BALSALAZIDE DISODIUM- balsalazide disodium capsule
Hikma Pharmaceuticals USA Inc.
1 INDICATIONS AND USAGE
Balsalazide disodium capsules are 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 balsalazide disodium capsules 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 balsalazide disodium capsules [see Warnings and Precaution (5.1)].
- Swallow balsalazide disodium capsules whole. Do not cut, break, crush or chew the capsules.
- For patients who cannot swallow intact capsules, balsalazide disodium capsules 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 balsalazide disodium capsules 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 balsalazide disodium capsules 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
Balsalazide Disodium Capsules, USP are available as light orange opaque capsules containing 750 mg balsalazide disodium, USP and “54 795” printed in black ink on the cap and body, containing a yellow-orange powder.
Balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium 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 balsalazide disodium capsules that release mesalamine into the gastrointestinal tract. Evaluate renal function prior to initiation of balsalazide disodium capsules and periodically while on therapy. Evaluate the risks and benefits of using balsalazide disodium capsules in patients with known renal impairment, a history of renal disease or taking nephrotoxic drugs. Discontinue balsalazide disodium capsules 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 balsalazide disodium capsules.
5.3 Hypersensitivity Reactions
Some patients have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to balsalazide disodium capsules 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 balsalazide disodium capsules 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 balsalazide disodium capsules 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 balsalazide disodium capsules [see Adverse Reactions (6.2)].
Discontinue balsalazide disodium capsules 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 balsalazide disodium capsules, which would delay mesalamine release in the colon. Avoid balsalazide disodium capsules 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 balsalazide disodium capsules, 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 balsalazide disodium capsules.
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