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.

Oral budesonide is used to treat the following conditions with inflammation as a symptom:

• Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [budesonide oral suspension 2 mg/10 mL])
• Active, mild to moderate Crohn’s disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [budesonide extended-release capsules 3 mg, 6 mg, 9 mg])
• Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [budesonide extended-release tablets 9 mg])
• Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [budesonide delayed release capsules 4 mg])

Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids.

Budesonide is a potent anti-inflammatory corticosteroid, 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism).

Budesonide oral FDA approvals are as follows:

• Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic.
• Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available.
• Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]).  
• Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available.
• Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic. 

Budesonide side effects

The most common side effects of budesonide oral suspension (Eohilia) are:

• respiratory tract infection
• sore throat
• fungal infections of the mouth, throat, and esophagus (thrush)
• adrenal suppression
• headache
• acid-related damage to the lining of the esophagus (erosive esophagitis)
• infection of the stomach and intestine (gastroenteritis).

The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion 
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain.

The most common side effects of budesonide delayed-release capsules (Tarpeyo) are:

• swelling of the lower legs, ankles, and feet
• high blood pressure
• muscle spasms
• acne
• headache
• upper respiratory tract infection
• swelling of the face
• weight increase
• indigestion
• irritation or inflammation of the skin
• joint pain
•  increased white blood cell count

The most common side effects of budesonide extended release tablets (Uceris, generic) are:

• headache
• nausea
• decreased blood cortisol levels
• stomach-area pain
• tiredness
• stomach or intestinal gas
• bloating
• acne
• urinary tract infection
• joint pain
• constipation.

Serious side effects and warnings

Budesonide (oral) may cause the following serious side effects:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
  • acne
  • thicker body hair and facial hair
  • bruise easily
  • a fatty pad or hump between your shoulders (buffalo hump)
  • rounding of your face
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
  • ankle swelling.
• Adrenal suppression. Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
  • tiredness
  • nausea and vomiting
  • weakness
  • low blood pressure.
• Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also:
  • make current infections worse
  • increase the risk of infections spreading (disseminated)
  • increase the risk of making infections active again or making infections worse that have not been active (latent)
  • hide (mask) some signs of infection

These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as:

• • fever
  • cough
  • chills
  • pain
  • stomach area (abdominal) pain
  • feeling tired
  • aches 
  • nausea and vomiting
  • diarrhea.
• Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide.
• Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
• Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide.
• Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms.
• Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include
  • white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or
  • swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur.
• Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as:
  • heartburn
  • chest pain
  • trouble swallowing.
• Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide.
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide.
• Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

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

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

Before taking this medicine

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products.

Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you:

• have liver problems
• are planning to have surgery
• have chicken pox or measles, or have recently been near anyone with chicken pox or measles
• have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections
• parasitic infections, including threadworm (Strongyloides) infections
• herpes simplex infection of the eye (ocular herpes simplex)
• have or had tuberculosis
• have malaria of the brain (cerebral malaria)
• have an infection of the mouth, throat, or esophagus
• have diabetes or glaucoma, or have a family history of diabetes or glaucoma
• have cataracts
• have high blood pressure (hypertension)
• have low bone mineral density or osteoporosis
• have stomach ulcers
• have a weak immune system
• have unexplained diarrhea
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Pregnancy

Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.

Breastfeeding

It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.

The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

How you take budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension

Eohilia stick packs

See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.

• Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
• Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
• Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
• After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.

Do not mix Eohilia with food or liquid.

Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.

Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.

Budesonide extended-release capsules

Entocort EC extended-release capsules and generic

Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.

• Take Entocort EC 1 time each day in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:

1. Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2. Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
3. Carefully empty all of the granules inside the capsule on the applesauce.
4. Stir the granules with the applesauce.
5. Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
6. Do not save the applesauce and granules for later use.

Ortikos extended-release capsules

Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.

• Take Ortikos 1 time each day, in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

Budesonide extended-release tablets

Uceris extended-release tablets and generic

Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.

• Take Uceris 1 time each day in the morning with or without food.
• Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.

Budesonide delayed-release capsules

Tarpeyo delayed-release capsules

Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.

• Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
• Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.

Dosing information

The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension 2 mg/10 mL

Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.

• 2mg is contained in one Eohilia stick pack.

Budesonide extended-release capsules

Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 9 mg once daily for up to 8 weeks
• Repeat 8-week courses with recurring episodes of active disease
• Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.

Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 6 mg once daily for up to 3 months.
• Taper to complete cessation after 3 months.
• Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.

Budesonide delayed-release tablets 

Dosage for ulcerative colitis (Uceris, generic)

• 9 mg once daily in the morning with or without food for up to 8 weeks.

Budesonide delayed-release capsules

Dosage for the treatment of IgAN in adults (Tarpeyo)

• 16 mg once daily
• Take in the morning at least 1 hour before food.
• The recommended duration of therapy is 9 months.
• When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.

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.

If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I take too much budesonide?

If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking budesonide?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid receiving a “live” vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What other drugs will affect budesonide?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.

Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.

Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Keep all medicines out of the reach of children.

Ingredients

Eohilia ingredients

Active ingredient: budesonide

Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Entocort EC ingredients

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Ortikos ingredients

Active ingredient: budesonide

Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.

Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.

The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.

Uceris ingredients

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Tarpeyo ingredients

Active ingredient: budesonide

Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.

The capsules contain: hypromellose and titanium oxide (E171).

The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).

The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who makes budesonide?

Budesonide is made by various manufacturers.

Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.

Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.

• A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.

Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.

Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.

• A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.

Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.

CONTRAINDICATIONS The HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: •Known allergies to polyethylene glycol or other components of the kit •Gastrointestinal (GI) obstruction •Bowel perforation •Toxic colitis •Toxic megacolon Toxic megacolon (4)

Warnings and Precautions

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Warnings

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Precautions

PRECAUTIONS Neurologic (5.1)Gastrointestinal There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. (5.2) Renal Insufficiency Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. (5.3) Allergic Reaction Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). (5.4)Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

Adverse Reactions/Side Effects

ADVERSE REACTIONS Most common adverse reactions (< 3%) are abdominal pain/cramping, nausea,vomiting and headache (6)To report SUSPECTED ADVERSE REACTIONS, contact BraintreeLaboratories, Inc.

Drug Interactions

DRUG INTERACTIONS
Oral medication administered within one hour of the start of administrationof HalfLytely solution may be flushed from the GI tract and the medicationmay not be absorbed. (7)
Do not take the bisacodyl delayed release tablets within one hour of takingan antacid. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 10/2007
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.
1 Neurologic
2 Gastrointestina
3 Renal Insufficiency

4 Allergic Reaction
5 ADVERSE REACTIONS

Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions ( 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping. The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

Use In Specific Populations

8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients has not been established. 8.5 Geriatric Use Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

PREGNANCY

Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients has not been established

GERIATRIC USE

Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

Bisacodyl Description

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.
•Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.
Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax.
The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration
( 2)].
•HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 1 gram of flavoring ingredient (if applicable). Flavor Packs are available in Cherry, Lemon-Lime and Orange. This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless. The HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets [see Dosage and Administration
( 2)].

Bisacodyl – Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon. 12.2 Pharmacodynamics Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis. 12.3 Pharmacokinetics The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

MECHANISM OF ACTION

HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon

PHARMACODYNAMICS

Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

PHARMACOKINETICS

The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.

How is Bisacodyl supplied

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:
One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped “BRA”
One 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride, and 1 gram of flavoring ingredient (if applicable). After adding 2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.3 mmol/L of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium.
Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient. HalfLytely and
Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).
Storage: Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). The reconstituted HalfLytely solution, which may be refrigerated, should be used within 48 hours. Lemon-Lime HalfLytely and Bisacodyl Tablets

Storage and Handling

STORAGE AND HANDLING17
PATIENT COUNSELING INFORMATION17.4 FDA-Approved Patient Labeling * Sections or subsections omitted from the full prescribing information are not listed page 2 of 6 FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEHalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 DOSAGE AND ADMINISTRATIONThe recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy isas follows: Take two 5 mg bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) shouldbe added to the solution.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.
Cap the container. Shake to dissolve thepowder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10minutes. Drink all of the solution.3 DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped 223BRA224 One 2 liter HalfLytely bottle with powder for reconstitution4 CONTRAINDICATIONSThe HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or other components of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon5 WARNINGS AND PRECAUTIONS5.
1 NeurologicThere have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparationproducts in patients with no prior history of seizures.
The seizure cases were associated with severe vomiting, excessive beverageconsumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).
The neurologic abnormalities resolved withcorrection of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used withcaution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients withknown or suspected hyponatremia. Monitor baseline and post-colonoscopy.

LABORATORY TESTS

laboratory tests (sodium, potassium, calcium, creatinine,and BUN) in these patients.
5.2 GastrointestinalUse with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex andpatients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected,appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitisin patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectalbleeding, patients should be evaluated as soon as possible.
5.3 Renal InsufficiencyPatients with impaired water handling who experience severe vomiting should be closely monitored including measurement ofelectrolytes (sodium, potassium, calcium, BUN and creatinine).
5.4 Allergic ReactionHives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction. page 3 of 6 6 ADVERSE REACTIONS
6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of adrug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials,abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (< 3%) after the administrationof HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mgBisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs. 223 patients exposed to HalfLytelyand 20 mg bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age,46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of thecomparator group were similar.Table
1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mgbisacodyl vs. 20 mg bisacodyl tablets) in the controlled trial.Table 2: Percentage of Patients Reporting in their Diaries 223bothersome224 to 223severely distressing224 Symptoms in Controlled ClinicalHalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial1 Half Lytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Discomfort 14% 20% 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting,and overall discomfort.
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposure.Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based productswhich may represent allergic reactions.Gastrointestinal:There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole,and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters ofPEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patientswho developed diarrhea, vomiting and dysnatremia.Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior tocolonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl TabletsBowel Prep Kit has not been established. page 4 of 6 Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-basedcolon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [seeWarnings and Precautions (5.1)]
.7 DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tractand the medication may not be absorbed.Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and BisacodylTablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytelyand Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.
8.3 Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should beexercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.
8.4 Pediatric UseSafety and effectiveness in pediatric patients has not been established.
8.5 Geriatric UseOf the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 yearsof age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed betweengeriatric patients and younger patients, and other reported clinical experience has not identified differences in responses betweengeriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.11 DESCRIPTIONEach HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonateand potassium chloride for oral solution and bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350,sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl,delayed release tablets.Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped 223BRA224) contains5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.

INACTIVE INGREDIENT

Bisacodyl delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax. The bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution [see Dosage and Administration].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Bisacodyl
GENERIC: Bisacodyl
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 24236-199-30
STRENGTH:5 mg
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 5 mm
IMPRINT: 30
QTY: 400

Bentyl is used to treat functional bowel or irritable bowel syndrome.

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

Warnings

Many drugs can affect Bentyl. Tell your doctor about all your current medicines.

Before taking this medicine

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

• glaucoma;
• a bladder obstruction or other urination problems;
• a blockage in your digestive tract (stomach or intestines);
• severe ulcerative colitis;
• gastroesophageal reflux disease (GERD);
• a serious heart condition and active bleeding;
• myasthenia gravis; or
• if you are breastfeeding a baby.

Not approved for use by anyone younger than 18 years old. Bentyl should never be given to a child younger than 6 months old.

Tell your doctor if you have ever had:

• heart problems or high blood pressure;
• a stroke;
• ulcerative colitis;
• an ileostomy or colostomy;
• an enlarged prostate; or
• liver or kidney disease.

Older adults may be more sensitive to the effects of Bentyl.

Tell your doctor if you are pregnant.

Do not breastfeed.

How should I take Bentyl?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Bentyl oral is taken by mouth.

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Bentyl injection is given in a muscle if you are unable to take the medicine by mouth.

Call your doctor if your symptoms do not improve after 2 weeks.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose can cause nausea, vomiting, dilated pupils, weakness or loss of movement in any part of your body, trouble swallowing, fainting, or seizure (convulsions).

What should I avoid while taking Bentyl?

May cause dizziness or blurred vision. Avoid driving or hazardous activity until you know how Bentyl will affect you.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Bentyl can decrease sweating and you may be more prone to heat stroke. Tell your doctor if you have a fever while taking this medicine.

Avoid using an antacid. Antacids can make it harder for your body to absorb Bentyl oral.

Bentyl 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.

Call your doctor at once if you have:

• fast or slow heartbeats, pounding heartbeats or fluttering in your chest;
• confusion, agitation, hallucinations, unusual thoughts or behavior;
• problems with memory or speech;
• problems with balance or muscle movement;
• diarrhea, severe constipation, or worsening of bowel symptoms;
• trouble swallowing;
• bruising, swelling, or pain where a Bentyl injection was given; or
• dehydration –dizziness, confusion, feeling very thirsty, less urination or sweating.

Confusion and mood or behavior changes may be more likely in older adults.

Common side effects may include:

• drowsiness, dizziness, weakness, nervousness;
• blurred vision;
• dry mouth; or
• nausea.

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 Bentyl?

Using Bentyl with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect Bentyl, especially:

• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• glaucoma medication;
• heart medication;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

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.