening colitis symptoms–fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems–little or no urinating, swelling, rapid weight gain;
• liver problems–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Giazo may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Giazo if you are allergic to Giazo or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Giazo tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Giazo will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Giazo capsules should not be given to a child younger than 5 years old. This medicine tablets should not be given to anyone under 18 years old.

How should I take Giazo?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Giazo can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

Call your doctor if your symptoms do not improve, or if they get worse.

Giazo is usually taken only for a short time (8 to 12 weeks). Follow your doctor’s dosing instructions very carefully.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help.

What should I avoid while taking Giazo?

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

What is Lialda?

Lialda affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Lialda is used to treat mild to moderate active ulcerative colitis in adults and children who weight at least 24kg.

Lialda is also used in adults as a maintenance treatment to prevent the symptoms of ulcerative colitis from recurring.

Warnings

Stop using Lialda and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

Before taking this medicine

You should not use Lialda if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure Lialda is safe for you, tell your doctor if you have ever had:

• a kidney stone or kidney disease;
• liver disease;
• a blockage in your stomach or intestines (such as pyloric stenosis); or
• a skin condition such as eczema.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

It may not be safe to breastfeed while using Lialda. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

How should I take Lialda?

Take Lialda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Lialda.

Lialda should be taken with a meal.

Drink plenty of liquids to help prevent kidney stones.

Swallow the Lialda tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the tablet.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Lialda.

You may need frequent blood tests to check your blood cells or kidney function.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Lialda for Ulcerative Colitis — Active:

1200 mg tablets: 2.4 to 4.8 g (two to four tablets) orally once a day with food.

Usual Adult Dose of Lialda for Ulcerative Colitis — Maintenance:

1200 mg tablets: 2.4 g (two tablets) orally once a day with food.

Usual Pediatric Dose of Lialda for Ulcerative Colitis — Active:

Patient weight – 24 kg to 35 kg: from week 0 to week 8, two 1.2 g tablets once daily. After week 8, one 1.2 g tablet once daily.
Greater than 35 kg to 50 kg: from week 0 to week 8, three 1.2 g tablets once daily. After week 8, two 1.2 g tablets once daily.
Greater than 50 kg: from week 0 to week 8, four 1.2 g tablets once daily. After week 8, two 1.2 g tablets once daily.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Lialda?

If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Lialda side effects

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

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

• severe stomach pain, stomach cramping, bloody diarrhea;
• fever, headache, general ill feeling;
• rash, itching, eye redness;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
• signs of a kidney stone – severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
• kidney problems – increased or decreased urination, swelling, weight gain; or
• liver problems – loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common Lialda side effects may include:

• burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
• dizziness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• back pain;
• headache;
• rash; or
• abnormal liver function tests.

What is mesalamine?

Mesalamine is used to treat mild to moderate ulcerative colitis and prevent the symptoms of ulcerative colitis from recurring. Mesalamine is a long-term treatment that relieves inflammation and may be one of the first treatment options considered for ulcerative colitis. Mesalamine does not suppress the immune system and is not an immunosuppressant.

Mesalamine, also known as 5-ASA (5-aminosalicylic acid), is an aminosalicylic acid chemically related to aspirin. The exact mechanism of action for mesalamine in ulcerative colitis is not known, but it is thought to reduce inflammation by modulating the response of the cyclooxygenase and lipooxygenase pathways, reducing the production of prostaglandins and leukotrienes.

Some brands of mesalamine are for use only in adults, and some brands are for use in children who are at least 5 years old, for example, the delayed-release (Asacol HD) is for adults, but another brand, Lialda, may be used in adults and children who weigh at least 53 to 77 pounds (24 to 35 kg). Mesalamine capsules and tablets are taken by mouth (orally) and rectal mesalamine preparations (such as Canasa suppositories or Rowasa enemas) are inserted directly into the lowest part of the bowel to relieve inflammation associated with conditions such as distal ulcerative colitis, proctosigmoiditis, and proctitis.

Mesalamine first gained FDA approval in December 1987 as sfRowasa and Rowasa enemas. Asacol delayed-release tablets were the first oral preparation approved on January 31, 1992. Brand names for mesalamine include Lialda, Pentasa, Apriso, and Delzicol.

Mesalamine side effects

Common side effects of mesalamine may include:

• burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
• dizziness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• back pain;
• headache;
• rash; or
• abnormal liver function tests.

Serious side effects and warnings

Mesalamine may cause hypersensitivity reactions, including anaphylaxis. Should not be taken by people with a known or suspected hypersensitivity to salicylates or aminosalicylates, mesalamine, or any of the inactive ingredients in the preparations. Some hypersensitivity reactions may present with heart inflammation, such as myocarditis and pericarditis. Stop taking mesalamine and call your healthcare provider right away if you have signs of an allergic reaction such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Kidney problems have been reported in people taking mesalamine or products that are converted to mesalamine. Your healthcare provider will monitor your kidney function before starting treatment and then regularly thereafter. Mesalamine may not be suitable for people with pre-existing kidney disease or who are also taking other medications that can affect kidney function.

Mesalamine has been associated with an acute intolerance syndrome (AIS) that may be difficult to distinguish from an exacerbation of ulcerative colitis. Tell your healthcare provider if your symptoms worsen while on treatment, stop treatment, or if you suspect AIS.

May not be suitable for people with liver disease.

May cause blood disorders, and seniors or those taking other medicines, such as azathioprine or 6-mercaptopurine, are more at risk. Your healthcare provider will monitor you for these.

Do not give this medicine to a child without medical advice. Some brands of mesalamine are not approved for use in anyone younger than 18 years old. Delzicol should not be given to a child younger than 5 years old.

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

• severe stomach pain, stomach cramping, bloody diarrhea;
• fever, headache, general ill feeling;
• rash, itching, eye redness;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• low white blood cell counts–fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
• signs of a kidney stone–severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
• kidney problems–increased or decreased urination, swelling, weight gain; or
• liver problems–loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

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 the FDA .

Mesalamine cost

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of mesalamine.

You may also be eligible for a mesalamine coupon, or mesalamine copay card. Ask your doctor or pharmacist if you qualify. Brand names for mesalamine include Lialda, Pentasa, Apriso, and Delzicol.

Before taking this medicine

You should not use mesalamine if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• a kidney stone or kidney disease
• liver disease
• a blockage in your stomach or intestines (such as pyloric stenosis) or
• a skin condition such as eczema
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Some forms of mesalamine contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

How should I take mesalamine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.
• This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine.
• You may need frequent blood tests to check your blood cells or kidney function.

Oral mesalamine

Read the label on the container. Some mesalamine preparations are taken with food and others are taken on an empty stomach. For example:

• Asacol HD is taken on an empty stomach, at least 1 hour before or 2 hours after a meal
• Lialda should be taken with a meal
• You may take Apriso with or without food

Drink plenty of liquids to help prevent kidney stones.

Swallow the capsule or tablet whole and do not crush, chew, or break it. Tell your doctor if you have trouble swallowing the pill.

• If you cannot swallow a Pentasa capsule whole, open it and sprinkle the medicine into a spoonful of yogurt or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Tell your doctor if you find undissolved mesalamine tablets in your stool.

Rectal mesalamine

The usual dosage of mesalamine rectal suppositories in adults is 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

• Using mesalamine rectal suppositories beyond 6 weeks have not been established.
• Do not cut or break mesalamine suppositories. Retain the suppository for one to three hours or longer, if possible.
• Drink an adequate amount of fluids.
• Mesalamine rectal suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel, and should be kept away from these surfces to prevent staining.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking mesalamine?

If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb mesalamine.

What is Pentasa?

Pentasa affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Pentasa is used to treat mild to moderate ulcerative colitis in adults. Ucerative colitis is associated with inflammation, ulcers and sores in the bowel causing bleeding, stomach pain, and diarrhoea.

Pentasa is also used off-label in the USA as a treatment for Crohn’s disease. Use of Pentasa to treat Crohn’s disease is officially approved in some other countries.

Warnings

Stop using Pentasa and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

Before taking this medicine

You should not use Pentasa if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure Pentasa is safe for you, tell your doctor if you have ever had:

• a kidney stone or kidney disease;
• liver disease;
• a blockage in your stomach or intestines (such as pyloric stenosis); or
• a skin condition such as eczema.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Do not give this medicine to a child without medical advice.

How should I take Pentasa?

Take Pentasa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine.

Drink plenty of liquids to help prevent kidney stones.

Pentasa can be taken with or without food.

Swallow the capsule whole and do not chew or crush the contents of the capsule. Tell your doctor if you have trouble swallowing the capsule.

If you cannot swallow a Pentasa capsule whole, open it and sprinkle the medicine into a spoonful of yogurt or applesauce. Swallow all of the mixture immediately without chewing. Do not save it for later use.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine.

You may need frequent blood tests to check your blood cells or kidney function.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Ulcerative Colitis — Active:

250 and 500 mg extended-release capsules: 1 g orally 4 times a day
Duration of therapy: Up to 8 weeks.

Uses: Treatment of mildly to moderately active ulcerative colitis and induction of remission of ulcerative colitis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Pentasa?

If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Pentasa side effects

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

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

• severe stomach pain, stomach cramping, bloody diarrhea;
• fever, headache, general ill feeling;
• rash, itching, eye redness;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• low white blood cell counts – fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
• signs of a kidney stone – severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;
• kidney problems – increased or decreased urination, swelling, weight gain; or
• liver problems – loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common Pentasa side effects may include:

• burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;
• dizziness;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• back pain;
• headache;
• rash; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Pentasa?

Mesalamine can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• azathioprine or 6-mercaptopurine.

What is Rowasa?

Rowasa (mesalamine, sfRowasa) is an enema used in the treatment of inflammatory bowel disease including ulcerative colitis, proctosigmoiditis and proctitis. It is a liquid suspension for topical use that you instill into your rectum using a small bottle with an applicator tip.

Rowasa contains the drug mesalamine, which is also known as mesalazine or 5-aminosalicylic acid (5-ASA). It belongs to a class of drugs called aminosalicylates.

Rowasa is thought to work by blocking the enzyme cyclooxygenase (COX) and inhibiting prostaglandin production in the colon, which helps to reduce inflammation. COX and prostaglandins (a group of lipids) are both involved in generating an inflammatory response. Rowasa is thought to work locally to reduce inflammation in the epithelial cells that line the colon.

Rowasa was the first mesalamine product to be approved by the US Food and Drug Administration (FDA) for ulcerative colitis when it was approved in 1987.

Rowasa contains a sulfite called potassium metabisulfite, which some people are sensitive too, particularly people who have asthma or other atopic conditions. A sulfite-free Rowasa enema called sfRowasa is also available.

What is Rowasa used for?

Rowasa is a prescription medication used to treat active mild-to-moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Important information

Rowasa is for rectal use only. Do not take Rowasa by mouth.

Who should not use Rowasa?

Do not use Rowasa, including sfRowasa, if you are, or suspect you are, hypersensitive to salicylates, aminosalicylates, sulfites or any other component of this medication.

What should I tell my doctor before using Rowasa?

Before using Rowasa, tell your doctor if you have any medical conditions, including if you:

• have kidney problems
• have liver problems
• have a history of allergic reaction to the medicine sulfasalazine (Azulfidine)

How should I use Rowasa?

• Use Rowasa exactly as prescribed by your doctor.
• It is important for you to stay well hydrated during treatment with Rowasa. Be sure to drink plenty of fluids while taking Rowasa.
• The recommended dose of Rowasa is one bottle (4 grams) instilled once daily at bedtime for 3 to 6 weeks. Your doctor will tell you what dose is right for you.
• Empty your bowels before instilling Rowasa if possible.
• Remove the Rowasa bottles from their protective foil pouch by tearing the pouch or using scissors. Take care not to squeeze or puncture the bottles.
  • Rowasa suspension is an off-white to tan color. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect how Rowasa works, however, enemas with dark brown contents should be discarded.
• To prepare Rowasa
  • Shake the bottle well to make sure the suspension is thoroughly mixed.
  • Remove the protective sheath from the applicator tip. Hold the bottle at the neck the suspension does not come out.
• Position yourself in the correct body position to administer Rowasa.
  • Lie down on your left side with your left leg extended and your right leg flexed forward for balance.
  • Alternatively you can put both knees on the ground and fold the top half of your body over so that your head is on the ground, your knees are close to your chest and your bottom is in the air.
• Administer Rowasa
  • Gently insert the lubricated applicator tip into your rectum to prevent damage to the rectal wall. Point the applicator tip slightly towards your navel.
  • Grasp the bottle firmly, then tilt it slightly so that the nozzle is aimed towards your back. Squeeze the bottle slowly to instill the medication. Apply steady hand pressure to squeeze the medication out of the bottle.
• After administering, withdraw the applicator tip and attached bottle and discard.
• Remain in position for at least 30 minutes to allow Rowasa to spread internally. Retain the medication all night, if possible.

What happens if I miss a dose?

If you miss a dose of Rowasa, instill it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Instill the next dose at your regular time. Do not insert 2 doses at the same time.

What should I avoid while using Rowasa?

Rowasa can stain surfaces including fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. Keep Rowasa away from these surfaces to prevent staining.

If you have atopic dermatitis or eczema you may become more sensitive to the sun while using Rowasa. Avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

Dosing information

The recommended adult dosage of Rowasa in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. The usual course of therapy is from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

See full prescribing information for further information about Rowasa dosing.

What are the side effects of Rowasa?

Most side effects of Rowasa are mild and transient.

Side effects of Rowasa include:

• Abdominal pain, cramps or discomfort
• Headache
• Gas or flatulence
• Nausea
• Flu
• Tiredness, weakness, malaise or fatigue
• Fever
• Rash or spots
• A cold or sore throat
• Diarrhea
• Leg or joint pain
• Dizziness
• Bloating
• Back pain
• Pain on insertion of enema tip
• Hemorrhoids
• Itching
• Rectal pain
• Constipation
• Hair loss
• Peripheral edema
• Urinary tract infection or urinary burning
• Rectal pain soreness or burning
• Asthenia
• Insomnia

Products containing the active ingredient mesalamine have been reported to cause:

• Kidney problems, including kidney stones
• Acute intolerance syndrome and other allergic reactions
• Liver problems
• Severe skin reactions
• Sun sensitivity

These are not all of the possible side effects of Rowasa.

Call your doctor for medical advice about side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Using Rowasa with certain other medicines may affect each other. Using Rowasa with other medicines can cause serious side effects.

Especially tell your doctor if you take nonsteroidal anti-inflammatory drugs (NSAIDS), or medicines that contain azathioprine or 6-mercaptopurine. Taking Rowasa with NSAIDS may cause kidney problems. Taking Rowasa with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor may do certain tests during treatment with Rowasa.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Rowasa can harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. Rowasa can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you use Rowasa.

Storage

• Store Rowasa at 20° to 25°C (68° to 77°F).
• Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your doctor.
• Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

Keep out of reach of children.

What are the ingredients in Rowasa and sfRowasa?

Active ingredient: mesalamine

Inactive ingredients:

Rowasa: carbomer homopolymer type B (allyl pentaerythritol crosslinked), edetate disodium, potassium acetate, potassium metabisulfite, water, sodium benzoate, xanthan gum

sfRowasa: carbomer homopolymer type B (allyl pentaerythritol or allyl sucrose crosslinked), edetate disodium, potassium acetate, water, sodium benzoate, xanthan gum