Uses for Colazal

Balsalazide is used to treat an inflammatory bowel disease called ulcerative colitis. Balsalazide capsules are used to treat mild to moderately active ulcerative colitis in patients 5 years of age and older. Balsalazide tablets are used to treat mild to moderately active ulcerative colitis in male patients 18 years of age and older.

Balsalazide works inside the bowels to reduce the inflammation and other symptoms of the disease.

This medicine is available only with your doctor's prescription.

Before using Colazal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of balsalazide capsules in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of balsalazide tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of balsalazide in the elderly. However, elderly patients are more likely to have blood problems (eg, neutropenia, pancytopenia) and age-related kidney, liver, or heart disease, which may require caution and an adjustment in the dose for patients receiving balsalazide.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bismuth Subsalicylate
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Ibuprofen
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mesalamine
• Methotrexate
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olsalazine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trolamine Salicylate
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tamarind
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aminosalicylates or salicylates (eg, aspirin)—Should not be used in patients with this condition.

• Allergy to sulfasalazine (Azulfidine®) or
• Skin problems (eg, atopic dermatitis, atopic eczema)—Use with caution. May cause side effects to become worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Heart disease or
• Liver disease—Use with caution. May make these conditions worse.

• Pyloric stenosis (tube is too narrow where food passes out of the stomach )—May delay the release of balsalazide into the body.

Proper use of Colazal

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine without first checking with your doctor.

You may take this medicine with or without food. Also, tell your doctor if you are on a low-sodium diet.

Swallow the capsule whole. Do not cut, break, crush, or chew it.

If you cannot swallow the capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow right away. Do not keep the mixture for future use. This mixture may stain your teeth or tongue. Talk with your doctor if you have any concerns about this.

Do not change to another brand without checking with your doctor. The number of capsules or tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Drink extra fluids so you will urinate more often and help prevent kidney problems (eg, kidney stones).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of ulcerative colitis:
  • For oral dosage form (capsules):
    • Adults—2.25 grams (g) (3 capsules) 3 times a day for 8 weeks. You may need to take the medicine for up to 12 weeks as ordered by your doctor.
    • Children 5 years of age and older—2.25 g (3 capsules) 3 times a day for 8 weeks or 750 milligrams (mg) (1 capsule) 3 times a day for 8 weeks.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults—Three 1.1-gram (g) tablets 2 times a day, for a total daily dose of 6.6 g, taken for up to 8 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Colazal

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.

If your symptoms do not improve or if they become worse, check with your doctor.

This medicine may cause serious kidney problems, including kidney stones. Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, loss of appetite, nausea, vomiting, unusual tiredness or weakness, swelling of the face, fingers, or lower legs, weight gain, or trouble breathing.

Check with your doctor right away if you have stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you more sensitive to light and cause serious unwanted skin reaction. This is more likely if you have an existing skin problem (eg, atopic dermatitis, atopic eczema). Check with your doctor right away if you have increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using mesalamine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of Colazal

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Agitation
• bloody diarrhea
• blood in the urine
• coma
• confusion
• dark-colored urine
• decreased urine output
• depression
• dizziness
• fever
• headache
• hostility
• increased sensitivity of the skin to sunlight
• irritability
• itching, skin rash
• lethargy
• light-colored stools
• muscle twitching
• nausea
• pain in the groin or genitals
• rapid weight gain
• redness or other discoloration of the skin
• seizures
• severe sunburn
• sharp back pain just below ribs
• stomach pain
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common

• Bladder pain
• cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• heavy bleeding
• lower back or side pain
• pale skin
• trouble breathing
• unusual bleeding or bruising

Rare

• Chest tightness

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• chest pain
• chills
• clay colored stools
• cough
• decreased appetite
• dizziness
• increased blood pressure
• increased thirst
• joint or muscle pain
• loss of appetite
• red, irritated eyes
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the ,fingers, feet, or lower legs
• unpleasant breath odor
• vomiting of blood
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• muscle aches
• sore throat
• stuffy or runny nose

Less common

• Acid or sour stomach
• belching
• bloated or full feeling
• body aches or pain
• bone pain
• congestion
• constipation
• coughing
• cramps
• difficulty with moving
• dry mouth
• dryness of the throat
• excess air or gas in the stomach or bowels
• general feeling of discomfort or illness
• heartburn
• hoarseness
• indigestion
• muscle stiffness
• passing of gas
• shivering
• sleeplessness
• sneezing
• stomach discomfort or upset
• sweating
• swelling or inflammation of the mouth
• swollen joints
• tender, swollen glands in the neck
• trouble with sleeping
• trouble with swallowing
• unable to sleep
• voice changes
• weight loss

Rare

• Back pain
• ear congestion
• loss of voice
• pain in the ankles or knees
• painful, red lumps under the skin, mostly on the legs
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

• Loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.