Balsalazide Disodium

BALSALAZIDE DISODIUM- balsalazide disodium capsule
Mylan Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in adults. Safety and effectiveness of balsalazide disodium beyond 12 weeks in adults have not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Dose

For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg balsalazide disodium capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.

2.3 Administration Alternatives

Balsalazide disodium capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of balsalazide disodium capsules are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.

If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.

Teeth and/or tongue staining may occur in some patients who use balsalazide in sprinkle form with food.

3 DOSAGE FORMS AND STRENGTHS

Balsalazide disodium capsules are available as a 750 mg capsules with an orange opaque cap/orange opaque body, hard-shell gelatin capsule filled with orange to yellow powder. The capsule is axially printed with MYLAN over 6750 in black ink on both the cap and body.

4 CONTRAINDICATIONS

Patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.

5 WARNINGS AND PRECAUTIONS

5.1 Exacerbations of Ulcerative Colitis

In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis.

Observe patients closely for worsening of these symptoms while on treatment.

5.2 Pyloric Stenosis

Patients with pyloric stenosis may have prolonged gastric retention of balsalazide disodium capsules.

5.3 Renal

Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering balsalazide disodium to patients with known renal dysfunction or a history of renal disease. [See Nonclinical Toxicology (13.2)]

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

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 the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Ulcerative Colitis

During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day balsalazide disodium in four controlled trials.

In the four controlled clinical trials patients receiving a balsalazide disodium dose of 6.75 g/day most frequently reported the following adverse reactions: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable among patients on balsalazide and placebo.

Adverse reactions reported by 1% or more of patients who participated in the four well controlled, Phase 3 trials are presented by treatment group in Table 1.

The number of placebo patients (35), however, is too small for valid comparisons. Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

Table 1: Adverse Reactions Occurring in ≥ 1% of Adult Balsalazide Patients in Controlled Trials *
*
Adverse reactions occurring in at least 1% of balsalazide patients which were less frequent than placebo for the same event were not included in the table.

Adverse Reaction

Balsalazide 6.75 g/ day

[N = 259]

Placebo

[N = 35]

Abdominal pain

16 (6%)

1 (3%)

Diarrhea

14 (5%)

1 (3%)

Arthralgia

9 (4%)

0%

Rhinitis

6 (2%)

0%

Insomnia

6 (2%)

0%

Fatigue

6 (2%)

0%

Flatulence

5 (2%)

0%

Fever

5 (2%)

0%

Dyspepsia

5 (2%)

0%

Pharyngitis

4 (2%)

0%

Coughing

4 (2%)

0%

Anorexia

4 (2%)

0%

Urinary tract infection

3 (1%)

0%

Myalgia

3 (1%)

0%

Flu-like disorder

3 (1%)

0%

Dry mouth

3 (1%)

0%

Cramps

3 (1%)

0%

Constipation

3 (1%)

0%

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