Disodium edetate

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. Balsalazide disodium capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) Limitations of Use: Safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. ( 1 )

• Administration Instructions: Evaluate renal function before initiating therapy with balsalazide disodium capsules
• Swallow capsules whole
• Do not cut, break, crush or chew
• For patients who cannot
• Swallow intact capsules, the capsules may be opened and sprinkled on applesauce, then chewed and swallowed immediately
• Teeth and/or tongue staining may occur when administered sprinkled on applesauce
• Drink an adequate amount of fluids
• Take balsalazide disodium capsules with or without food
• Dosage: Adults: The recommended dosage is 2.25 g (three 750 mg capsules) three times daily for 8 weeks
• Some adult patients required treatment for up to 12 weeks in clinical trials
• Pediatric Patients 5 Years to 17 Years of Age: The recommended dosage is either : 2.25 g (three 750 mg capsules) three times for up to 8 weeks
• OR: 750 mg (one capsule) three times daily for up to 8 weeks
• Important Preparation and Administration Instructions Evaluate renal function before initiating therapy with balsalazide disodium capsules [see Warnings and Precaution ]
• Swallow balsalazide disodium capsules whole

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. Capsules: 750 mg ( 3 )

• The safety and effectiveness of balsalazide disodium capsules has been established
• For the treatment of mildly to moderately active ulcerative colitis
• In pediatric and adolescent patients 5 years to 17 years of age
• Use of balsalazide disodium capsules for this indication is supported by evidence from adequate and well-controlled clinical studies
• In adults with additional pharmacokinetic and safety data
• In pediatric patients aged 5 years to 17 years [see Adverse Reactions , Clinical Pharmacology , and Clinical Studies ] . …

• Renal Impairment: Inform patients that balsalazide disodium capsules may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy
• Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions , Drug Interactions ]
• Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions: Inform patients of the signs and symptoms of hypersensitivity reactions. …

• 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 , Adverse Reactions , Description ]
• Known or suspected hypersensitivity to salicylates, aminosalicylates, or any of the components of balsalazide disodium capsules or balsalazide metabolites

Nephrotoxic Agents including NSAIDs : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6-Mercaptopurine : Increased risk of blood disorders; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of renal reactions. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions ( 5.1 )] . …

Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue if renal function deteriorates. ( 5.1 , 7.1 , 8.6 ) Mesalamine-Induced Acute Intolerance Syndrome: Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 ) Hypersensitivity Reactions, including Myocarditis and Pericarditis : Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. …

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 )] Most common adverse reactions (≥3%) are: headache, abdominal pain, diarrhea, naus …

8.1 Pregnancy Risk Summary: Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety of balsalazide, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . …

Balsalazide disodium is an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.