Balsalazide
Indications
Balsalazide is used for:
Ulcerative colitis
Adult Dose
Oral
Ulcerative colitis
Adult: Acute attack: 2.25 g tid, until remission occurs or up to 12 wk. Maintenance: 1.5 g bid, adjusted according to response. Max: 6 g daily.
Hepatic impairment: Severe: Contraindicated.
Child Dose
Oral
Ulcerative colitis
Child: 5-17 yr 750 mg tid or 2.25 g tid, treatment may continue for up to 8 wk.
Renal Dose
Renal impairment: Moderate to severe: Contraindicated.
Administration
Should be taken with food. Take w/ or immediately after meals.
Contra Indications
Severe hepatic and moderate to severe renal impairment.
Precautions
Patient w/ pyloric stenosis, asthma, bleeding disorders, active peptic ulcer disease. Mild to moderate hepatic and mild renal impairment or history of renal disease. Pregnancy and lactation. Monitoring Parameters Monitor renal function, LFT and CBC.
Pregnancy-Lactation
Pregnancy
Published data from meta-analyses, cohort studies and case series on use of mesalamine, the active moiety of the drug, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes
Published data suggest that increased disease activity is associated with risk of developing adverse pregnancy outcomes in women with ulcerative colitis; adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth
Animal data
There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy; in animal reproduction studies, there were no adverse developmental effects observed after oral administration in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (MRHD)
Lactation
Data from published literature report presence of mesalamine and metabolite, N acetyl-5 aminosalicylic acid, in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalamine; there are case reports of diarrhea in breastfed infants exposed to mesalamine; there is no information on effects of drug on milk production
Lack of clinical data during lactation precludes a clear determination of risk of drug to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Increased risk of blood dyscrasias w/ azathioprine and 6-mercaptopurine. Increased nephrotoxicity when used w/ NSAIDs. May decrease serum concentration of cardiac glycosides.
Side Effects
Side effects of Balsalazide :
>10%
Headache (15% peds)
Abdominal pain (13% peds )
Vomiting (10% peds)
1-10% (Adults)
Headache (8%)
Abdominal pain (6%)
Nausea (5%)
Diarrhea (5%)
Respiratory infection (4%)
Arthralgia (4%)
Vomiting (4%)
Fatigue (2%)
Insomnia (2%)
Cough (2%)
Pharyngitis (2%)
Rhinitis (2%)
Dyspepsia (2%)
Anorexia (2%)
Flatulence (2%)
Fever (2%)
Constipation (1%)
Cramps (1%)
Ulcerative colitis exacerbation (1%)
Flu like syndrome (1%)
Myalgia (1%)
UTI (1%)
Xerostomia (1%)
1-10% (Pediatrics)
Diarrhea (9%)
Fever (6%)
Ulcerative colitis exacerbation (6%)
Pharyngitis (6%)
Fatigue (4%)
Flu like syndrome (4%)
Nausea (4%)
Hematochezia (4%)
Cough (3%)
Dysmenorrhea (3%)
Stomatitis (3%)
Mode of Action
Balsalazide is a prodrug of mesalazine which is linked to 4-aminobenzoyl-β-alanine via an azo bond. W/ the release of mesalazine, it reduces inflammation by inhibiting cyclooxygenase and leukotriene synthesis, thus blocking the formation of arachidonic acid in the colonic mucosa.