balsalazide (Rx)

Brand and Other Names:Colazal, Giazo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 750mg (Colazal)

tablet

  • 1.1g (Giazo)
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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)
more...

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%)

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            Warnings

            Contraindications

            Hypersensitivity to salicylates, balsalazide, mesalamine

            Cautions

            Sulfasalazine hypersensitivity, coagulation abnormalities, pyloric stenosis, renal/hepatic impairment, allergy, asthma

            Risk of exacerbation of ulcerative colitis

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: not known whether drug or metabolites are distributed into breast milk, use caution

            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 intersubject variability

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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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