Drug: Colazal

Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of COLAZAL (balsalazide) (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2- carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is: Molecular Weight: 437.32 Molecular Formula: C17H13N3O6Na2•2H2O Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents. Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.

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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 COLAZAL (balsalazide) in 4 controlled trials. In the 4 controlled clinical trials patients receiving a COLAZAL (balsalazide) 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 COLAZAL (balsalazide) and placebo. Adverse reactions reported by 1% or more of patients who participated in the four 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 Events occurring in ≥ 1% of Adult COLAZAL (balsalazide) Patients in Controlled Trials* Adverse Reaction COLAZAL 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% *Adverse events occurring in at least 1% of Colazal (balsalazide) patients which were less frequent than placebo for the same event were not included in the table. Pediatric Ulcerative Colitis In a clinical trial in 68 pediatric patients aged 5 to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day COLAZAL (balsalazide) for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%). [see Table 2] One patient who received COLAZAL (balsalazide) 6.75 g/day and 3 patients who received COLAZAL (balsalazide) 2.25 g/day discontinued treatment because of adverse reactions. In addition, 2 patients in each dose group discontinued because of a lack of efficacy. Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2. Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 3% of Patients in Either Treatment Group in a Controlled Study of 68 Pediatric Patients Adverse Reaction COLAZAL 6.75 g/day
[N=33] 2.25 g/day
[N=35] Total
[N=68] Headache 5 (15%) 5 (14%) 10 (15%) Abdominal pain upper 3 (9%) 6 (17%) 9 (13%) Abdominal pain 4 (12%) 4 (11%) 8 (12%) Vomiting 1 (3%) 6 (17%) 7 (10%) Diarrhea 2 (6%) 4 (11%) 6 (9%) Colitis ulcerative 2 (6%) 2 (6%) 4 (6%) Nasopharyngitis 3 (9%) 1 (3%) 4 (6%) Pyrexia 0 (0%) 4 (11%) 4 (6%) Hematochezia 0 (0%) 3 (9%) 3 (4%) Nausea 0 (0%) 3 (9%) 3 (4%) Influenza 1 (3%) 2 (6%) 3 (4%) Fatigue 2 (6%) 1 (3%) 3 (4%) Stomatitis 0 (0%) 2 (6%) 2 (3%) Cough 0 (0%) 2 (6%) 2 (3%) Pharyngolaryngeal pain 2 (6%) 0 (0%) 2 (3%) Dysmenorrhea 2 (6%) 0 (0%) 2 (3%) Postmarketing Experience The following adverse reactions have been identified during post-approval use of balsalazide in clinical practice: myocarditis, pericarditis, vasculitis, pruritus, pleural effusion, pneumonia (with and without eosinophilia), alveolitis, renal failure, interstitial nephritis, pancreatitis, and alopecia. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to balsalazide. Hepatic Postmarketing adverse reactions of hepatotoxicity have been reported for products which contain (or are metabolized to) mesalamine, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal; however, no fatalities associated with these adverse reactions were reported in COLAZAL (balsalazide) clinical trials. One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this adverse reaction was not reported in COLAZAL (balsalazide) clinical trials. Read the Colazal (balsalazide) Side Effects Center for a complete guide to possible side effectsLearn More »

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Adult Dose For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg COLAZAL (balsalazide) 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. Pediatric Dose For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:
  • three 750 mg COLAZAL (balsalazide) capsules 3 times a day (6.75 g per day) for up to 8 weeks;
    OR:
  • one 750 mg COLAZAL (balsalazide) capsule 3 times a day (2.25 g per day) for up to 8 weeks.
Use of COLAZAL (balsalazide) in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. [See Clinical Studies Section] Administration Alternatives COLAZAL (balsalazide) 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 COLAZAL (balsalazide) 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 COLAZAL (balsalazide) in sprinkle form with food.

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In an in vitro study using human liver microsomes, balsalazide and its metabolites [5- aminosalicylic acid (5-ASA), N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), 4- aminobenzoyl-β-alanine (4-ABA) and N-acetyl-4-aminobenzoyl- β - alanine (N-Ac-4- ABA)] were not shown to inhibit the major CYP enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5). Therefore, balsalazide and its metabolites are not expected to inhibit the metabolism of other drugs with are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5. Read the Colazal Drug Interactions Center for a complete guide to possible interactions Learn More »

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Patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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Patients with hypersensitivity to salicylates or to any of the components of COLAZAL capsules or balsalazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No case of overdose has occurred with COLAZAL (balsalazide) . A 3-year-old boy is reported to have ingested 2 g of another mesalamine product. He was treated with ipecac and activated charcoal with no adverse reactions. If an overdose occurs with COLAZAL (balsalazide) , treatment should be supportive, with particular attention to correction of electrolyte abnormalities.

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Dosage Forms And Strengths COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black. Storage And Handling COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black. NDC 65649-101-02 Bottles of 280 capsules.
NDC 65649-101-50 Bottles of 500 capsules. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature. Manufactured for Salix Pharmaceuticals, Inc., Morrisville, NC 27560. * COLAZAL® (balsalazide) is a registered trademark of Salix Pharmaceuticals, Inc. FDA Rev date: 7/9/2008 Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Exacerbations of Colitis In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis. In the pediatric clinical trials, 4 out of 68 patients reported exacerbation of the symptoms of ulcerative colitis. Observe patients closely for worsening of these symptoms while on treatment. Pyloric Stenosis Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL (balsalazide) capsules. Renal Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering COLAZAL (balsalazide) to patients with known renal dysfunction or a history of renal disease. [See Nonclinical Toxicology] Use in specific Populations Pregnancy Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether balsalazide disodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when COLAZAL (balsalazide) is administered to a nursing woman. Pediatric Use Use of COLAZAL (balsalazide) in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by:
  • extrapolation of results from clinical studies that supported the approval of COLAZAL (balsalazide) for adults.
  • a clinical trial of 68 patients ages 5-17 years comparing two doses of COLAZAL (balsalazide) (6.75 g/day and 2.25 g/day), and
  • a pharmacokinetic study performed on a subset of the pediatric study population. [See Adverse Reactions, Clinical Pharmacology, and Clinical Studies].
Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day. Safety and efficacy of COLAZAL (balsalazide) in pediatric patients below the age of 5 years have not been established. Non Clinical Toxicology 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.Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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