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

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • baricitinib

                balsalazide will increase the level or effect of baricitinib by decreasing elimination. Avoid or Use Alternate Drug. Coadministration of baricitinib with strong organic anion transporter 3 (OAT3) inhibitors is not recommended.

              • measles, mumps, rubella and varicella vaccine, live

                balsalazide, measles, mumps, rubella and varicella vaccine, live. Mechanism: unspecified interaction mechanism. Avoid or Use Alternate Drug. Risk of Reye's Syndrome with combination; avoid salicylate use for 6 wks after vaccination.

              • varicella virus vaccine live

                balsalazide, varicella virus vaccine live. Mechanism: unspecified interaction mechanism. Avoid or Use Alternate Drug. Risk of Reye's Syndrome with combination; avoid salicylate use for 6 wks after vaccination.

              Monitor Closely (17)

              • acetazolamide

                acetazolamide, balsalazide. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

                acetazolamide, balsalazide. Mechanism: passive renal tubular reabsorption due to increased pH. Use Caution/Monitor. Salicylate levels increased at moderate doses; risk of CNS toxicity. Salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • azithromycin

                azithromycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • brinzolamide

                brinzolamide, balsalazide. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

              • clarithromycin

                clarithromycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin base

                erythromycin base will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • griseofulvin

                griseofulvin decreases levels of balsalazide by unknown mechanism. Use Caution/Monitor.

              • methazolamide

                methazolamide, balsalazide. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Carbonic anhydrase inhibitors (CAIs) and salicylates inhibit each other's renal tubular secretion, resulting in increased plasma levels. CAIs also shift salicylates from plasma to the CNS, leading to potential neurotoxicity.

              • mycophenolate

                balsalazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

              • pivmecillinam

                pivmecillinam, balsalazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • probenecid

                balsalazide will increase the level or effect of probenecid by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

                balsalazide decreases effects of probenecid by unknown mechanism. Use Caution/Monitor.

              • roxithromycin

                roxithromycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • temocillin

                temocillin, balsalazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • ticarcillin

                ticarcillin, balsalazide. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • voclosporin

                voclosporin, balsalazide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (125)

              • aceclofenac

                aceclofenac will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acemetacin

                acemetacin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acyclovir

                balsalazide will increase the level or effect of acyclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aluminum hydroxide

                aluminum hydroxide, balsalazide. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • amikacin

                amikacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • aminohippurate sodium

                balsalazide will increase the level or effect of aminohippurate sodium by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ascorbic acid

                balsalazide decreases levels of ascorbic acid by increasing renal clearance. Minor/Significance Unknown.

              • aspirin

                aspirin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin rectal

                aspirin rectal will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aztreonam

                aztreonam will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • bendroflumethiazide

                bendroflumethiazide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • budesonide

                budesonide decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • bumetanide

                balsalazide, bumetanide. Other (see comment). Minor/Significance Unknown. Comment: Salicylates are less likely than other NSAIDs to interact w/bumetanide.

              • calcium carbonate

                calcium carbonate, balsalazide. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • cefadroxil

                cefadroxil will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                cefadroxil will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefamandole

                cefamandole will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                cefamandole will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefpirome

                cefpirome will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                cefpirome will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • celecoxib

                celecoxib will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cephalexin

                cephalexin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                cephalexin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorhexidine oral

                chlorhexidine oral will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • chlorothiazide

                chlorothiazide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorpropamide

                balsalazide will increase the level or effect of chlorpropamide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                balsalazide increases effects of chlorpropamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • chlorthalidone

                chlorthalidone will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ciprofloxacin

                ciprofloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • clindamycin

                clindamycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cortisone

                cortisone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • cyanocobalamin

                balsalazide decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cyclopenthiazide

                cyclopenthiazide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • dapsone

                dapsone will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • deflazacort

                deflazacort decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • demeclocycline

                demeclocycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • dexamethasone

                dexamethasone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • diclofenac

                diclofenac will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • diflunisal

                diflunisal will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • doxycycline

                doxycycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ertapenem

                ertapenem will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ethanol

                ethanol increases toxicity of balsalazide by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of GI bleeding.

              • etodolac

                etodolac will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fenoprofen

                fenoprofen will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fleroxacin

                fleroxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • fludrocortisone

                fludrocortisone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • flurbiprofen

                flurbiprofen will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • folic acid

                balsalazide decreases levels of folic acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • fosfomycin

                fosfomycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ganciclovir

                balsalazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • gemifloxacin

                gemifloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • gentamicin

                gentamicin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • glimepiride

                balsalazide increases effects of glimepiride by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • glipizide

                balsalazide increases effects of glipizide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • glyburide

                balsalazide increases effects of glyburide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • hydrochlorothiazide

                hydrochlorothiazide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • hydrocortisone

                hydrocortisone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • ibuprofen

                ibuprofen will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen IV

                ibuprofen IV will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indapamide

                indapamide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indomethacin

                indomethacin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • insulin aspart

                balsalazide increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin detemir

                balsalazide increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin glargine

                balsalazide increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin glulisine

                balsalazide increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin lispro

                balsalazide increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin NPH

                balsalazide increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • insulin regular human

                balsalazide increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown. Large dose of salicylate.

              • ketoprofen

                ketoprofen will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac

                ketorolac will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac intranasal

                ketorolac intranasal will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • L-methylfolate

                balsalazide decreases levels of L-methylfolate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • levofloxacin

                levofloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • linezolid

                linezolid will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • lornoxicam

                lornoxicam will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meclofenamate

                meclofenamate will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mefenamic acid

                mefenamic acid will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meloxicam

                meloxicam will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meropenem

                meropenem will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • meropenem/vaborbactam

                meropenem/vaborbactam will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • mesalamine

                balsalazide will increase the level or effect of mesalamine by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methyclothiazide

                methyclothiazide will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methylprednisolone

                methylprednisolone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • metolazone

                metolazone will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • metronidazole

                metronidazole will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • minocycline

                minocycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • moxifloxacin

                moxifloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • nabumetone

                nabumetone will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • naproxen

                naproxen will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • neomycin PO

                neomycin PO will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • nitrofurantoin

                nitrofurantoin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ofloxacin

                ofloxacin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • oxaprozin

                oxaprozin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • oxytetracycline

                oxytetracycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • parecoxib

                parecoxib will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • paromomycin

                paromomycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • piroxicam

                piroxicam will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • pivmecillinam

                pivmecillinam will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • prednisolone

                prednisolone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • prednisone

                prednisone decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • quinupristin/dalfopristin

                quinupristin/dalfopristin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • rose hips

                rose hips will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                balsalazide decreases levels of rose hips by increasing renal clearance. Minor/Significance Unknown.

                rose hips increases levels of balsalazide by decreasing renal clearance. Minor/Significance Unknown.

              • salicylates (non-asa)

                salicylates (non-asa) will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salsalate

                salsalate will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sodium bicarbonate

                sodium bicarbonate, balsalazide. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • sodium citrate/citric acid

                sodium citrate/citric acid, balsalazide. Mechanism: passive renal tubular reabsorption due to increased pH. Minor/Significance Unknown. Salicylate levels increased at moderate doses; salicylate levels decreased at large doses (d/t increased renal excretion of unchanged salicylic acid).

              • streptomycin

                streptomycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • sulfadiazine

                sulfadiazine will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                balsalazide increases levels of sulfadiazine by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfamethoxazole

                sulfamethoxazole will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                balsalazide increases levels of sulfamethoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulfasalazine

                sulfasalazine will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulfisoxazole

                sulfisoxazole will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

                balsalazide increases levels of sulfisoxazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • sulindac

                sulindac will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • teicoplanin

                teicoplanin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • temocillin

                temocillin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • tetracycline

                tetracycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ticarcillin

                ticarcillin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • tigecycline

                tigecycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • tobramycin

                tobramycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • tolazamide

                balsalazide increases effects of tolazamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • tolbutamide

                balsalazide increases effects of tolbutamide by plasma protein binding competition. Minor/Significance Unknown. Large dose of salicylate.

              • tolfenamic acid

                tolfenamic acid will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolmetin

                tolmetin will increase the level or effect of balsalazide by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

              • trimethoprim

                trimethoprim will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • valganciclovir

                balsalazide will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • vancomycin

                vancomycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • verapamil

                verapamil increases effects of balsalazide by unknown mechanism. Minor/Significance Unknown. Enhanced antiplatelet activity.

              • willow bark

                balsalazide will increase the level or effect of willow bark by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

                willow bark increases effects of balsalazide by pharmacodynamic synergism. Minor/Significance Unknown. Willow bark contains salicylic acid, which may have additive effects/toxicity with salicylate drugs.

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              balsalazide oral
              -
              750 mg capsule
              balsalazide oral
              -
              750 mg capsule
              balsalazide oral
              -
              750 mg capsule
              balsalazide oral
              -
              750 mg capsule
              Colazal oral
              -
              750 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              balsalazide oral

              BALSALAZIDE CAPSULE - ORAL

              (bal-SAL-a-zide)

              COMMON BRAND NAME(S): Colazal

              USES: Balsalazide is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon.

              HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor.Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones.If you have trouble swallowing the capsules, you may open them and sprinkle the contents onto a spoonful of applesauce. Swallow the food/medication mixture right away. Do not prepare a supply in advance.The dosage is based on your age, medical condition, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition does not get better or if it gets worse.

              SIDE EFFECTS: Headache, nausea, vomiting, joint pain, diarrhea, abdominal pain, fever, sore throat, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Rarely, balsalazide can worsen ulcerative colitis. Tell your doctor right away if your symptoms worsen after starting this medication (for example, if you have increased abdominal pain, rectal bleeding).Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting, burning/painful urination, fast/pounding heartbeat.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking balsalazide, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as mesalamine, olsalazine); or to salicylates (e.g., aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain stomach/intestinal condition (pyloric stenosis), liver disease, kidney disease.This medication may make you more sensitive to the sun, especially if you have skin problems (such as atopic dermatitis, eczema). Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as heart failure).This medication is similar to aspirin. Children and teenagers younger than 18 years should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: dichlorphenamide.Balsalazide is very similar to mesalamine. Do not use mesalamine medications taken by mouth while using balsalazide.This medication may interfere with certain lab tests (including urine normetanephrine levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.