Balsalazide
COLAZAL
Pronunciation: bal-SAL-a-zide
“Colossal Ball salad”
What it is5-ASA prodrug cleaved by colonic bacteria; ulcerative colitis.
Why this oneIts inert carrier delivers mesalamine to the colon without sulfasalazine's sulfapyridine-related adverse effects.
What limits itA large capsule burden hurts adherence. Interstitial nephritis as for the class.
FDA-approved for
- mild-to-moderate ulcerative colitis (1996)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Mildly to moderately active ulcerative colitis | Adult | 2.25 g (three 750 mg caps) TID | 2.25 g TID (6.75 g/day) × 8 wk | 6.75 g/day; up to 12 wk (safety beyond 12 wk not established) |
| Mildly to moderately active ulcerative colitis | Children 5–17 yr | 750 mg (1 cap) TID or 2.25 g (3 caps) TID | 750 mg TID or 2.25 g TID × up to 8 wk | 6.75 g/day; up to 8 wk |
Renal Evaluate renal function before and periodically; weigh risk/benefit and monitor in known impairment; discontinue if renal function deteriorates (no dose adjustment given)
Hepatic Caution — hepatic failure reported in pre-existing liver disease; weigh risk/benefit (no dose adjustment given)
Limitation of use: safety/effectiveness beyond 8 wk (peds) and 12 wk (adults) not established.
Instructions
- Swallow capsules whole; do not cut, break, crush or chew
- If unable to swallow: open and sprinkle on ~10 mL applesauce, chew if needed and consume immediately (may stain teeth/tongue)
- Drink adequate fluids
- Take with or without food
Available strengths
- cap 750 mg
Contraindications
- Known or suspected hypersensitivity to salicylates, aminosalicylates, or balsalazide metabolites
Cautions
- Renal impairment (minimal change disease, interstitial nephritis, renal failure) — assess renal function
- Mesalamine-induced acute intolerance syndrome (mimics UC flare)
- Hypersensitivity incl. myocarditis/pericarditis
- Hepatic failure in pre-existing liver disease
- Severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP)
- Upper GI tract obstruction (pyloric stenosis) — avoid
- Photosensitivity
- Nephrolithiasis (radiolucent mesalamine stones) — ensure fluids
- Interference with urinary normetanephrine assay
Adverse reactions
- Headache (8%)
- Abdominal pain (6%)
- Diarrhea (5%)
- Nausea (5%)
- Vomiting (4%)
- Respiratory infection (4%)
- Arthralgia (4%)
Pregnancy Published mesalamine data have not reliably shown association with major birth defects, miscarriage, or adverse outcomes; no adverse developmental effects in rats/rabbits.
Lactation Mesalamine and N-acetyl metabolite present in milk in small amounts (RID ≤0.1%); diarrhea reported in breastfed infants — monitor.
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 750 mg | cap | 60 BID | $20.66 | offered |
Generic entry2007
NO BOXED WARNINGS
Principal riskCapsule burden; interstitial nephritis
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.