COLAZAL- balsalazide disodium capsule
Salix Pharmaceuticals, Inc
1 INDICATIONS AND USAGE
COLAZAL® is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Limitations of Use
Safety and effectiveness of COLAZAL beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.
2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Instructions
- Evaluate renal function before initiating therapy with COLAZAL [see Warnings and Precaution (5.1)].
- Swallow COLAZAL capsules whole. Do not cut, break, crush or chew the capsules.
- For patients who cannot swallow intact capsules, COLAZAL may also be administered by opening the capsule and sprinkling the capsule contents on applesauce. 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.
- Place a small amount (approximately 10 mL) of applesauce into a clean container.
- Carefully open the capsules.
- Sprinkle the capsule contents on the applesauce.
- Mix the capsule contents with the applesauce. The contents may be chewed, if necessary.
- Consume the entire amount of applesauce mixture immediately. Do not store the applesauce mixture for future use.
- Teeth and/or tongue staining may occur in some patients when administered sprinkled on applesauce.
- Drink an adequate amount of fluids [see Warnings and Precautions (5.8)].
- Take COLAZAL with or without food [see Clinical Pharmacology (12.3)].
2.2 Recommended Dosage in Adults and Pediatric Patients 5 Years to 17 Years of Age
The recommended dosage in adults is 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.
Pediatric Patients 5 Years to 17 Years of Age
The recommended dosage in pediatric patients 5 years to 17 years of age is either:
- 2.25 g (three 750 mg capsules) three times daily for up to 8 weeks;
- 750 mg (one capsule) three times daily for up to 8 weeks.
Use of COLAZAL in the pediatric population for more than 8 weeks has not been evaluated in clinical trials [see Clinical Studies (14)].
3 DOSAGE FORMS AND STRENGTHS
COLAZAL is available as beige capsules containing 750 mg balsalazide disodium and CZ imprinted in black.
COLAZAL is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of COLAZAL capsules or balsalazide metabolites [see Warnings and Precautions (5.3), Adverse Reactions (6.2),Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Renal Impairment
Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as COLAZAL that release mesalamine into the gastrointestinal tract. Evaluate renal function prior to initiation of COLAZAL and periodically while on therapy. Evaluate the risks and benefits of using COLAZAL in patients with known renal impairment, a history of renal disease or taking nephrotoxic drugs. Discontinue COLAZAL if renal function deteriorates while on therapy [see Drug Interactions (7.1), Use in Specific Populations (8.6) ].
5.2 Mesalamine-Induced Acute Intolerance Syndrome
Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. Monitor patients for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with COLAZAL.
5.3 Hypersensitivity Reactions
Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to COLAZAL or to other compounds that contain or are converted to mesalamine.
Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue COLAZAL if an alternative etiology for the signs and symptoms cannot be established.
5.4 Hepatic Failure
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Because balsalazide is converted to mesalamine, evaluate the risks and benefits of using COLAZAL in patients with known liver impairment.
5.5 Severe Cutaneous Adverse Reactions
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine, the active moiety of COLAZAL [see Adverse Reactions (6.2)]. Discontinue COLAZAL at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
5.6 Upper Gastrointestinal Tract Obstruction
Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of COLAZAL, which would delay mesalamine release in the colon. Avoid COLAZAL in patients at risk of upper gastrointestinal tract obstruction.
Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
Cases of nephrolithiasis have been reported with the use of mesalamine, the active moiety of COLAZAL, including stones with 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with COLAZAL.
5.9 Interference with Laboratory Tests
Use of COLAZAL, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Renal Impairment [see Warnings and Precautions (5.1)]
- Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
- Hepatic Failure [see Warnings and Precautions (5.4)]
- Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)]
- Upper Gastrointestinal Tract Obstruction [see Warnings and Precautions (5.6)]
- Photosensitivity [see Warnings and Precautions (5.7)]
- Nephrolithiasis [see Warnings and Precautions (5.8)]
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