Balsalazide Disodium is an aminosalicylate sold in the U.S. under 2 brand and generic names, for ulcerative colitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Colazal (application NDA020610). Other balsalazide disodium products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adult dose is three 750 mg balsalazide disodium capsules 3 times a day (6.75 g/day) with or without food for 8 weeks. Some adult patients required treatment for up to 12 weeks. (2.1) Pediatric dose is EITHER: (2.2 , 8.4) 1. Three 750 mg balsalazide disodium capsules 3 times a day (6.75 g/day) with or without food for 8 weeks. OR: 2. One 750 mg balsalazide disodium capsule 3 times a day (2.25 g/day) with or without food for up to 8 weeks. Capsules may be swallowed whole or may be opened and sprinkled on applesauce, then chewed or swallowed immediately. (2.3, 12.3) 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 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 (incidence ≥3%) are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. Adverse reactions in children were similar. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 in 4 controlled trials. In the 4…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $11 | View → | |
| 2 | 72/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| P;840 | 1.1 g | yellow | oval | — |
| APO;B750 | 750 mg | white | capsule | — |
| 54;795 | 750 mg | orange | capsule | — |
| 126 | 750 mg | orange, orange | capsule | — |
| 1626 | 750 mg | yellow | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Balsalazide disodium capsules is 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)]. Known or suspected hypersensitivity to salicylates, aminosalicylates, or any of the components of balsalazide disodium capsules or balsalazide metabolites. (4, 5.3)
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)]. 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of balsalazide disodium capsules and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference With Urinary Normetanephrine Measurements Use of balsalazide disodium capsules, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.9)]. Consider an alternative, selective assay for normetanephrine. In an in vitro study using human liver microsomes, balsalazide and its metabolites were not shown to inhibit the major CYP enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5). (7)
| $11 |
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