Balsalazide

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

Other drugs may interact with balsalazide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Balsalazide can be taken with or without food.

To make swallowing easier, you may open the balsalazide capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away. Do not save the mixture for later use. The yellow-orange medicine from the capsule may stain your teeth or tongue when you use this method.

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

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

You should not use this medicine if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure balsalazide is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• 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.

FDA pregnancy category B. Balsalazide is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether balsalazide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a 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.

Take balsalazide 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. Also, do not stop taking balsalazide without first checking with your doctor.

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

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.

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

Dosing

The dose of balsalazide 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 balsalazide. 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—Three 750-milligram (mg) capsules three times a day, for a total daily dose of 6750 mg 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—Three 750-mg balsalazide capsules three times a day for a total daily dose of 6750 mg for 8 weeks or one 750-mg balsalazide capsule three times a day for a total daily dose of 2250 mg 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 two 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 balsalazide, 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month rat (Sprague Dawley) carcinogenicity study, oral (dietary) Balsalazide disodium at doses up to 2 g/kg/day was not tumorigenic. For a 50-kg person of average height this dose represents 2.4 times the recommended human dose on a body surface area basis. Balsalazide disodium was not genotoxic in the following in vitro or in vivo tests: Ames test, human lymphocyte chromosomal aberration test, and mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or mouse micronucleus test. However, it was genotoxic in the in vitro Chinese hamster lung cell (CH V79/HGPRT) forward mutation test.

4-aminobenzoyl-β-alanine, a metabolite of Balsalazide disodium, was not genotoxic in the Ames test and the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test but was positive in the human lymphocyte chromosomal aberration test. N-acetyl-4-aminobenzoyl-β-alanine, a conjugated metabolite of Balsalazide disodium, was not genotoxic in Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or the human lymphocyte chromosomal aberration test. Balsalazide disodium at oral doses up to 2 g/kg/day, 2.4 times the recommended human dose based on body surface area, was found to have no effect on fertility and reproductive performance in rats.

Animal Toxicology

Renal Toxicity
In animal studies conducted at doses up to 2000 mg/kg (approximately 21 times the recommended 6.75 g/day dose on a mg/kg basis for a 70 kg person), Balsalazide demonstrated no nephrotoxic effects in rats or dogs.

Overdosage
A single oral dose of Balsalazide disodium at 5 g/kg or 4-aminobenzoyl-β-alanine, a metabolite of Balsalazide disodium, at 1 g/kg was non-lethal in mice and rats. No symptoms of acute toxicity were seen at these doses.

Adult Studies

Two randomized, double-blind studies were conducted in adults. In the first trial, 103 patients with active mild-to-moderate ulcerative colitis with sigmoidoscopy findings of friable or spontaneously bleeding mucosa were randomized and treated with Balsalazide 6.75 g/day or Balsalazide 2.25 g/day. The primary efficacy endpoint was reduction of rectal bleeding and improvement of at least one of the other assessed symptoms (stool frequency, patient functional assessment, abdominal pain, sigmoidoscopic grade, and physician’s global assessment [PGA]). Outcome assessment for rectal bleeding at each interim period (week 2, 4, and 8) encompassed a 4-day period (96 hours).  Results demonstrated a statistically significant difference between high and low doses of Balsalazide (Figure 1).

Figure 1: Percentage of Patients Improved at 8 weeks

A second study, conducted in Europe, confirmed findings of symptomatic improvement.

Pediatric Studies

A clinical trial was conducted comparing two doses (6.75 g/day and 2.25 g/day) of Balsalazide disodium in 68 pediatric patients (age 5 to 17, 23 males and 45 females) with mildly to moderately active ulcerative colitis. 28/33 (85%) patients randomized to 6.75 g/day and 25/35 (71%) patients randomized to 2.25 g/day completed the study. The primary endpoint for this study was the proportion of subjects with clinical improvement (defined as a reduction of at least 3 points in the Modified Sutherland Ulcerative Colitis Activity Index [MUCAI] from baseline to 8 weeks). Fifteen (45%) patients in the Balsalazide disodium 6.75 g/day group and 13 (37%) patients in the Balsalazide disodium 2.25 g/day group showed this clinical improvement. In both groups, patients with higher MUCAI total scores at baseline were likely to experience greater improvement.

Rectal bleeding improved in 64% of patients treated with Balsalazide disodium 6.75 g/day and 54% of patients treated with Balsalazide disodium 2.25 g/day. Colonic mucosal appearance upon endoscopy improved in 61% of patients treated with Balsalazide disodium 6.75 g/day and 46% of patients treated with Balsalazide disodium 2.25 g/day.

(bal SAL a zide)

• 5-Aminosalicylic Acid Derivative
• Anti-inflammatory Agent

Ulcerative colitis: May have increased AUC.

Ulcerative colitis: Oral:

Capsule: 2.25 g 3 times daily for 8 to 12 weeks

Tablet: Males: 3.3 g twice daily for up to 8 weeks

Ulcerative colitis, remission maintenance (off-label): 1.5 or 3 g twice daily for 6 to 12 months (Ford 2011)

Refer to adult dosing.

Improvement or worsening of symptoms; renal function (baseline, within first 6 months of initiation, then annually thereafter) (Hanauer 2008); liver function tests (in patients with liver disease)

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Your pharmacist can provide more information about balsalazide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Copyright 1996-2013 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

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