balsalazide (Rx)

Brand and Other Names:Colazal, Giazo (dsc)
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 750mg (Colazal)

tablet (dsc)

  • 1.1g (Giazo)

Ulcerative Colitis

Colazal: 3 capsules (2.25 g total) PO TID (total dose 6.75 g/day x 8-12 weeks

Giazo (males): 3 tablets (3.3 g total) PO BID (total dose 6.6 g/day) x 8 weeks

Dosing Considerations

Giazo: Locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older; effectiveness in female patients was not demonstrated in clinical trials

Administration

May take with or without food

Colazal: Swallow capsule whole, or open capsule, sprinkle contents on applesauce and chew or swallow immediately

Dosage Forms & Strengths

capsule

  • 750mg (Colazal)

Ulcerative Colitis

Giazo: Safety and efficacy not established in children <18 years

5-17 years (Colazal)

  • <5 years: Safety and efficacy not established
  • May initiate at either 6.75 g/day or 2.25 g/day
  • 3 capsules (2.25 g total) PO TID (total dose 6.75 g/day) x8 weeks, OR
  • 1 capsule (750 mg) PO TID (total dose 2.25 g/day) for up to 8 weeks

Administration

May take with or without food

Colazal: Swallow whole, or open capsule, sprinkle contents on applesauce and chew or swallow immediately

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Interactions

Interaction Checker

and balsalazide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >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%)

            Postmarketing Reports

            Cardiovascular and vascular: Myocarditis, pericarditis, vasculitis

            Respiratory: Alveolitis, pleural effusion, pneumonia (with and without eosinophilia)

            Gastrointestinal: Pancreatitis

            Renal: Interstitial nephritis, renal failure, nephrolithiasis

            Hepatobiliary disorders: Elevated liver enzymes (AST, ALT, GGT, LDH, alkaline phosphatase), elevated bilirubin, jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure, Kawasaki-like syndrome including hepatic dysfunction; some of these cases were fatal

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            Warnings

            Contraindications

            Hypersensitivity to salicylates, balsalazide, mesalamine

            Cautions

            Risk of exacerbation of ulcerative colitis

            Assess renal function at beginning of treatment and periodically during treatment; evaluate risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function.

            Mesalamine-induced acute intolerance syndrome symptoms may be difficult to distinguish from exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome suspected

            Hypersensitivity reactions, including myocarditis and pericarditis, reported; evaluate patients immediately and discontinue if hypersensitivity reaction is suspected

            Hepatic failure reported; evaluate risks and benefits in patients with known liver impairment

            Photosensitivity reported; advice patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

            Nephrolithiasis reported; stones containing mesalamine, the active moiety, are undetectable by standard radiography or computed tomography (CT). ensure adequate fluid intake during treatment

            Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection

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            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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Metabolized to mesalamine by intestinal flora

            Mesalamine (5-aminosalicylic acid) has anti-inflammatory effect; active component of sulfasalazine, specific MOA unknown; probably inhibits prostaglandin & leukotrienes synthesis & release in colon

            Absorption

            Bioavailability: Low absorption

            Onset: 10 days to 2 wk

            Peak plasma time: 1-2 hr

            Distribution

            Protein bound: 99%

            Vd: mesalamine: 0.2 L/kg

            Metabolism

            Following oral administration, balsalazide passes intact into colon where it is cleaved by intestinal flora to form mesalamine and 4-aminobenzoyl-b-alanine

            Mesalamine is rapidly acetylated in colon wall and liver, independent of pt. acetylator status, into N-acetyl-5-aminosalycylic acid

            Metabolites: mesalamine (active), N-acetyl-5-aminosalycylic acid (inactive), 4-aminobenzoyl-b-alanine (inactive)

            Elimination

            Half-life: Undetermined due to large intersubjective variability

            Excretion: Feces (as metabolites) >65%; urine (as metabolites) >25%

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.